title: Immunotherapy by Nivolumab in Neoadjuvant and Adjuvant Setting in Patients With Advanced HCC Treated by Electroporation in Curative Intent: French Multicenter Phase 2 Therapeutic Trial.

acronym: NIVOLEP

summary:
Percutaneous ablation (PA) is the only non-surgical curative treatment of hepatocellular carcinoma (HCC). Due to its excellent tolerance, particularly in patients with portal hypertension or bearing comorbidities, it now represents in France nearly 70% of the first-line curative treatment of "in Milan" tumours. For HCC less than 3 cm, ideal indication for percutaneous ablations, results of monopolar radiofrequency ablation (mRFA), are excellent with only 5% of reported non-tumoral control after a first procedure .

In addition to mRFA the arsenal of ablations has grown considerably with the emergence of new techniques. They allow the expansion of indications for PA, especially in patients with poor prognostic tumors or relatively advanced beyond the Milan criteria . In this setting, multibipolar mode using no touch technique (mbpRFAnt) increases the tumour volume that can be ablated, allowing the removal of large tumors> 5 cm . Furthermore, electroporation (EP) is a new PA technique that does not promote thermoablation but induce tumoral cells apoptosis and is particularly interesting for difficult-to-treat lesions located near vascular or biliary trunks . Inadequate tumour control is then de facto greater in these situations, around 20% at one year.

The idea of optimizing HCC curative treatments using neoadjuvant or adjuvant biotherapy, particularly in patients with advanced tumors in curative intent, is particularly attractive. One trial in adjuvant setting was conducted, the STORM trial, that tested the benefit of sorafenib in curative intent of in Milan HCC. This negative trial included patients with in Milan HCC, with an expected low rate of recurrence with only few patients treated by PA.

In parallel, the development of new molecules for HCC treatment, especially immunotherapy, seems to give promising results in palliative setting . Furthermore, PA procedures and most likely electroporation induce T-cell recruitement that may foster immunomodulation .

Neoadjuvant and adjuvant trials using these new molecules must now be cautiously designed based on the rigorous selection of special populations and therapeutic indications.

This project proposes a Phase 2 trial testing the safety and efficacy of treatment with Nivolumab in neoadjuvant and adjuvant setting in patients with advanced HCC treated by electroporation in curative intent.

ReferenceCitation: Sutter O, Calvo J, N'Kontchou G, Nault JC, Ourabia R, Nahon P, Ganne-Carrié N, Bourcier V, Zentar N, Bouhafs F, Sellier N, Diallo A, Seror O. Safety and Efficacy of Irreversible Electroporation for the Treatment of Hepatocellular Carcinoma Not Amenable to Thermal Ablation Techniques: A Retrospective Single-Center Case Series. Radiology. 2017 Sep;284(3):877-886. doi: 10.1148/radiol.2017161413. Epub 2017 Apr 28.

ReferenceCitation: Bruix J, Takayama T, Mazzaferro V, Chau GY, Yang J, Kudo M, Cai J, Poon RT, Han KH, Tak WY, Lee HC, Song T, Roayaie S, Bolondi L, Lee KS, Makuuchi M, Souza F, Berre MA, Meinhardt G, Llovet JM; STORM investigators. Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2015 Oct;16(13):1344-54. doi: 10.1016/S1470-2045(15)00198-9. Epub 2015 Sep 8.

family: Bruix

full_name: Jordi Bruix

given: Jordi

family: Takayama

full_name: Tadatoshi Takayama

given: Tadatoshi

family: Mazzaferro

full_name: Vincenzo Mazzaferro

given: Vincenzo

family: Chau

full_name: Gar-Yang Chau

given: Gar-Yang

family: Yang

full_name: Jiamei Yang

given: Jiamei

family: Kudo

full_name: Masatoshi Kudo

given: Masatoshi

family: Cai

full_name: Jianqiang Cai

given: Jianqiang

family: Poon

full_name: Ronnie T Poon

given: Ronnie T

family: Han

full_name: Kwang-Hyub Han

given: Kwang-Hyub

family: Tak

full_name: Won Young Tak

given: Won Young

family: Lee

full_name: Han Chu Lee

given: Han Chu

family: Song

full_name: Tianqiang Song

given: Tianqiang

family: Roayaie

full_name: Sasan Roayaie

given: Sasan

family: Bolondi

full_name: Luigi Bolondi

given: Luigi

full_name: Kwan Sik Lee

given: Kwan Sik

family: Makuuchi

full_name: Masatoshi Makuuchi

family: Souza

full_name: Fabricio Souza

given: Fabricio

family: Berre

full_name: Marie-Aude Le Berre

given: Marie-Aude Le

family: Meinhardt

full_name: Gerold Meinhardt

given: Gerold

family: Llovet

full_name: Josep M Llovet

given: Josep M

journal_name: The Lancet Oncology

ReferenceCitation: El-Khoueiry AB, Sangro B, Yau T, Crocenzi TS, Kudo M, Hsu C, Kim TY, Choo SP, Trojan J, Welling TH Rd, Meyer T, Kang YK, Yeo W, Chopra A, Anderson J, Dela Cruz C, Lang L, Neely J, Tang H, Dastani HB, Melero I. Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial. Lancet. 2017 Jun 24;389(10088):2492-2502. doi: 10.1016/S0140-6736(17)31046-2. Epub 2017 Apr 20.

family: El-Khoueiry

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University College London - UCL Discovery


title: Additive Value of Biological and Electrocardiographic Biomarkers for Risk Stratification in Hypertension

summary:
Risk stratification of hypertensive patients includes assessment of traditional cardiovascular risk factors and subclinical target organ damages particularly left ventricular hypertrophy (LVH).

LVH may routinely screened by transthoracic echocardiography by measuring the left ventricular mass (LVM).

However, transthoracic echocardiography suffers from several pitfalls: poor reproducibility, technical limitations and unavailability at a first evaluation by general practitioners.

Other biomarkers may be particularly helpful in hypertension risk stratification. The amplitude of the R wave in aVL lead is a simple validated ECG parameters of LVH and a strong predictor of cardiovascular events and mortality.

Plasma N-terminal pro Brain Natriuretic Peptide (NT-proBNP) is also strongly related to LVM and is an independent predictor of all-cause mortality in hypertension.

The main objective of our study is to determine the additive prognostic value of R wave in aVL and NT proBNP on all-cause and cardiovascular mortality.

Secondary objectives are to determine the addition prognostic value of NT-proBNP and R wave in aVL combined in comparison to each marker taken into account

This study will include 1600 patients who had a work-up of their hypertension in the Cardiology Department of Croix-Rousse Hospital (Hospices Civils de Lyon, Lyon, France) from January 1997 to January 2014.

Their data will be collected in an Access database; their vital status will be obtained by the INSEE unit CépiDC.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Hopital de la Croix Rousse

lead_sponsor_type: academique

status_simplified: Completed


title: Mapping of the Eloquent Cortex and of Epileptic Networks Using Functional Magnetic Resonance Imaging and Electroencephalography in Epileptic Patients

summary: This study aims improving the outcome after brain resective surgery of epileptic patients by improving presurgical evaluations. In particular the specific goal is to evaluate the ability of non invasive neuroimaging (functional magnetic resonance imaging and electroencephalography) to provide presurgical maps of the functional areas of the brain and of the epileptogenic networks.

status: Unknown status

time_perspective: Other

lead_sponsor: University Hospital, Grenoble

status_simplified: Unknown


title: Phase IV Study Comparing a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohn's Disease - the Molecular Basis

summary: The primary purpose of this study is to compare the efficacy of enteral nutrition compared to steroids in inducing remission of active pediatric Crohn's disease. The main hypothesis of this study is that the use of enteral nutrition induces mucosal healing, whereas steroids do not. This effect may be related to a change of the commensal flora during enteral nutrition.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Bannerjee K, Camacho-Hübner C, Babinska K, Dryhurst KM, Edwards R, Savage MO, Sanderson IR, Croft NM. Anti-inflammatory and growth-stimulating effects precede nutritional restitution during enteral feeding in Crohn disease. J Pediatr Gastroenterol Nutr. 2004 Mar;38(3):270-5.

ReferenceCitation: Heuschkel RB, Menache CC, Megerian JT, Baird AE. Enteral nutrition and corticosteroids in the treatment of acute Crohn's disease in children. J Pediatr Gastroenterol Nutr. 2000 Jul;31(1):8-15.

ReferenceCitation: Heuschkel RB, MacDonald TT, Monteleone G, Bajaj-Elliott M, Smith JA, Pender SL. Imbalance of stromelysin-1 and TIMP-1 in the mucosal lesions of children with inflammatory bowel disease. Gut. 2000 Jul;47(1):57-62.

ReferenceCitation: Belli DC, Seidman E, Bouthillier L, Weber AM, Roy CC, Pletincx M, Beaulieu M, Morin CL. Chronic intermittent elemental diet improves growth failure in children with Crohn's disease. Gastroenterology. 1988 Mar;94(3):603-10.

ReferenceCitation: Ruemmele FM, Roy CC, Levy E, Seidman EG. Nutrition as primary therapy in pediatric Crohn's disease: fact or fantasy? J Pediatr. 2000 Mar;136(3):285-91. Review.

ReferenceCitation: Gailhoustet L, Goulet O, Cachin N, Schmitz J. [Study of psychological repercussions of 2 modes of treatment of adolescents with Crohn's disease]. Arch Pediatr. 2002 Feb;9(2):110-6. French.

lead_sponsor: Hôpital Necker-Enfants Malades

location_facility: Hôpital Necker Enfants Malades, Faculté de Médecine Necker, INSERM EMI0212

intervention_type: Drug


title: Study of Biomarkers That Predict the Evolution of Huntington's Disease

acronym: BIOHD

summary:
Huntington's disease (HD) is a rare, autosomal dominant, progressive neurodegenerative disorder typically becoming noticeable in middle age. It is clinically characterized by progressive involuntary movements (bradykinesia and hyperkinesia), neuropsychiatric disturbances (depression, irritability), and cognitive impairments progressing to dementia.

The striatum (caudate and putamen) is the primary area of neuronal degeneration in HD. Today, there is no validated curative treatment. HD affects approximately 6 000 patients in France and more than 30 000 individuals are considered at risk for this disease.

While the disease gene is discovered and we are capable to do a predictive genetic diagnosis for asymptomatic patients, there is no clinical or biological way to predict the age of onset or the progressive profile of patients.

One of the fundamental characteristics of this disease is its extreme variability from one patient to other both in terms of their evolution and their onset of action. Thus, this inter-individual variability severely limits the genetic counselling and complicating the neurological assessment.

Increasingly, it has been assumed that modifier genes may be the source of this inter-individual variability and that their identification could help the understanding and prediction of disease progression.

Given that the mutant protein is ubiquitous, the molecular dysfunction of neurons could be found in peripheral cells from the bloodstream and will be more accessible to investigation.

study_completion_date_type: Anticipated

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Other


type: Other Identifier

title: Pilot Study: Comparison of Patients' Knowledge of Direct Oral Anticoagulants Between 2 Cardiology Departments Offering or Not a Pharmaceutical Interview

acronym: EDUC-AOD

summary:
Direct oral anticoagulants (Rivaroxaban, Apixaban and Dabigatran) are an alternative to anti-vitamin K drugs and low molecular weight heparins in many cardiovascular diseases.

This new class of anticoagulants represents a particular and very promising advance: they are administered orally, their mechanism of action is rapid and direct on coagulation and their predictable pharmacological action allows for administration at fixed doses. In contrast to anti-vitamin K, there is no need for routine biological monitoring.

However, their therapeutic range is narrow and there is no routine biological monitoring. Rigorous compliance is therefore necessary. In addition, there are no official validated recommendations either for the measurement of anticoagulant activity in certain emergency situations, or for the management of severe bleeding (except recently for Pradaxa®).

Their correct use requires the training and involvement of health professionals as well as information and support for patients.

Pharmaceutical interviews are one of the main ways in which pharmacists can ensure this security through personalized and optimal patient care.

The purpose of these interviews is to:

Reinforce the pharmacist's advisory, educational and preventive roles with patients;
To enhance the pharmacist's expertise in the area of medication;
To evaluate the patient's knowledge of his or her treatment;
To assess the patient's knowledge of his or her treatment; To seek the patient's therapeutic adherence and help him or her to take ownership of his or her treatment;
To evaluate, in the long term, the patient's appropriation of his or her treatment.

In this way, they enable involvement with patients while providing a link between healthcare professionals, which is essential for optimal patient care.

In recent years, numerous studies have been conducted on pharmaceutical interviews in the United Kingdom and the Netherlands.

On the other hand, few studies have been conducted in France to evaluate the clinical impact of pharmaceutical interviewing in medical services.

The aim of this study is to compare patients' knowledge of direct oral anticoagulants between 2 cardiology departments offering or not a pharmaceutical interview.

status: Recruiting

ipd_sharing: Undecided

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Centre Hospitalier Intercommunal de Montreuil

status_simplified: Ongoing


title: Environment and Lung Cancer

acronym: PPE

summary:
Cannabis is the most consumed drug in the world and the French are the main consumers in Europe. The most recognized effects of cannabis on human health are of a neuro-psychic nature. The medical literature on the effects of cannabis on the lung in general, and on lung carcinogenesis in particular, is most often reassuring (Tashkin, Chest 2018; Zhang, Int J Cancer 2015; Ghasemiesfe JAMA Netw. Open. 2019), despite the fact that the concentration of carcinogens in cannabis smoke is higher than that contained in tobacco smoke (Moir, Chem. Res. Toxicol. 2008), and that cannabis smoking has been implicated in the occurrence of ENT cancers. Rather, research focuses on the therapeutic effects of cannabis, especially analgesics, and even on its possible anti-tumor virtues (Abrams, Jama Oncol. 2020). These reassuring data should, however, be viewed with a great deal of caution. On the one hand, the illegal nature of cannabis in most countries and its frequent association with tobacco consumption make studies on the subject difficult and often biased. On the other hand, the daily practice of oncologists, who observe numerous cases of advanced and rapidly progressive lung cancer occurring in young patients who are heavy users of cannabis, raises suspicion of an unrecognized role of cannabis in lung carcinogenesis.

In a preliminary multicenter study on French patients under 50 years of age operated for primary lung cancer (Betser, ERJ 2021), we demonstrated that cannabis consumption was extremely frequent, concerning 43% of patients, but mentioned in patients' medical records only in 4 out of 10 cases, while the smoking status was always noted.

In addition, by comparing people who smoke cannabis (always here associated with tobacco) to patients who only smoke tobacco or to non-smokers, we identified a different profile of lung cancers, with more poorly differentiated tumors, presenting at a more advanced stage (more T3-T4 versus T1-T2) requiring more complex surgery, and mostly located in the upper lobes of the lung.

Similar research work is currently underway at Gustave Roussy (Dr Pradere-Dr Planchard, Villejuif, France) on patients with metastatic lung cancer, with a focus on overall survival and molecular profile.

design_allocation: Non-Randomized

primary_purpose: Health Services Research

lead_sponsor: Centre Chirurgical Marie Lannelongue

location_facility:
Institut Gustave Roussy
Centre Chirurgical Marie Lannelongue

lead_sponsor_type: industriel


title: "Effect of the Consumption of a Fermented Dairy Product on Gastrointestinal Well-being in a Healthy Population of Women With Minor Digestive Symptoms"

summary: The purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on the improvement of gastrointestinal well being and digestive symptoms in adult women reporting minor digestive troubles among the general population.

primary_purpose: Prevention

lead_sponsor: Danone Research


title: Assessment of the Impact of COVID-19 on Transplant Patients and on Patients Awaiting Transplantation

acronym: COWAIT

summary: To provide optimal care to patients and to maintain long-term institutional viability, Transplant Centres (TC) must have an awareness of their patients' health status, their health care needs and priorities, as well as their access to information and health care. For example, it is critical that TCs understand whether their patients are medically suitable for transplant, whether transplantation remains a priority for their patients, how best to communicate with their patients, and whether their patients have sufficient access to medications and health care to undergo transplant safely. The COVID-19 pandemic has had a tremendous impact on people and institutions around the country in a short period of time. At this time, little is known regarding its impact on the transplant community specifically. For example, it has been reported that around 8 million French applied for partial unemployment benefit over the past month, but it is not known if this has affected transplant patients. It has been reported that people with significant chronic medical conditions and those with compromised immune systems may be at increased risk of dying from the COVID-19, but it is not known if this has affected patients' interest in receiving transplants at this time. The "Société Francophone de Transplantation (SFT)" published recommendations at the beginning of the pandemic in order to limit the rate of infection in these high-risk population. The purpose of this study is to better understand the impact of COVID-19 on patients on the waiting list and transplant patients. Further, a better understand on how patients have received information about this pandemic and how best to communicate with them.

lead_sponsor: University Hospital, Bordeaux


title: Ultrasonography Features of the Salivary Glands in Patient With Systemic Sclerosis: Comparison With Gougerot-Sjogren Syndrome and Sicca Asthenia Polyalgia Syndrome

summary:
Systemic sclerosis is an autoimmune connective tissue disease with undefined etiology and characterized by progressive fibrosis of the skin and major organs. Dry eyes and / or buccal syndrome is commonly reported in patients with systemic sclerosis. Goujerot-Sjogren syndrome is a chronic autoimmune disorder that is characterized by dryness of the eyes (xerophthalmia) and / or mouth (xerostomia). It may be primary or secondary to another connective tissue disease (such as lupus, rheumatoid arthritis or other). Several criteria have been validated to classify the SS but require a labial salivary gland biopsy, invasive act which complications can sometimes be reported (hematoma, lip sensory defect).

Several scores based on the evaluation of the ultrasound homogeneity of the salivary glands were developed but no studies have evaluated ultrasound abnormalities of salivary glands in patients with systemic sclerosis.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Evaluation of the PS100B for the Diagnostic of Stroke With Patients Out of Delay for Thrombolysis or Thrombectomy

summary:
Numerous patients are addressed to the Emergency Department for unspecific symptoms which can evoke a stroke, such as vertigo, isolated motor deficit, behavior disorder.

For these patients, when they arrive out of time for specific treatments such as thrombolysis and thrombectomy, the cerebral imagery is not an emergency, but necessary to confirm or invalidate the diagnostic of stroke.

If a biomarker could exclude the diagnostic of stroke, we could avoid an imagery for these patients.

PS100B is a biomarker whose blood level increases in case of stroke. It has already proven a prognostic value. Until now, it hasn't proven a diagnostic value because it take a few hours to increase in the blood.

It could have in prognostic value for patients who have the symptoms for more than 24 hours.

STROkE is a diagnostic, prospective, monocentric study, conducted at University Hospital Center of Poitiers (France).

The aim is to determine the value of PS100B to exclude the diagnostic of a stroke in case of evocative symptoms, for patients who are out of delay for a thrombolysis or a thrombectomy.

Patients eligible are the ones who present to the emergency department with symptoms evocative of stroke for more than 24 hours and less than 4 days. Patients included have a sample of blood withdrawn, in order to measure PS100B blood level.

The diagnostic of stroke is than confirmed or excluded by an adjudication comity, who are unaware of the result of PS100B blood level.

The diagnostic value of PS100B is determined with the help of a ROC curve.

lead_sponsor: Poitiers University Hospital


title: Randomized Study Evaluating the Cost Impact and Effectiveness of Systematic Liver Fast-MRI Surveillance for Early-stage Hepatocellular Carcinoma in High-risk Patients Included in Ultrasound Surveillance Programs

acronym: FASTRAK

summary:
Intro: Hepatocellular carcinoma (HCC) is the 6th leading cause of cancer worldwide. In France, more than 10,000 new cases are identified each year. The latter occur in 85% of cases in cirrhosis, the most frequent causes of which are excessive alcohol consumption, metabolic syndrome or HBV/HCV infection. Patients with cirrhosis justify being included in monitoring programs involving the performance of a semi-annual liver ultrasound (US) in order to detect HCC eligible for curative treatment (liver resection or percutaneous ablation). This practice is considered to be cost-effective in the event of an annual incidence of HCC> 1.5%. US in this context has a low sensitivity for the detection of HCC at the very early stage and the following observations have been made in the last 20 years:

The rate of patients detected at early stage BCLC 0 is around 30% by ultrasound
The rate of patients included in surveillance programs detected with advanced HCC eligible for palliative treatment is around 20%
Reducing the periodicity of liver ultrasounds from 6 to 3 months does not improve these results.

In parallel, liver MRI has been evaluated as a tool for the early detection of HCC. Its performance for the detection of HCC at the very early stage exceeds 80%. However, due to the higher cost compared to US, it was estimated that its use in screening context would only be cost effective in the event of an annual incidence> 3%. In addition, the practice of these expensive and long-lasting MRIs (30 to 45 minutes) can be optimized by carrying out abbreviated MRI protocols" or Fast-MRI: short protocols (<10 minutes), based on the sequences with the better detection sensitivities (Se> 83%).

The hypothesis is that Fast-MRI used as a screening examination in patients at high risk of HCC (> 3% per year) could increase the rates of patients detected at an early stage accessible to curative treatment and demonstrate its cost-effectiveness in this population.

Hypothesis/Objective: The main objective is to assess the cost / QALY and / patient detected with an early HCC BCLC 0 (single tumor <2cm) by semi-annual monitoring by liver US and Fast-MRI, compared to conventional semi-annual monitoring by liver US alone in patients with cirrhosis and an anticipated HCC incidence>3%.

Conclusion: If positive, this trial could modify international practice guidelines and set MRI as the optimal tool for early HCC detection in high-risk patients.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Screening

location_facility: Assistance Publique Hôpitaux de Paris - Hôpital Avicenne


title: Low Health Literacy Prevalence's Study in Patients Hospitalized a Congestive Heart Failure, a Myocardial Infarct, or a Stroke

acronym: LIT-S

summary:
Health literacy is the ability to access, understand, evaluate and apply information in order to communicate with health professionals and understand health instructions but also, promote, maintain and improve health throughout life. Health literacy (HL) is known as a health determinant.

An association has been shown between low HL and poorer health outcomes such as increased number of unscheduled hospitalisation or emergency visits, low medication adherence and poor health status.

These have been particularly demonstrated with cardiovascular diseases, which combine risk factors (emergency hospitalization, reduction in the length of hospital stays, and complex secondary preventive drug treatments). Despite large scientific international literature about HL and health outcomes, no information is available in France on the prevalence of low HL level among patients managed for neuro-cardio-vascular diseases.

It has been shown in other countries that healthcare professionals overestimate the HL level of their patients and do not adapt information to the HL level. Therefore, patients with low HL do not understand and/or are not able to use properly the information they receive.

Having a better knowledge of HL level and characteristics in these patients is necessary to develop tools for helping healthcare professionals to identify patients with low HL level and to realize the role of HL as a determinant of health. It will also provide more precise information on the difficulties or needs of patients with different levels of health literacy.

location_facility: Hôpital pneumologique et cardiovasculaire Louis Pradel, HCL


title: Role of Fluorodeoxyglucose (FDG) PET-CT in the Initial Staging of Breast Cancer (ASAINT 1) and in the Early Assessment of Response to Neoadjuvant Chemotherapy (ASAINT 2)

acronym: ASAINT

summary:
The two main objectives of this prospective study are:

to identify those patients for whom pre-treatment FDG (Fluorodeoxyglucose) PET (positron emission tomography) CT-scan (Computed tomography scan) provides useful information for the treatment of breast cancer (ASAINT 1),
to improve FDG PET-CT-scan imaging criteria for assessing response to neoadjuvant therapy early, in M0-patients (ASAINT 2).

The secondary objective is to better understand the interactions between the imaging parameters of FDG PET-CT-scan and biological and histological features of breast cancer .

This is a non-interventional study. Two PET-CT-scans are performed, one before starting treatment, and the other after 2 cycles of neoadjuvant chemotherapy. The two PET-CT-scans are prescribed by oncologists from the center of breast diseases Unit at St. Louis hospital, in Paris, France. Oncologists provide clear information to the patients on the purpose of the examination. The examinations are performed in the nuclear medicine department at St. Louis hospital. PET-CT-scans data, tumor characteristics, results of other imaging and biological tests, results of surgery and patient's follow-up are summarized in a "de-identified" file. This file has been declared to the National Commission on Informatics and Liberties (CNIL). The data in this file are established prospectively and secondary analyzed to assess the precise role of PET-CT-scans in the initial staging of breast cancer and to determine the optimal PET-CT-scans criteria to evaluate response to neoadjuvant treatment early.


type: EudraCT Number

title: A Randomized, Placebo Controlled, Double Blind, Double Dummy, Multicenter Trial Comparing Electronic Cigarettes With Nicotine to Varenicline and to Electronic Cigarettes Without Nicotine.

acronym: ECSMOKE

summary:
Background:

Electronic cigarettes (EC) mainly containing nicotine (88-95 % of users) are widely and growingly used worldwide. It is estimated that there were 1.7 million daily users in France in 2016. Although the number of publications about its use is increasing exponentially, there are no evidence based, unbiased, head-to-head comparison data about its efficacy as an aid to smoking cessation. As of today, only two head-to-head randomized studies have been published, both reported negative results at the main endpoint but they used first and second generation EC delivering nicotine with low or unknown bioavailability. Recent EC deliver nicotine with largely improved bioavailability.

One of the randomized studies compared EC with and without nicotine to nicotine patch and reported similar smoking cessation rate at main outcome. However, there is no published, double blind study comparing EC use with a well-studied, licensed smoking cessation medication.

Superiority of EC with nicotine compared to EC without nicotine and to a reference smoking cessation medication while collecting also straightforward information about safety, would allow proposing EC with nicotine to the large population of smokers who intend to quit and situate it among the approved smoking cessation treatments.

The clinical study's hypothesis:

EC containing nicotine can be considered as a nicotine replacement therapy having, probably, a better bioavailability of nicotine than the marketed pharmaceutical NRTs, first line medications of smoking cessation. It is therefore of interest to compare EC containing nicotine to EC without nicotine but also to a reference medication with demonstrated efficacy in smoking cessation. We hypothesize that EC with nicotine provides a higher smoking abstinence rate than EC without nicotine and may be as good as varenicline, our reference medication.

ReferenceType: derived

ReferenceCitation: Berlin I, Dautzenberg B, Lehmann B, Palmyre J, Liégey E, De Rycke Y, Tubach F. Randomised, placebo-controlled, double-blind, double-dummy, multicentre trial comparing electronic cigarettes with nicotine to varenicline and to electronic cigarettes without nicotine: the ECSMOKE trial protocol. BMJ Open. 2019 May 24;9(5):e028832. doi: 10.1136/bmjopen-2018-028832.

family: Berlin

full_name: Ivan Berlin

given: Ivan

sequence: first

family: Dautzenberg

full_name: Bertrand Dautzenberg

given: Bertrand

sequence: additional

family: Lehmann

full_name: Blandine Lehmann

given: Blandine

family: Palmyre

full_name: Jessica Palmyre

given: Jessica

family: Liégey

full_name: Emmanuelle Liégey

given: Emmanuelle

family: De Rycke

full_name: Yann De Rycke

given: Yann

family: Tubach

full_name: Florence Tubach

given: Florence

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repository_normalized: HAL

repository_institution: Université de Lausanne - SERVAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central
serval.unil.ch

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal


title: Analysis of Non-vaccination Factors Against Hepatitis B Virus (HBV) in Drug Users Consulting at the Croix-rousse Drug Addict Care Center (Annuaire Centres de Soins, d'Accompagnement et de prévention en Addictologie (CSAPA))

acronym: ANOVAC B

summary:
Hepatitis B is one of the major public health problems in the world. According to World Health Organization (WHO) data, about 2 billion people have been in contact with the hepatitis B virus (HBV), and 257 million have chronic HBV infection.

Although France is a low endemic country, with just over 280,000 people with chronic infection, hepatitis B remains a public health problem due to its morbidity and mortality.

Drug users are a population at risk by their consumption practices (injection or sniffing), but also by other high-risk behaviours, particularly sexual behaviours.

Prevention therefore involves securing consumption practices (sterile and single-use equipment) and protection of sexual intercourse, but also by vaccination (protecting more than 90%).

Since 1982, HAS has recommended to systematically vaccinate drug users. However, according to the Marmottan study published in 2003, immunization coverage among drug addicts was already insufficient in 1999 (45.3%) and decreased again in 2000 and 2001 (15.6 and 21.7%).

This decrease can be explained by the controversy around the potential link, now refuted, between vaccine against HBV and demyelination, which has stopped the mass vaccination campaign launched by the French health authorities in 1995.

A study conducted between 2009 and 2012 on injecting drug users in Alsace, estimated vaccination coverage at 28%.

The hypothesize is that despite the recommendations in a population at high risk of contamination, and a balance of benefits and risks in favor of vaccination, vaccination coverage against the hepatitis B virus remains insufficient among drug users because of poor vaccination acquaintance, and hepatitis B in general, in this population.

Principal objective of this study is to identify non-vaccination factors against hepatitis B virus among drug users consulting at the Croix-Rousse CSAPA.

ipd_sharing: No

location_facility: Hôpital de la Croix-Rousse, 103 grande rue de la Croix-Rousse


title: The Experiences of Family Caregivers of Stroke Patients: A Cross-sectional Study of a French Cohort

acronym: AVCAIDE

summary:
Stroke is the most common cause of non-traumatic disability in adults and ranks second among causes of dementia and third among causes of death. In France, stroke affects around 140,000 patients each year and entails enormous economic costs. Given the average age of onset of stroke, its prevalence is expected to increase with increasing life expectancy and the advancing age of the population.

Clinically, depending on the region of the brain affected, stroke results in a sudden and abrupt onset of sensorimotor, cognitive, emotional and / or behavioral manifestations, associated with variable recovery from patient to patient. Stroke has psychological, social and family consequences. Indeed, its occurrence could affect patients on a physical and psychological level (direct physical and cognitive sequelae of stroke, decrease or even absence of autonomy and dependence of the entourage, associated psychological changes) and generate repercussions on the dynamics. family or that of the couple (ie, changes in activities, redistribution of tasks, changes or even inversion of roles, alteration of the intimate sphere), as well as professional and social life. This could hamper the quality of life of patients and their loved ones and cause collateral damage to their social or family environment.

After discharge from the hospital, the patient's relatives will play a major role in taking charge of home care (e.g. household activities and personal care around hygiene, food, mobility and administration. treatments) as well as in the community (eg purchase of clothes or food, accompaniment to medical visits), although these helpers do not have the professional knowledge and skills in care. Despite the positive effects that caregivers can have in connection with the care they provide (ie, feeling of accomplishment and usefulness, development of a sense linked to this helping role, better self-esteem, improvement of personal skills), their continued investment in their sick relatives could deprive them of their resources, making them "hidden or invisible patients / victims". In addition, the gap between caregiver capacities to provide care and the health needs of patients could result in caregiver burden (i.e., caregiving burden). Caregivers of stroke patients experience an impaired quality of life, neglect of their own health, reduced work and leisure activities, as well as psychological suffering involving feelings of abandonment, loneliness and helplessness. uncertainty. In the context of a stroke, caregivers may be overwhelmed by the emotions of their ill loved ones as well as their own emotions. Emotional regulation is essential in such a context rich in emotional experience; it is the set of strategies that enables individuals to influence the emotions they feel, when they appear, and how they experience and express them.

Reviews of the literature have highlighted the lack of studies addressing the burden on caregivers and the need for research to identify those at risk and implement appropriate interventions.

No French study has specifically addressed the notion of the burden of caregivers of stroke patients, their coping strategies, their experiences or emotional regulations. This type of study would however constitute a step towards the design and implementation of personalized care (eg: psychotherapies), by strengthening effective / adaptive strategies and modifying those which are less effective / poorly adaptive. This could improve the well-being of caregivers and their sick relatives, and direct health policies to reduce the economic impact of this aid.

status: Active, not recruiting

ReferenceType: result

ReferenceCitation: Blake H, Lincoln NB. Factors associated with strain in co-resident spouses of patients following stroke. Clin Rehabil. 2000 Jun;14(3):307-14.

ReferenceCitation: Blake H, Lincoln NB, Clarke DD. Caregiver strain in spouses of stroke patients. Clin Rehabil. 2003 May;17(3):312-7.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_facility: Institut de Psychologie, Université de Paris


title: Identification and Validation of Addictology Expert Patients' Fields of Intervention With Inpatients for Addictive Disorders

acronym: HAPEX

summary:
Although there are many publications concerning the benefit of the interventions of the self-help movements and peer health mediators in psychiatry, no studies have described the intervention specific to patients with expertise in addictology (EP), nor evaluated their effectiveness.

The objective of this study is twofold: identify and define the fields of intervention of EPs adapted to the specific needs of addictology patients. And validate, through a pilot study, the intermediate effectiveness of EP intervention. This EP intervention will be built on the areas of expertise defined in the first step. Intermediate effectiveness will be measured by patients' ability to manage their addiction. The first part of the study will consist of a preliminary qualitative patient-centered study to clarify patients' needs and expectations regarding the content of the EPs' intervention into a one addictology service of the university hospital of Bichat, Paris, France. This will make it possible to translate these needs into fields of expertise to address during the EPs' intervention and will result in the creation of a hetero-questionnaire. The second part of the study will consist of a before-and-after comparative study on inpatients who are their own controls based on the hetero-questionnaire constructed through the qualitative study.

This study will identify the main EP's intervention fields in addictology in which EP are more relevant to patients. Thus, their inpatient interventions can be validated and improved, and better carried by addiction professionals.

location_facility: Département psychiatrie et addictologie Bichat Claude Bernard

intervention_type: Behavioral


title: EFFICACY OF THE SLEEVE GASTROPLASTY WITH THE ENDOSCOPIC SYSTEM OVERSTICH SX ON WEIGHT LOSS AND REDUCTION OF CO-MORBIDITY FOR OBESE PATIENTS

acronym: SLEEVE

summary:
The OverStitch ™ Sx System (Apollo Endosurgery Inc., Austin, Tx, Usa) is a new generation of endoscopic suturing device. It is inserted into an endoscope allowing the approximation of Luc Karsentys soft tissue by placement of sutures. It is as effective a suture system as a surgical system. The OverStitch ™ Sx allows suturing in the upper and lower GI with a flexible single channel endoscope. Previously, the ™ Overstich was only compatible with an Olympus dual channel endoscope.

Thus, a wide range of interventions are possible, including gastric endoplastic sleeve (ESG), RYGB revision, anastomotic fistula repair and / or sleeve revision. In each of these indications, the OverStitch (OverStitch) ™ system has shown its effectiveness and safety.

The OverStitch Endoscopic ™ Suture System allows the entire digestive wall to be sutured through a flexible endoscope. Thus, a wide range of interventions are possible, including gastric pocket repair after gastric bypass surgery, anastomotic fistula repair, endoscopic treatment of digestive perforation, and endoscopic sleeve surgery. In each of these indications, the OverStitch system has demonstrated its effectiveness and safety. But this technique is recent, especially in France. In addition, no data has yet been released regarding the new Overstitch ™ Sx device compatible with all single channel endoscopes.

An observational study including patients in French centers that are experts in therapeutic endoscopy seems essential to us to better assess this new device and this new technique in practice

primary_purpose: Other

lead_sponsor: Clinique du Trocadéro

intervention_type: Procedure


title: Quantification of Dopamine Active Transporter (DAT) in Humans: Validation of a New Radiophamaceutical, the [18F] LBT-999

acronym: LBT 999

summary:
Idiopathic Parkinson's disease (IPD) is a degenerative disease affecting the dopaminergic system. Clinical symptoms of IPD commonly begin after the loss of at least 40 to 50% of striatal dopaminergic terminals (specially putaminal terminals).

The Dopamine neuronal transporter (DAT) is a highly expressed protein in the membrane of presynaptic nigrostriatal dopaminergic terminals. The use of a DAT's radioligand in the initial stages of the disease would lead to an early detection of nigral cell loss.

Currently, only one DAT's radioligand has obtained marketing authorization in France, the 123I-FPCIT, for use in Single Photon Emission Computed Tomography (SPECT).

Otherwise, the Positron Emission Tomography (PET), a more sensitive technology than SPECT with higher resolution has become for a few years the new gold standard for visual analysis and quantification of neurotransmission systems (including the dopaminergic system).

A DAT tracer labelled with Carbon 11 ([11C] PE2l) have been developed and is currently used as a reference in various research centers.

However, in order to enable a clinical use of this tracer (which currently can't be because of the too short period of Carbon 11), the unit INSERM U930 "Imaging and Brain" in collaboration with the CERRP (Center for Studies and Research on Radiopharmaceuticals) developed a new version of this tracer, labelled with 18-fluor: the [18F] LBT-999.

The main goal of this study is to compare the [18F] LBT-999 uptake between a group of patients suffering from a Parkinsonien syndrome to a group healthy volunteers.

status: Terminated

primary_purpose: Diagnostic

ReferenceCitation: Agid Y. Parkinson's disease: pathophysiology. Lancet. 1991 Jun 1;337(8753):1321-4. Review.

ReferenceCitation: Brooks DJ, Pavese N. Imaging biomarkers in Parkinson's disease. Prog Neurobiol. 2011 Dec;95(4):614-28. doi: 10.1016/j.pneurobio.2011.08.009. Epub 2011 Aug 30. Review.

ReferenceCitation: Brooks DJ. Imaging dopamine transporters in Parkinson's disease. Biomark Med. 2010 Oct;4(5):651-60. doi: 10.2217/bmm.10.86. Review.

ReferenceCitation: Chalon S, Hall H, Saba W, Garreau L, Dollé F, Halldin C, Emond P, Bottlaender M, Deloye JB, Helfenbein J, Madelmont JC, Bodard S, Mincheva Z, Besnard JC, Guilloteau D. Pharmacological characterization of (E)-N-(4-fluorobut-2-enyl)-2beta-carbomethoxy-3beta-(4'-tolyl)nortropane (LBT-999) as a highly promising fluorinated ligand for the dopamine transporter. J Pharmacol Exp Ther. 2006 Apr;317(1):147-52. Epub 2005 Dec 9.

ReferenceCitation: de Rijk MC, Tzourio C, Breteler MM, Dartigues JF, Amaducci L, Lopez-Pousa S, Manubens-Bertran JM, Alpérovitch A, Rocca WA. Prevalence of parkinsonism and Parkinson's disease in Europe: the EUROPARKINSON Collaborative Study. European Community Concerted Action on the Epidemiology of Parkinson's disease. J Neurol Neurosurg Psychiatry. 1997 Jan;62(1):10-5.

ReferenceCitation: Fernagut PO, Li Q, Dovero S, Chan P, Wu T, Ravenscroft P, Hill M, Chen Z, Bezard E. Dopamine transporter binding is unaffected by L-DOPA administration in normal and MPTP-treated monkeys. PLoS One. 2010 Nov 22;5(11):e14053. doi: 10.1371/journal.pone.0014053.

ReferenceCitation: Hsiao IT, Weng YH, Lin WY, Hsieh CJ, Wey SP, Yen TC, Kung MP, Lu CS, Lin KJ. Comparison of 99mTc-TRODAT-1 SPECT and 18 F-AV-133 PET imaging in healthy controls and Parkinson's disease patients. Nucl Med Biol. 2014 Apr;41(4):322-9. doi: 10.1016/j.nucmedbio.2013.12.017. Epub 2014 Jan 10.

ReferenceCitation: Sérrière S, Tauber C, Vercouillie J, Guilloteau D, Deloye JB, Garreau L, Galineau L, Chalon S. In vivo PET quantification of the dopamine transporter in rat brain with [¹⁸F]LBT-999. Nucl Med Biol. 2014 Jan;41(1):106-13. doi: 10.1016/j.nucmedbio.2013.09.007. Epub 2013 Oct 8.

ReferenceCitation: Schillaci O, Pierantozzi M, Filippi L, Manni C, Brusa L, Danieli R, Bernardi G, Simonetti G, Stanzione P. The effect of levodopa therapy on dopamine transporter SPECT imaging with( 123)I-FP-CIT in patients with Parkinson's disease. Eur J Nucl Med Mol Imaging. 2005 Dec;32(12):1452-6. Epub 2005 Sep 8.

ReferenceCitation: Sharma S, Moon CS, Khogali A, Haidous A, Chabenne A, Ojo C, Jelebinkov M, Kurdi Y, Ebadi M. Biomarkers in Parkinson's disease (recent update). Neurochem Int. 2013 Sep;63(3):201-29. doi: 10.1016/j.neuint.2013.06.005. Epub 2013 Jun 19. Review.

ReferenceCitation: Snow BJ, Tooyama I, McGeer EG, Yamada T, Calne DB, Takahashi H, Kimura H. Human positron emission tomographic [18F]fluorodopa studies correlate with dopamine cell counts and levels. Ann Neurol. 1993 Sep;34(3):324-30.

ReferenceCitation: Varrone A, Stepanov V, Nakao R, Tóth M, Gulyás B, Emond P, Deloye JB, Vercouillie J, Stabin MG, Jonsson C, Guilloteau D, Halldin C. Imaging of the striatal and extrastriatal dopamine transporter with (18)F-LBT-999: quantification, biodistribution, and radiation dosimetry in nonhuman primates. J Nucl Med. 2011 Aug;52(8):1313-21. doi: 10.2967/jnumed.111.089953. Epub 2011 Jul 15.

lead_sponsor: University Hospital, Tours


title: Comparison of the Efficacy and Tolerance of Triple Therapy Guided by the PCR Detection of Clarithromycin Resistance WITH Empiric Concomitant Quadruple Therapy for Helicobacter Pylori Infection: a Randomised Multicentre Trial

acronym: Hepysé

summary:
The H pylori infection remains a public health problem. The eradication rate with the first line triple therapy (PPI-amoxicillin-clarithromycin) is insufficient (estimated at 70%) due to the frequency of resistance to clarithromycin, which reaches 21% in France. Until now,European and French consensus recomended tofavor sequential therapy (5 days PPI-amoxicillin and 5 days PPI-clarithromycin-metronidazole) or quadruple bismuth therapy ( 10 days PPI-tetracyclin,-metronidazole- bismuth). Studies in countries with low prevalence of clarithromycin resistance reported eradication rate of 85% with sequential therapy and reported a low impact of clarithromycin resistance on the effectiveness of this treatment. However, recent studies suggest a greater impact of clarithromycin resistance. Recent meta-analysis shows that empiric sequential therapy is less efficacious than concomitant quadruple therapy. Therefore, recent Maastricht V / Florence meeting October 7-8 2015) recommended to abandon sequential therapy and to favor 14 days concomitant therapy in first line in order to reach an eradication rate >90%.

In a multicenter randomized clinical trial (HELICOSTIC 2010-2011 AO ICST 2009), we compared a triple therapy guided by the results of a PCR test that detects resistance to clarithromycin and levofloxacin (HelicoDR ®) to empirical triple therapy (PPI-amoxicillin-clarithromycin). 1384 patients and among them 526 infected patients were enrolled in 10 centers. The results in 415 patients were 73.1% for the empirical treatment versus 85.5% (p <0.001) for the treatment guided by PCR HelicoDR®. This study also demonstrated the limits of the test HelicoDR®: onerous, possibility of contamination, little practical contribution of the determination of resistance to quinolones.

Moreover, it has been shown that triple therapy efficiency could be optimized by increasing duration up to 14 days and increasing dose of PPI to 40mg b.d;.and eradications rates > 90% were reported with susceptible to clarithromycin strains.

Adverse events are less common with optimized triple therapy than with concomitant quadruple therapy.

The main objective is to compare the efficacy of optimized triple therapy guided by the results of a PCR test (eradication rates 90% hypothesized) with quadruple concomitant therapy (eradication rate 90% hypothesized).

The secondary objective is to determine side effects of optimized guided triple therapy as well as the quadruple concomitant therapy in France.


type: Registry Identifier

title: PREVALENCE STUDY OF FIBROMUSCULAR DYSPLASIA IN PATIENTS WITH HAEMATOMA OR SPONTANEOUS CORONARY ARTERY DISSECTION

acronym: DISCO

summary:
Spontaneous Coronary Artery Dissection (SCAD) is a rare and often misdiagnosed cause of Acute Coronary Syndrome (ACS) affecting predominantly young women without cardiovascular risk factors. The origin of SCAD remains uncertain but a strong and frequent association with Fibromuscular Dysplasia (FMD) has been recently reported based on imaging evidence only.

The aim of our study is to assess the presence of FMD and its genetic determinants i in a sample for haematoma or spontaneous coronary artery dissection.

From May 2016 to 2018 we plan to include prospectively and retrospectively 200 patients admitted for ACS with confirmed diagnosis of SCAD. This study will be conducted in more than 30 French interventional cardiology centers. Coronary angiograms or intracoronary imaging data will be reviewed by two experienced interventional cardiologist experts in SCAD diagnosis.

For each patient a genetic analysis will be performed. A systematic screening for FMD will be realized by computed tomographic or MRI angiography of renal, cerebrovascular and iliac arteries and reviewed by two experienced radiologists. A one year follow-up is expected.

This study aims to confirm the presumed association of FMD and SCAD through the exploration of several artery beds and the study of confirmed genetic determinants, which has never been described previously to our knowledge.


title: Impact of a Telemonitoring Program on the Rate of Hospitalizations for Worsening of Cardio-respiratory Symptoms in COPD Patients Treated at Home by Long-term Non-invasive Ventilation (NIV): a Randomized Controlled Trial

summary:
COPD is characterized by non-reversible chronic airway obstruction. Its evolution is punctuated by successive exacerbations precipitating the progression of the disease and its co-morbidities. The most severe exacerbations are the source of frequent hospitalizations that strongly affect the patient's quality of life and are associated with increased mortality. The diagnosis of exacerbation is mainly clinical but patients frequently consult their doctor too late which may lead to delays in care. However, the early detection and management of these exacerbations can reduce their impact and in particular avoid hospitalization or shorten their duration.

In France, long term Non-Invasive Ventilation (NIV) is a widely used treatment modality in COPD patients with chronic alveolar hypoventilation who have frequent exacerbations. The investigators have demonstrated in a previous study that the analysis of parameters from software embedded in the NIV device can reliably predict the occurrence of an exacerbation. The investigators hypothesize that the daily transmission via a telemonitoring platform of the ventilation parameters of patients, together with an ad hoc warning system, would reduce the rate of hospitalization for COPD patients treated at home with NIV thanks to the early detection and early treatment of these exacerbations.

The purpose of the study is to compare if a program of telemonitoring using the parameters stored by the NIV impact the rate of hospitalization for worsening of cardiorespiratory symptoms in COPD patients versus standard care over a one year period.


title: The CINSARC Genomic Signature as a Predictor of Resectability of High Grade Serous Ovarian Adenocarcinomas

acronym: OVASARC

summary:
The majority of primary cancers of the ovary or peritoneum are represented by high-grade serous adenocarcinomas. These are rare pathologies, the incidence of which is estimated at 7.1 per 100,000, representing approximately 4,500 new cases per year in France (INCA 2017). In the absence of effective screening, nearly 85% of patients have an advanced disease at diagnosis (corresponding to the FIGO III or IVA stage, characterized by diffuse peritoneal involvement). Despite multidisciplinary care, the majority of patients (80%) will recur within a median of 18 to 24 months.

It is therefore necessary to develop new tools, in particular molecular, in order to allow :

to better select patients accessible to full interval surgery
to exclude patients who would not benefit from this surgery in terms of survival

In 2010, Chibon et al. identified, from a cohort of patients with soft tissue sarcoma (STM), a molecular signature (called CINSARC), based on the expression profile of 67 genes involved in mitotic control and chromosomal integrity. The team showed that this transcriptomic signature is an independent prognostic factor in different types of STM, but also a prognostic factor more discriminating than the histological grade (FNCLCC), historical and major prognostic factor of STM.

Being initially made from frozen material and on a DNA biochip (Affymetrix), this signature was unusable outside the field of fundamental research. This is why CINSARC has been gradually optimized, first by the RNA sequencing technique on frozen tissue fixed in formalin (FFPE), and recently on FFPE tissue by the NanoString® technique. This very sensitive and inexpensive technique requires only small amounts of total RNA, making it compatible with use on "routine" diagnostic samples, microbiopsy or surgical biopsy, opening the door to real clinical application. Several clinical studies using this latest CINSARC optimization (called NanoCind®) to determine the treatment of patients with STM will also begin soon.

As a result of this work, necessary in order to more precisely support the potential of CINSARC in this pathology, the investigators hope to be able to assess from the diagnosis the evolutionary potential of the patients, which could make it possible to evaluate therapeutic strategies adapted to the profiles of each subpopulation: the investigators can for example imagine in theory a therapeutic de-escalation for low-risk patients, or else, for very high-risk patients, an intensified strategy.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Claudius Regaud Institut Universitaire du cancer Toulouse Oncopole


title: Evaluation of the Incidence of Chronic Post-cesarean Pain as Part of an Enhanced Recovery After Surgery (ERAS) Protocol.

acronym: ChroCéRAAC

summary:
Enhanced Rehabilitation After Surgery (ERAS), developed in the 1990s, is a program encompassing a set of measures before, during and after surgery aimed at improving management by promoting the early recovery of the patient's abilities after surgery.

The ERAS has been scientifically validated and standardized in many surgical disciplines since the implementation of guidelines in France in 2016.

Regarding the obstetrical field, it was not until 2018 that the caesarean section could benefit from ERAS, with the publication of specific guidelines.

Several studies have been able to demonstrate ERAS effectiveness in reducing the length of hospitalization, postoperative complications, the consumption of analgesics immediately after surgery, and the financial cost, including in the context of cesarean sections.

But beyond immediate benefit, the impact of an ERAS protocol on chronic pain has not yet been evaluated.

Chronic pain is defined as physical discomfort that persists for more than 2 months after surgery.

It was not until 2004 that research focused on chronic post-cesarean pain, finding an incidence of chronic pain of 18.6% at 3 months and 12.3% at 6 months. In 2016, another study estimated an incidence of chronic pain in the caesarean scar at 15% at 3 months and 11% at 1 year. The investigators can notice that the presence of chronic post-cesarean pain remained stable over this period.

Several risk factors have been identified, such as the presence of acute pain immediately after surgery, the type of anesthesia, the type of surgical incision or a significant state of anxiety before the operation.

In this context, the investigators wish to assess the rate of chronic post-surgical pain in scheduled cesarean sections (excluding emergencies) under spinal anesthesia as part of a ERAS protocol. The investigatrors will also specify the type of pain and its impact on the daily activities of young mothers and will assess the level of adherence of medical and paramedical teams to the ERAS protocol.

To answer these questions, the investigators will conduct a telephone survey with a questionnaire to assess pain at 3 months and then 6 months after their cesarean section. The pain studied is defined as being the pain at the level of the caesarean scar.

This is an innovative subject evaluating the impact of the implementation of an ERAS protocol on chronic pain. Depending on the results, the investigators will be able to optimize the prevention of chronic pain of cesarean section.

ReferenceCitation: Nikolajsen L, Sørensen HC, Jensen TS, Kehlet H. Chronic pain following Caesarean section. Acta Anaesthesiol Scand. 2004 Jan;48(1):111-6.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer


title: Multi-centre Prospective Cohort of Childhood Leukaemia: Determinants of Health and Quality of Life of the Patients After Treatment for an Acute Leukaemia During Childhood or Adolescence - LEA

summary: Regular advances in cancer treatment have dramatically improved the prognosis of children and adolescents with acute leukemia (AL), raising with a great acuity the problem of the late physical side effects, social integration, quality of life of the patients and their family as well as identification of the determinants of these outcomes. Large nationwide and international cohorts developed in general population (I4C, EPIC ELF…) are restricted to the study of childhood cancers occurrence. In addition, the national registries (French, European) of childhood cancers are designed to evaluate incidence and mortality, but not to produce individual detailed data on the follow-up and outcome of these children. Answering these questions supposes a comprehensive multidisciplinary approach resting on prospective cohorts of cancer survivors, specifically exploring the outcome of these children. These cohorts allow to identify prognostic factors of the health condition and social integration, and to propose adapted strategies of follow-up. The Childhood Cancer Survivor Study (CCSS), which remains the most important study, only concerns the North-American populations and rests on a self-reported follow-up assessment. In France, the LEA study, initiated in 2004 could answer some of these questions, but the representativeness and the size of the population (study initially limited to two areas PACA-Corsica and Lorraine) remain insufficient to study uncommon events. Similar approaches are conducted in Europe trough the broad collaborative Pancare network, to which the LEA program is associated.

ReferenceCitation: Oudin C, Berbis J, Bertrand Y, Vercasson C, Thomas F, Chastagner P, Ducassou S, Kanold J, Tabone MD, Paillard C, Poirée M, Plantaz D, Dalle JH, Gandemer V, Thouvenin S, Sirvent N, Saultier P, Béliard S, Leverger G, Baruchel A, Auquier P, Pannier B, Michel G. Prevalence and characteristics of metabolic syndrome in adults from the French childhood leukemia survivors' cohort: a comparison with controls from the French population. Haematologica. 2018 Apr;103(4):645-654. doi: 10.3324/haematol.2017.176123. Epub 2018 Jan 19.

family: Oudin

full_name: Claire Oudin

given: Claire

family: Berbis

full_name: Julie Berbis

given: Julie

family: Bertrand

full_name: Yves Bertrand

given: Yves

family: Vercasson

full_name: Camille Vercasson

given: Camille

family: Thomas

full_name: Frédérique Thomas

given: Frédérique

family: Chastagner

full_name: Pascal Chastagner

given: Pascal

family: Ducassou

full_name: Stéphane Ducassou

given: Stéphane

family: Kanold

full_name: Justyna Kanold

given: Justyna

family: Tabone

full_name: Marie-Dominique Tabone

given: Marie-Dominique

family: Paillard

full_name: Catherine Paillard

given: Catherine

family: Poirée

full_name: Marilyne Poirée

given: Marilyne

family: Plantaz

full_name: Dominique Plantaz

given: Dominique

family: Dalle

full_name: Jean-Hugues Dalle

given: Jean-Hugues

family: Gandemer

full_name: Virginie Gandemer

given: Virginie

family: Thouvenin

full_name: Sandrine Thouvenin

given: Sandrine

family: Sirvent

full_name: Nicolas Sirvent

given: Nicolas

family: Saultier

full_name: Paul Saultier

given: Paul

family: Béliard

full_name: Sophie Béliard

given: Sophie

family: Leverger

full_name: Guy Leverger

given: Guy

family: Baruchel

full_name: André Baruchel

given: André

family: Auquier

full_name: Pascal Auquier

family: Pannier

full_name: Bruno Pannier

given: Bruno

family: Michel

full_name: Gérard Michel

given: Gérard

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - SHS

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Bretagne Occidentale

publisher: Ferrata Storti Foundation (Haematologica)

title: Prevalence and characteristics of metabolic syndrome in adults from the French childhood leukemia survivors’ cohort: a comparison with controls from the French population

ReferenceCitation: Saultier P, Auquier P, Bertrand Y, Vercasson C, Oudin C, Contet A, Plantaz D, Poirée M, Ducassou S, Kanold J, Tabone MD, Dalle JH, Lutz P, Gandemer V, Sirvent N, Thouvenin S, Berbis J, Chambost H, Baruchel A, Leverger G, Michel G. Metabolic syndrome in long-term survivors of childhood acute leukemia treated without hematopoietic stem cell transplantation: an L.E.A. study. Haematologica. 2016 Dec;101(12):1603-1610. Epub 2016 Aug 11.

ReferenceCitation: Oudin C, Auquier P, Bertrand Y, Chastagner P, Kanold J, Poirée M, Thouvenin S, Ducassou S, Plantaz D, Tabone MD, Dalle JH, Gandemer V, Lutz P, Sirvent A, Villes V, Barlogis V, Baruchel A, Leverger G, Berbis J, Michel G. Late thyroid complications in survivors of childhood acute leukemia. An L.E.A. study. Haematologica. 2016 Jun;101(6):747-56. doi: 10.3324/haematol.2015.140053. Epub 2016 Mar 11.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Efficacy and Tolerance of RHEOpheresis in the Treatment of Peripheral Artery Disease in Hemodialysis Patients: a Prospective Randomized Single-blind Trial

acronym: RHEO-PAD

summary:
Peripheral arterial disease (PAD) with limb-threatening ischemia (PAD-LTI) involves both macrocirculation and microcirculation. Macrocirculatory abnormalities are accessible to revascularization techniques (endovascular or surgical) contrary to microcirculatory abnormalities. Conservative treatments have limited efficacy in patients with end-stage renal disease (ESRD). There is no alternative treatment for patients with PAD-LTI in hemodialysis.

Rheopheresis is an apheresis technique specifically designed for the treatment of microcirculatory disorders in which anomalies of rheology are at the center of physiopathology. This double cascade plasma filtration technique reduces plasma viscosity and eliminates inflammation mediators which play an essential role in PAD. This technique has already shown its effectiveness in a randomized trial in dry Age-related macular degeneration (AMD), another pathology of microcirculation. The effectiveness of rheopheresis in PAD-LTI has only been reported in a small number of cases.

This Hypothesis is that the treatment of microcirculation by rheopheresis would improve wound healing of the ischemic lesion and/or reduce major amputation and thus the prognosis of the affected limb of the patient with PAD-LTI in hemodialysis. This objective is to demonstrate the efficacy of rheopheresis, (twelve sessions), to avoid major amputation and reaches complete wound healing of ischemic lesion in the dialysis patient population with PAD-LTI. This study is prospective, Controlled, Parallel, Randomized, Single blind and Multicentric in France (12 French centers).

location_facility: Assistance Publique Hôpitaux de Marseille


title: Added Value of Supersonic Shear Imaging in the Diagnosis of White Matter Damage in Preterm Infants

acronym: BELUGA

summary:
Preterm birth and perinatal events related can interrupt microscopic maturation of the developing white matter leading to diffuse injury and subsequent neurocognitive impairments. Brain maturation can be studied using diffusion tensor imaging but is difficult to assess early after birth, repeatedly and at the bedside. Supersonic Shear wave Imaging (SSI) could be of interest in this clinical setting. This technique, already investigated in adults (breast, thyroid or liver fibrosis staging), has not been yet evaluated in neonates.

Objective:

To describe the feasibility and reproducibility of quantitative elasticity mapping in preterm infants and to correlate to gestational age.

Methods:

SSI is a quantitative stiffness imaging technique based on the combination of a remote palpation induced into tissues by the radiation force a focused ultrasonic beam and an ultrafast ultrasound imaging sequence. Such ultrafast frame rates permit to track in real time the displacements induced by the propagation of the resulting shear waves. For each pixel, the shear wave speed can be estimated locally and enables quantitative mapping of the local shear elasticity (characterizing the stiffness in kPa). In this study, we will use a new generation of ultrafast ultrasound scanners (Aixplorer®, Supersonic Imagine, Aix en Provence, France) with a linear L10-2 probe (256 elements, 6 MHz) in neonates born between 25 and 40 weeks' gestation (n=100). Three separate acquisitions will be obtained for each area of interest both on right and left sides and stiffness was measured using a unique ROI of 2.5 cm².


title: Randomized Trial Comparing the Efficacy of Chlorambucil to Fludarabine in Patients With Advanced Waldenström Macroglobulinemia,Lymphoplasmacytic Lymphoma or Splenic Marginal Zone Lymphoma

summary:
Waldenström's macroglobulinaemia (WM) is a lymphoproliferative disorder characterized by a monoclonal IgM paraprotein and morphological evidence of lymphoplasmacytic lymphoma: the cells are IgM+, IgD+, CD19+ and CD20+ but usually CD5-, CD10- and CD23-. The treatment efficacy is difficult to assess because of the lack of clear diagnostic criteria , good response criteria, and of randomized trials.

The actual treatment is Chlorambucil, an alkylating agent. A purine analogue such as Fludarabine has proven its efficacy on 30 % to 80 % as first line therapy

This study is a phase II b open, prospective, international multicenter trial (England, Dr Johnson, Dr Catovsky, Australia: Dr Seymour) promoted by the French Cooperative Group on Chronic Lymphoid Leukemia in untreated WM, or closely related disorders ( Lymphoplasmacytic lymphoma or splenic marginal zone lymphoma). 366 patients must be included, among them 180 patients in France. Patients will be stratified according to the lymphoproliferative disorder.

The patients will receive Chlorambucil by oral route for 10 days every 28 days (12 cycles) (8 MG/M², 6 MG/M² if patient is more than 75 years old) or Fludarabine by oral route for 5 days every 28 days (6 cycles) (40MG/M², 30 MG/M² if patient is more than 75 years old).

The primary objective is to compare the efficacy (response rate) of Chlorambucil to Fludarabine in previously untreated patients. The secondary objectives are the duration of response, the improvement of hematological parameters, the toxicity, the quality of life, the event free survival and the overall survival.

ReferenceCitation: Leblond V, Johnson S, Chevret S, Copplestone A, Rule S, Tournilhac O, Seymour JF, Patmore RD, Wright D, Morel P, Dilhuydy MS, Willoughby S, Dartigeas C, Malphettes M, Royer B, Ewings M, Pratt G, Lejeune J, Nguyen-Khac F, Choquet S, Owen RG. Results of a randomized trial of chlorambucil versus fludarabine for patients with untreated Waldenström macroglobulinemia, marginal zone lymphoma, or lymphoplasmacytic lymphoma. J Clin Oncol. 2013 Jan 20;31(3):301-7. doi: 10.1200/JCO.2012.44.7920. Epub 2012 Dec 10.

name: Véronique Leblond, Florence Nguyen-Khac, and Sylvain Choquet, Hôpital Pitié-Salpêtriere, Assistance Publique-Hopitaux de Paris (AP-HP), Université Paris 6; Sylvie Chevret, Marion Malphettes, and Julie Lejeune, Hôpital Saint-Louis, AP-HP, Paris; Olivier Tournilhac, Hôpital Universitaire Estaing, Clermont-Ferrand Université Auvergne, Clermont-Ferrand; Pierre Morel, Hopital Schaffner, Lens; Marie-Sarah Dilhuydy, Centre Hospitalier Universitaire (CHU) Haut Lévêque, Bordeaux; Caroline Dartigeas, CHU de Tours,...

family: Leblond

full_name: Véronique Leblond

given: Véronique

family: Johnson

full_name: Steve Johnson

given: Steve

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

family: Copplestone

full_name: Adrian Copplestone

given: Adrian

family: Rule

full_name: Simon Rule

given: Simon

family: Tournilhac

full_name: Olivier Tournilhac

given: Olivier

family: Seymour

full_name: John Francis Seymour

given: John Francis

family: Patmore

full_name: Russell D. Patmore

given: Russell D.

family: Wright

full_name: David Wright

given: David

family: Morel

full_name: Pierre Morel

given: Pierre

family: Dilhuydy

full_name: Marie-Sarah Dilhuydy

given: Marie-Sarah

family: Willoughby

full_name: Sara Willoughby

given: Sara

family: Dartigeas

full_name: Caroline Dartigeas

given: Caroline

family: Malphettes

full_name: Marion Malphettes

given: Marion

family: Royer

full_name: Bruno Royer

family: Ewings

full_name: Maeve Ewings

given: Maeve

family: Pratt

full_name: Guy Pratt

family: Lejeune

full_name: Julie Lejeune

given: Julie

family: Nguyen-Khac

full_name: Florence Nguyen-Khac

given: Florence

family: Choquet

full_name: Sylvain Choquet

given: Sylvain

family: Owen

full_name: Roger G. Owen

given: Roger G.

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Results of a Randomized Trial of Chlorambucil Versus Fludarabine for Patients With Untreated Waldenström Macroglobulinemia, Marginal Zone Lymphoma, or Lymphoplasmacytic Lymphoma

ReferenceCitation: Nguyen-Khac F, Lambert J, Chapiro E, Grelier A, Mould S, Barin C, Daudignon A, Gachard N, Struski S, Henry C, Penther D, Mossafa H, Andrieux J, Eclache V, Bilhou-Nabera C, Luquet I, Terre C, Baranger L, Mugneret F, Chiesa J, Mozziconacci MJ, Callet-Bauchu E, Veronese L, Blons H, Owen R, Lejeune J, Chevret S, Merle-Beral H, Leblondon V; Groupe Français d'Etude de la Leucémie Lymphoïde Chronique et Maladie de Waldenström (GFCLL/MW); Groupe Ouest-Est d'étude des Leucémie Aiguës et Autres Maladies du Sang (GOELAMS); Groupe d'Etude des Lymphomes de l'Adulte (GELA). Chromosomal aberrations and their prognostic value in a series of 174 untreated patients with Waldenström's macroglobulinemia. Haematologica. 2013 Apr;98(4):649-54. doi: 10.3324/haematol.2012.070458. Epub 2012 Oct 12.

full_name: F. Nguyen-Khac

given: F.

name: on behalf of the Groupe Francais d'Etude de la Leucemie Lymphoide Chronique et Maladie de WaldenstromGroupe Francais d'Etude (GFCLL/MW) Sang Groupe Ouest-Est d'etude des Leucemie Aigues et Autres Maladies du and de l'Adulte (GOELAMS) Groupe d'Etude des Ly

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

title: Chromosomal aberrations and their prognostic value in a series of 174 untreated patients with Waldenstrom's macroglobulinemia

lead_sponsor: French Study Group on Chronic Lymphoid Leukemia

location_facility: Hôpital La Pitié-Salpêtrière. 47-83 Bd de l'hôpital


acronym: PARTOSURE-OI

summary:
Prematurity is the leading cause of mortality and perinatal morbidity. Despite the many preventive measures and use of tocolytic therapy, the incidence of premature births has not decreased in recent decades. In 2010 the preterm birth rate (single child, born alive) was still 5.5% in France and 11% in the population of Reunion. In 50% of cases, premature birth is related to spontaneous premature labor layout without rupture of amniotic membranes, called threat of premature birth.The threat of premature birth, defined by the combination of cervical modifications and regular and painful uterine contractions from 22 weeks of amenorrhea and 36 weeks of amenorrhea + 6days, is the major cause of hospitalization in pathological pregnancies services. But all threat of premature delivery situations do not cause premature delivery. In our service, only 30% of patients hospitalized for threat of premature delivery give birth prematurely in accordance with published international data. The diagnosis of threat of premature delivery is difficult and it is still not possible to differentiate a "false labour" of a "real labour".

Currently the diagnosis of threat of premature delivery in routine is based on the combination of vaginal examination, the ultrasound, cervical length, but this strategy lacks specificity.

In absence of prognostic tool for predicting more reliably the risk of premature delivery in situation of threat of premature delivery, the medical cares are maximalist.: hospitalization, conducting paraclinical investigations, prescription of tocolytics treatments and conducting antenatal corticotherapy. it seems particularly necessary to identify more efficient prognostic criteria that the clinic and ultrasound for judging the severity of threat of premature delivery in other words to predict the risk of premature delivery to adapt and adjust the care of patients after diagnosis of threat of premature delivery.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

intervention_type: Device


title: Lung Transplantation for Pleuroparenchymal Fibroelastosis : a French Multicentric Retrospective Study

summary: This retrospective observational study will evaluate the outcomes of lung transplantation for a rare cause of interstitial lung disease called pleuroparenchymal fibroelastosis. Data will be collected from all transplantation center in France.

lead_sponsor: Hospices Civils de Lyon

location_facility:
Hopital Louis Pradel
Bichat Claude Bernard Hospital, APHP
Marie Lannelongue Hospital
Foch Hospital


title: Clinical Phenotyping and Characterization of Neural Networks and Cognitive Processes Involved in Mental Retardation X-linked

acronym: XLMR

summary:
X-linked Mental retardation (XLMR) represent 10% of the causes of mental retardation with a prevalence in both sexes around 1/296, i.e. 3.3 / 1000 births (Opitz et al., 1986). This heterogeneous group of XLMR includes dozens of rare diseases, some of them affecting only a few patients. Molecular diagnosis is currently available in France for 25 XLMR genes, within the national network of XLMR molecular diagnosis. However, whereas some syndromes such as Fragile X syndrome, are now well clinically defined, this is not the case for recently identified syndromes for which very few data is available, preventing clinicians to focus molecular diagnosis on a specific gene.

Therefore, this study aims to :

Achieve a description of the clinical phenotype specific to each XLMR gene (Phase 1 of the study, n=200)
Characterize the cognitive learning mechanisms and dysfunctional neural networks involved (Phase 2 of the study, n=75, i.e. 5 groups of 15 patients with a mutation in the same gene). These two elements constitute key steps to develop appropriate rehabilitation strategies and targeted pharmacological therapies.

Moreover, the impact of mental retardation on the primary caregiver within the family and the induced burden in terms of psycho-social, organizational and economic burden will also be assessed. These elements, directly related to the patient's environment, are very important to characterize in order to better understand the consequences of each gene mutation (Phase 3 of the study, n=283). For example, it is necessary to better understand the impact of Fragile X syndrome in terms of capacity and behavior, lifestyle, and health care needs of the patients While advancing knowledge allows to consider innovative therapeutics, the implementation of these therapeutics and assessment of their impact on the patients' life trajectory, require precise characterization of the population to be treated in medico socioeconomic terms.

location_facility: Groupement Hospitalier Est - Hôpital Femme Mère Enfant - Service de neurologie pédiatrique


title: Evaluation of Safety and Efficacy of the FRED and FRED JR Devices for Intracranial Aneurysm Treatment

summary: A French, multicenter, prospective, observational, "real-world" assessment of the safety and efficacy of FRED and FRED Jr devices in the treatment of intracranial aneurysms

lead_sponsor: Microvention-Terumo, Inc.


title: Time to Surgery and Survival Outcomes for Patients With Resected Colorectal Carcinoma: Multicenter Study (BIG RENAPE)

acronym: DELARC

summary:
Colorectal cancer (CRC) is diagnosed in one million patients each year worldwide and is the 2nd leading cause of cancer death. Peritoneal metastasis (MP) is seen in 10% of CRC patients and is the metastatic site with the worst prognosis.

Complete cytoreduction surgery (CCS) is the only treatment that allows for prolonged survivals. Five-year overall survival (OS) after CCS ranges from 30% to 60% compared with 0 to 5% with exclusive medical treatment.

Chemotherapy (CT) with fluoropyrimidine and oxaliplatin and/or irinotecan 3 months pre-operatively and 3 months adjuvant is widely used. The benefits of perioperative CT have been demonstrated in another resectable metastatic site, the liver and has become by extension a therapeutic standard in France for CRC MPs. However, the impact of delay in the initiation of surgery and adjuvant or neoadjuvant CT is unknown for CRC MPs.

Several deleterious oncologic effects are related to a long period without treatment between

Neoadjuvant chemotherapy and surgery:
Surgery and adjuvant chemotherapy.

Several meta-analyses have demonstrated, for at least 13 different cancers, a continuous association between delays in treatment (CT, radiotherapy, or surgery) and cancer mortality. For CRC, Hanna's meta-analysis showed that for every 4-week delay in adjuvant surgery or CT, the risk of cancer death increased by 6 and 13%, respectively.

These long delays between CT and excisional surgery also decrease survival in patients with liver metastases from colorectal origins and MPs from ovarian origins but this has never been evaluated in patients with MPs from colorectal origins.

Demonstrating an oncologic impact of therapeutic delays would have several strategic practical impacts such as:

Promoting pre- and post-operative rehabilitation programs to facilitate recovery and reduce time to retreatment.
To use more easily techniques (protective stoma, multi-stage surgery) limiting the risk of complications and therefore the delays in treatment.
Propose clinical research protocols aimed at reducing these delays with knowledge of plausible statistical hypotheses.

A therapeutic strategy of shortening the time between each treatment therefore deserves to be evaluated in metastatic forms of colorectal cancer.

The investigators would like to evaluate the hypothesis that shortened time between treatments could have a prognostic impact on recurrence-free survival.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Institut de Cancerologie de L'Ouest
CHU LYON


title: Comparison of Prevention Bacterial Inhalation of Patients on Mechanical Ventilation by Using Endotracheal Tube Balloon Polyvinyl Chloride or Polyurethane

acronym: Top-cuff

summary: A number of techniques have been recommended for the prevention of ventilator acquired pneumonia (VAP). These techniques - such as patient positioning, continuous sub-glottic suction of the secretions, selective decontamination of the digestive tract etc… - aim at prevent the inhalation of oro-pharyngeal contaminated secretions around the cuff of the tracheal tube used for connecting the patient to the machine. Their efficacy has been regularly challenged and they are still unable to suppress totally the occurrence of VAP. The cuff of the tracheal tube used for long-term MV in the ICU is most often a low pressure high volume polyvinyl chloride (PVC) cuff in order to adhere to a large surface of the tracheal wall without inducing ischemic lesions. Recent advances allowed industrial companies to provide us with 1) polyurethane cuffs and 2) cuffs with a conic shape, both potentially offering a better tightness against inhalation at least in VITRO and in animal models. The effect on the reduction of VAP incidence has been suggested by several pilot series. The aim of the present project is to assess the efficacy of four types of cuffs (PVC with a conic or a cylinder shape and polyurethane with a conic or a cylinder shape) to prevent tracheal colonisation. We shall measure both oro-pharyngeal and tracheal colonisation during the hours and days following intubation. This will be done in 600 ICU patients of four university affiliated centres from France and Tunisia divided in 64 cluster randomized groups. The results of this research will confirm (or not) the rationale to perform a larger study designed specifically to address the impact on VAP.

ReferenceCitation: Misset B, Timsit JF, Dumay MF, Garrouste M, Chalfine A, Flouriot I, Goldstein F, Carlet J. A continuous quality-improvement program reduces nosocomial infection rates in the ICU. Intensive Care Med. 2004 Mar;30(3):395-400. Epub 2003 Dec 12.

ReferenceCitation: Koenig SM, Truwit JD. Ventilator-associated pneumonia: diagnosis, treatment, and prevention. Clin Microbiol Rev. 2006 Oct;19(4):637-57.

ReferenceCitation: Garrouste-Orgeas M, Chevret S, Arlet G, Marie O, Rouveau M, Popoff N, Schlemmer B. Oropharyngeal or gastric colonization and nosocomial pneumonia in adult intensive care unit patients. A prospective study based on genomic DNA analysis. Am J Respir Crit Care Med. 1997 Nov;156(5):1647-55.

ReferenceCitation: Dullenkopf A, Schmitz A, Frei M, Gerber AC, Weiss M. Air leakage around endotracheal tube cuffs. Eur J Anaesthesiol. 2004 Jun;21(6):448-53.

ReferenceCitation: Lucangelo U, Zin WA, Antonaglia V, Petrucci L, Viviani M, Buscema G, Borelli M, Berlot G. Effect of positive expiratory pressure and type of tracheal cuff on the incidence of aspiration in mechanically ventilated patients in an intensive care unit. Crit Care Med. 2008 Feb;36(2):409-13.

ReferenceCitation: Philippart F, Gaudry S, Quinquis L, Lau N, Ouanes I, Touati S, Nguyen JC, Branger C, Faibis F, Mastouri M, Forceville X, Abroug F, Ricard JD, Grabar S, Misset B; TOP-Cuff Study Group. Randomized intubation with polyurethane or conical cuffs to prevent pneumonia in ventilated patients. Am J Respir Crit Care Med. 2015 Mar 15;191(6):637-45. doi: 10.1164/rccm.201408-1398OC.

family: Philippart

full_name: François Philippart

given: François

family: Gaudry

full_name: Stéphane Gaudry

given: Stéphane

family: Quinquis

full_name: Laurent Quinquis

given: Laurent

family: Lau

full_name: Nicolas Lau

given: Nicolas

family: Ouanes

full_name: Islem Ouanes

given: Islem

family: Touati

full_name: Samia Touati

given: Samia

family: Nguyen

full_name: Jean Claude Nguyen

given: Jean Claude

family: Branger

full_name: Catherine Branger

given: Catherine

family: Faibis

full_name: Frédéric Faibis

given: Frédéric

family: Mastouri

full_name: Maha Mastouri

given: Maha

family: Forceville

full_name: Xavier Forceville

given: Xavier

family: Abroug

full_name: Fekri Abroug

given: Fekri

family: Ricard

full_name: Jean Damien Ricard

given: Jean Damien

family: Grabar

full_name: Sophie Grabar

given: Sophie

family: Misset

full_name: Benoît Misset

given: Benoît

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

title: Randomized Intubation with Polyurethane or Conical Cuffs to Prevent Pneumonia in Ventilated Patients

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Assessment of Nephrotoxicity Associated to Parenchymal Clamping During Partial Nephrectomy Using a Microdialysis Technique: NECPAR Study

acronym: NECPAR

summary:
Surgery plays a central role in kidney cancer management being the only therapy that offers the possibility of healing the patients. Currently, the partial nephrectomy is a standard technique because it meets the principle of nephron sparing surgery. A partial nephrectomy requires a control of the renal blood flow using a clamp, which can be parenchymal or vascular (pedicular). In France, most of the centers use pedicular clamping. It is well established that this technique results in warm ischemia of the entire healthy parenchyma and can lead to permanent kidney damages. Currently, no study evaluated the impact of parenchymal clamping on the healthy parenchyma.

The aim of the investigators study is to evaluate the nephrotoxicity of the healthy parenchyma due to parenchymal clamping during partial nephrectomy. This assessment will be done through a microdialysis technique. The microdialysis probe is directly implanted in the healthy unclamped parenchyma and will allow us to measure in real time, during the surgery, the biological changes related to anaerobic metabolism of renal interstitial space. All those measures will be completed by urinary and plasmatic assessments. Oxidative stress will be assessed using four markers of tubular viability : Interleukin 18 (IL18), Kidney Injury Molecule-1 (KIM-1), Neutrophil Gelatinase-Associated Lipocalin (NGAL) and cystatin C and four parameters of anaerobic metabolism : lactate, pyruvate, glycerol and glucose.

This is a prospective pilot study limited to 10 patients included over 12 months. Depending on the results, it will be further developed by a second study comparing parenchymal with pedicle clamping.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Effet du Mepolizumab Sur la décroissance de la corticothérapie systémique Chez Des Patients Avec un Asthme éosinophilique sévère Etude Observationnelle, Suivi de Cohorte Via Une ATU Nominative

acronym: Mepolizumab

summary:
The primary objective of the study is to measure the effect of mepolizumab on declines in oral corticosteroid therapy (prednisolone or prednisone) in patients with severe eosinophilic asthma.

Asthma is a chronic inflammatory disease of the airways that affects 5 to 10% of adults and children. Despite current treatments that are often effective, 10% of patients are not controlled by inhaled therapies. These severe asthma require regular use of systemic corticosteroids in 30 to 40% of cases. In this context, the use of glucocorticoids is associated with many more or less serious adverse effects, but still affecting the patient's quality of life. Several treatments have already been proven to save systemic steroids (theophylline, anti-leukotrienes, golimumab ...). On the other hand, none is currently recommended because of a risk / benefit ratio that is too high.

Mepolizumab is a human monoclonal antibody that binds to and inactivates interleukin 5. It has recently been shown to be effective in reducing the daily dose of oral corticosteroids and in reducing exacerbations in these patients with severe eosinophilic asthma. It also reduces the number of eosinophils in the blood and sputum and improves the quality of life.

Patients will receive a subcutaneous injection of 100mg mepolizumab every 4 weeks for one year, for a total of 12 injections.

In France, this treatment was subject to a Temporary Authorization for Nominative Use in severe eosinophilic asthma and is reserved for hospital use.

The injections will be done in HDJ Pneumology CHU Grenoble Alpes and patients will be followed monthly during injections and one month after the end of injections.

ReferenceCitation: Bel EH, Wenzel SE, Thompson PJ, Prazma CM, Keene ON, Yancey SW, Ortega HG, Pavord ID; SIRIUS Investigators. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014 Sep 25;371(13):1189-97. doi: 10.1056/NEJMoa1403291. Epub 2014 Sep 8.

family: Bel

full_name: Elisabeth H. Bel

given: Elisabeth H.

family: Wenzel

full_name: Sally E. Wenzel

given: Sally E.

family: Thompson

full_name: Philip J. Thompson

given: Philip J.

family: Prazma

full_name: Charlene M. Prazma

given: Charlene M.

family: Keene

full_name: Oliver N. Keene

given: Oliver N.

family: Yancey

full_name: Steven W. Yancey

given: Steven W.

family: Ortega

full_name: Hector G. Ortega

given: Hector G.

family: Pavord

full_name: Ian D. Pavord

given: Ian D.

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Oral Glucocorticoid-Sparing Effect of Mepolizumab in Eosinophilic Asthma

ReferenceCitation: Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, Chetta A, Humbert M, Katz LE, Keene ON, Yancey SW, Chanez P; MENSA Investigators. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014 Sep 25;371(13):1198-207. doi: 10.1056/NEJMoa1403290. Epub 2014 Sep 8. Erratum in: N Engl J Med. 2015 Apr 30;372(18):1777.

family: Liu

full_name: Mark C. Liu

given: Mark C.

family: Brusselle

full_name: Guy G. Brusselle

given: Guy G.

family: FitzGerald

full_name: J. Mark FitzGerald

given: J. Mark

family: Chetta

full_name: Alfredo Chetta

given: Alfredo

family: Humbert

full_name: Marc Humbert

given: Marc

family: Katz

full_name: Lynn E. Katz

given: Lynn E.

family: Chanez

full_name: Pascal Chanez

given: Pascal

oa_host_type: repository

repository_institution: University of Liège - Open Repository and Bibliography

title: Mepolizumab Treatment in Patients with Severe Eosinophilic Asthma


title: Study of the Academic and Professional Course of Narcoleptic Patients (NARCOSCOL-NARCOVITAE)

summary:
Narcolepsy is a chronic, disabling, and rare sleep disorder (prevalence 1/2500) characterized by excessive daytime sleepiness and, in some patients, falls in muscle tone related to emotions (cataplexies). It often begins in childhood or in young adults. Symptoms of narcolepsy are responsible for an important handicap in everyday life, and are often misunderstood by the family and professional environment. In addition, many comorbidities are associated with narcolepsy, such as depression, anxiety, or obesity.

Few studies have investigated the impact of narcolepsy on patients' academic background, socio-professional integration, and quality of life.

Narcoleptic patients may experience more difficulties in their academic and professional path than non-narcoleptic people. These difficulties would be multifactorial (related to the disease itself, comorbidities, external factors ...).

As a better understanding of these determinants could help to inform patients and guide them in their choices, this study propose to establish a comprehensive inventory of educational and professional trajectories of narcoleptic patients in France in order assess the specificity of the difficulties encountered by the people concerned in their life course and to appreciate the attitude of the academic and professional circle with respect to the disease.

This category 3 study (according to the French law "Loi Jardé") is based on the case-control model and will be conducted in all National Reference and Competence Centers for Narcolepsy and Hypersomnia. It will include a population of adult and paediatric patients. It will answer questions about work and schooling in these patients.

time_perspective: Cross-Sectional

location_facility: Centre de Médecine du Sommeil et des Maladies respiratoires - Centre Hospitalier de la Croix Rousse - Hospices Civils de Lyon


title: The State of Play in Picardy of the Knowledge of the Elderly at Risk of Falling at Home in Terms of Prevention and Evaluation.

acronym: Epic-SaPE

summary:
In 2010, the French population over 75 years of age was 9%; It will be 13% in 2030 and 19% in 2050 according to estimates. The incidence of falls is high in the elderly population, with at least one fall per year for one-third of the over-65s and for half of the over-80s. These data are consistent with the international medical literature, particularly in Japan, the United States and France, with a high rate of recurrence from the first fall. Falling is a complex phenomenon that is of great importance in terms of morbidity and mortality since it can be followed by serious complications: failure to recover, recurrences, trauma (fractures, hematomas, wounds), complications of decubitus and ulcers, Immobilization, loss of autonomy, hospitalization, institutionalization, psychological complications (post-fall syndrome, depressive syndrome), death.

Fall risk factors are well known and described and relayed by learned societies of geriatrics and medical literature. In addition, HAS reported on this issue in 2009.

The French Society of Geriatrics and Gerontology (SFGG) defines fragility as a clinical syndrome that reflects a decrease in reserve physiological capacities that alters the coping mechanisms of stress. Its clinical expression is modulated by comorbidities and psychological, social, economic and behavioral factors. Frailty syndrome is a risk marker for mortality and pejorative events, including disability, falls, hospitalization and institutionalization. The fall and its complications are closely related to the fragility syndrome. The very fragile patient must take an active part in his own care. He is the first advocate of fall prevention.

On the other hand medical desertification and the low number of geriatricians makes this implication problematic even more so if the person is isolated or has cognitive impairment. Nevertheless, it is important to make the patient actor of his own prevention. This is the first study to describe the knowledge of older adults about their own risk of falling.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Impact of M184V on the Virological Efficacy to Lamivudine/Dolutegravir

acronym: LAMRES

summary:
In view of the prolongation of patients living with HIV's life expectancy, the question of optimization of ART, which is still a life-long treatment, becomes central. While most patients achieve virological success, their treatments often need to be optimized in order to limit adverse events, drugs interactions and to improve adherence. The switch to dual regimen strategies represent one of the approaches for treatment optimization. Indeed, dual therapy regimens have shown non-inferior efficacy vs triple therapy as simplification therapy and more recently also as first line therapy. From the real-life data it emerges that today in simplification strategies, the dual regimen therapies are prescribed even in patients with a history of virological failure. Circulating HIV-1 resistant variants can be archived in viral reservoirs, where they can persist for years and can reemerge in case of therapeutic selective pressure. In particular, previous selection of M184V may have an impact on virological response to 3TC/DTG. There are few data on a direct comparison of 3TC/DTG efficacy in patients harboring or not harboring the M184V. So, there is a need to assess the efficacy of 3TC/DTG in patients with past M184V mutation in a large set of patients followed in clinical setting.

Thus, the investigators propose a retrospective study of patients with HIV-RNA ≤50 copies/mL who were switched to 3TC/DTG in order to compare the virological efficacy of 3TC/DTG in patients with and without a history of M184V detection in a previous resistance genotype. This study aimed to analyze 800 patients switched to DTG/3TC in clinical real setting in large European (France, Italy, Spain) database.

lead_sponsor: Association de Recherche en Virologie et Dermatologie