title: Osteopathy and Prevention of Gastrointestinal Side Effects of the Adjuvant Treatment FEC in Women Treated in Day Hospital for Breast Cancer

acronym: PREDIGOSTEO

summary:
Adjuvant chemotherapy with the protocol 3 cure of 5-FU + Epirubicine + Cyclophosphamide (FEC100) and 3 cure of Taxotere is a standard treatment in the management of patients with breast cancer and in adjuvant situation.

The efficacy of 3 FEC100 and 3 Taxotere protocol in adjuvant situation for women treated for breast cancer is associated with several invalidating side effects for the quality of life of patients. 92% of women treated will present gastrointestinal toxicities of any grade. 11% will present nausea and vomiting of grade 3-4. Current treatments to prevent these gastrointestinal toxicities include Emend from Day 1 to Day 3 in association with setrons at Day 1 and corticosteroids from Day 1 to Day 3. Despite the marked improvement in gastrointestinal toxicities with preventive treatments, 83% of patients would use alternatives medicine: homeopathy, herbal medicine, acupuncture, hypnotherapy and / or osteopathy.

Osteopathy is a method of care and unconventional therapeutic approach. In France, the professional title of osteopath is recognized. It aims to prevent and treat functional disorders, especially those related to adverse effects of treatment. In oncology, this discipline may have additional support for the patient by limiting the mechanical and physical constraints of sensitive areas to the toxicity of the treatment. In the case of gastrointestinal toxicities of myofascial and musculoskeletal techniques are used in abdominal areas to relieve symptoms. The investigators hypothesis is that osteopathy could have an interest in the management of gastrointestinal toxicities related to chemotherapy in women with breast cancer and in adjuvant treatment situation.

ReferenceCitation: Lagrange A, Decoux D, Briot N, Hennequin A, Coudert B, Desmoulins I, Bertaut A. Visceral osteopathic manipulative treatment reduces patient reported digestive toxicities induced by adjuvant chemotherapy in breast cancer: A randomized controlled clinical study. Eur J Obstet Gynecol Reprod Biol. 2019 Oct;241:49-55. doi: 10.1016/j.ejogrb.2019.08.003. Epub 2019 Aug 12.

lead_sponsor: Centre Georges Francois Leclerc


title: Usefulness of Sterile Adhesive Dressing at the Exit-site of Peritoneal Dialysis Catheter: a Pilot Study

acronym: PANCADIPE

summary:
Infection of peritoneal dialysis fluid is a major complication in patients treated with peritoneal dialysis (PD). The aim of catheter emergence care is to reduce bacterial contamination of the peritoneum. The recommendations of the International Society of Peritoneal Dialysis do not provide information on the frequency of care delivery or the usefulness of a sterile adhesive dressing. Thus each treatment center applies a protocol of its own. Dressing is common practice although its safety and interest are not demonstrated.

The usefulness of dressing is still to be demonstrated. On the other hand, the efficacy of the application in prevention of a cream of mupirocin at emergence on the reduction of the risk of infection with staphylococcus aureus (SA), the most frequent germ found in peritonitis, has been demonstrated. A Spanish study showed that during a peritoneal infection at SA the site most frequently colonized by a similar strain of SA was the emergence of the catheter.

It can be considered that an infection of the dialysis liquid in PD is not only related to the quality of emergency care but also to manipulations during exchanges.

Given the number of patients involved in PD in France, it is difficult to obtain sufficient power to formally demonstrate the non-inferiority of the absence of dressing.

Therefore, the investigators propose a descriptive, exploratory study of events that may occur in PD when a dressing is not applied. This is a step prior to performing a multicenter randomized comparative study that will aim to show the non-inferiority of the absence of dressing compared to the application of a dressing on the incidence of fluid infection. peritoneal dialysis.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Supportive Care

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: University Hospital, Caen

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Assessment of Performance and Safety of an Asymmetric Balloon in the Treatment of Intranasal Bleeding Managed in an Emergency Setting

acronym: BATSI

summary:
Between 10 and 12% of the general population suffers from epistaxis, out of which 10% would need to be medically managed. Most of patients treated for epistaxis are managed through emergency departments. The involvement of the ENT (ear, nose and throat) surgeon might be required in more complex situations in order to control bleeding.

Usually, nasal packing packing is used as a first line option after failure of digital compression. Epistaxis balloons are often used after failure of nasal packing Balloons are effective in approximately 60% of the patients with a rapid control of bleeding by compression followed by an absence of rebreeding after balloon removal.

The main challenges for patients treated with this device are i) pain upon balloon introduction and inflation ii) discomfort upon introduction in the nasal cavity as well as during balloon maintenance during 24 to 72 hours of tamponade iii) blood retention between distal and proximal balloons that favors infection iv) limited breathing capabilities through the nostrils which increases general discomfort v) negative aesthetic impact for the patient vi) septal and alar necrosis risk in case of prolonged compression.

Moreover, epistaxis leading to an hospitalization between 24 to 48h are not rare (>11 000 in France in 2017 according to ATIH). Those hospitalizations are often decided in order to ensure an optimal patient monitoring following packing or epistaxis balloon placement.

In order to address those adverse events while keeping the same efficacy and avoiding hospitalizations or reducing their duration, the use of an asymmetric, more physiological, easy to use and mainly intranasal (discreet proximal extremity) is studied.

status: Completed

study_completion_date_type: Actual

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Dianosic

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


title: The Impact of Cesarean Scar Defects on the Success of Assisted Human Reproduction: The Prospective NICHE-ART Study

acronym: NICHE-ART

summary:
The prevalence of Caesarean sections continues to increase around the world. In France, the proportion of Caesarean sections has doubled from 11% in 1981 to 20,2% in 2016, bringing with it an increase in the risk of obstetrical complications.

Uterine defects, or Isthomcele, first defined by Morris in 1995 as a scarring abnormality with a dehiscence of the hysterotomy following a caesarean section. This purely iatrogenic pathology can cause inter-menstrual bleeding or pelvic pain.

Several definitions of isthmosceles exist in scientific literature with variations according to the nature of the reference examination chosen and the measurements made. However, for the majority of authors, isthmoceles are characterized by a residual myometrial thickness of less than 3 millimetres in the sagittal plane. The prevalence of isthmoceles amoung patients with a unicicatricial uterus is about 61%.

Currently, the main diagnostic technique for isthmoceles are 2D or 3D ultrasound and hysterosonography.

Small, non-controlled studies have found that surgical treatment of the isthmocele is effective in reducing metrorrhagia. In these studies, the authors noted that patients with metrorrhagia were also more frequently affected by secondary infertility.

A small number of non-comparative studies with a low level of evidence have looked into the efficacy of surgical treatment of isthmoceles on related symptoms: metrorraghia, pelvic pain and/or secondary infertility. Their results show an idiopathic secondary infertility rate in the presence of isthmoceles prior to surgical treatment of approximately 66%. Significantly higher pregnancy rates after treatment suggest that the surgical management of isthmoceles is worthwhile. However, these data suffer from not negligible selection bias.

The initial findings concerning fertility after surgical repair seem promising and some teams propose systematic surgical management of the isthmocele before a technique of assisted reproduction (ART) although without any evidence in literature.

Isthmocele surgery can result in uterine perforations, adhesions and intrauterine synechia known to be detrimental to future fertility.

The efficacy of surgical management of surgey must therefore be demonstrated prior to any attempts at treatment. This will require large prospective studies based on a consensual definition of isthmocele. The diagnosis using Hysterosonography is currently considered as the "gold standard" examination.

The main hypothesis of our study is that a significant isthmocele, defined by a residual myometrial thickness of less than 3mm, measured in the sagittal plane by hysterosonography, could alter the results of ART.

study_start_date_type: Anticipated

status: Not yet recruiting

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Di Spiezio Sardo A, Di Carlo C, Minozzi S, Spinelli M, Pistotti V, Alviggi C, De Placido G, Nappi C, Bifulco G. Efficacy of hysteroscopy in improving reproductive outcomes of infertile couples: a systematic review and meta-analysis. Hum Reprod Update. 2016 Jun;22(4):479-96. doi: 10.1093/humupd/dmw008. Epub 2016 Mar 23. Review.

ReferenceCitation: Bij de Vaate AJ, van der Voet LF, Naji O, Witmer M, Veersema S, Brölmann HA, Bourne T, Huirne JA. Prevalence, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014 Apr;43(4):372-82. doi: 10.1002/uog.13199. Review.

ReferenceCitation: Donnez O, Jadoul P, Squifflet J, Donnez J. Laparoscopic repair of wide and deep uterine scar dehiscence after cesarean section. Fertil Steril. 2008 Apr;89(4):974-80. Epub 2007 Jul 10.

ReferenceCitation: Osser OV, Jokubkiene L, Valentin L. High prevalence of defects in Cesarean section scars at transvaginal ultrasound examination. Ultrasound Obstet Gynecol. 2009 Jul;34(1):90-7. doi: 10.1002/uog.6395.

ReferenceCitation: Jeremy B, Bonneau C, Guillo E, Paniel BJ, Le Tohic A, Haddad B, Madelenat P. [Uterine ishtmique transmural hernia: results of its repair on symptoms and fertility]. Gynecol Obstet Fertil. 2013 Oct;41(10):588-96. doi: 10.1016/j.gyobfe.2013.08.005. Epub 2013 Oct 4. French.

lead_sponsor: University Hospital, Angers


acronym: TRUE

summary:
This study will be conducted as a retrospective study of exposed and unexposed cohort of the French population included all beneficiaries aged 65 and older. Exposed patients will be matched to non exposed controls according age, gender and area of residence (ratio 1/4). Two exposed arms and two non exposed control arms will be planned. Triptan arm will be user of triptan defined as at least one recorded dispensing of any drug during the follow up, with no recorded of any of these drugs during the previous 6 months ("new or incident users"). Ergot arm will be user of ergot derivative defined as at least one recorded dispensing of any drug during the follow up, with no recorded of any of these drugs during the previous 6 months ("new or incident users"). This study involved data from the French National Health Insurance Information System (Système National d"Information Inter-Régimes de l"Assurance Maladie ; SNIIRAM) linked with the French hospital discharge database (Programme de Médicalisation des Systèmes d"Informations, PMSI).

The SNIIRAM is a vast national medico-administrative database representing the most part of the French population, allowing to identify and to describe precisely all medication dispensations (name of drug, date of dispensing and quantity) including triptans and other reimbursed medications.
The PMSI provides medical information about all patients admitted to hospital in France, including discharge diagnoses encoded according ICD-10, medical procedures and French diagnosis-related groups The research proposed is expected to provide an update and nationally-consolidated estimation of the cardiovascular risk is associated to triptans use in elderly population.

status: Unknown status

time_perspective: Retrospective

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille

intervention_type: Drug

status_simplified: Unknown


type: Other Identifier

title: cKIT, BRAF/NRAS Mutations in Advanced Melanoma : Clinical Outcome in Response to Tyrosine-kinase Inhibitors - KitMel Project

acronym: KitMel

summary:
Background: Metastatic melanoma has a devastating prognosis and is one of the top causes of cancer death in young patients. Until now, available therapies were few and unreliable, but recent understanding of melanomas' molecular pathways has improve their classification and new clinical strategies have been proposed.

Initial studies showed that B-Raf/N-Ras mutations (respectively V600E and Q61) are the most frequent alteration being present in 70 to 80% of melanomas, characterizing non Chronic Sun-induced Damage skins (CSD). These include Superficial Spreading Melanomas (SSM) and Nodular Melanomas (NM). Other studies showed that c-Kit mutations are presently the predominant activating mutation (20 - 40 %) in Acro-Lentiginous Melanomas (ALM), Mucous Melanomas (MM) and in melanomas arising on CSD skin. c-Kit mutation pattern is more complex with four exons being affected leading to different mutations, which incidence and biological impact are less documented.

BRAF/NRAS genetics alterations drive constantly cell growth, being thus attractive targets. Spectacular results have indeed been obtained with the BRAF inhibitor that targets the V600E BRAF-mutated form. Data from GIST disease revealed that the different c-Kit mutations modulate differently c-Kit function and the response to targeted therapies.

Because c-Kit targeted therapy is a critical clinical issue, the investigators aimed to identify the most frequent mutations present in our population to propose appropriate screening test and adapt the therapy.

Methods: 250 melanoma samples corresponding to an homogeneous white-Caucasian population (Brittany, France) will be screened. c-Kit exons 11, 13, 17 and 18 will be sequenced (direct sequencing and pyrosequencing when possible). c-Kit copy number will be quantified by q-PCR and level of c-Kit determined by immunohistochemistry (IHC, CD117). Samples will also be analyzed for B-Raf mutations in codon 464, 466, 469 and 600, and for N-Ras mutations in codon 12, 13 and 61 (Pyrosequencing).

Expected Results:

Taken together, the investigators anticipate that the present genetic analysis of the tumours from patients with advanced melanoma will first document the type and frequency of cKit mutations, will confirm or not that BRAF, NRAS and cKit mutations are mutually exclusive and document their repartition in the melanomas sub-types. Finally this study will clue researchers in to how well patients will respond to a therapy that targets the growth-promoting proteins BRAF/NRAS and cKIT.

primary_purpose: Diagnostic

lead_sponsor: Rennes University Hospital

location_facility:
Centre Eugène Marquis
Rennes University Hospital


title: Satisfaction Survey After Distal Surgery Performed Under Local Infiltration (Walant) or Under Axillary Block

acronym: WALAX

summary:
In the 1970s-1980s, Dr. Donald Lalonde (surgeon, Canada) developed an anesthetic technique for hand surgery called WALANT (Wide Awake Local Anesthesia No Tourniquet). This technique is based on the joint administration of a local anesthetic (lidocaine) and epinephrine (adrenaline), which limits bleeding and makes it possible to dispense with a tourniquet. In addition, and contrary to truncal anesthesia, this combination of drugs infiltrated opposite the surgical site preserves the mobility of the limb. However, this technique is not without risk and some adverses events have been reported: intoxication by local anesthetics due to overdose and digital necrosis with the use of procaine or cocaine.

Currently in France, truncal anesthesia with a pneumatic tourniquet on the arm is often preferred for hand surgery (axillary block or BAx). In this case, the pneumatic tourniquet is used to minimize intraoperative blood loss and improve the visibility of the operating field. However, it can be a source of discomfort, pain, or transient neurological deficit.

To date, few studies comparing WALANT and BAx are available and none have evaluated the perioperative experience of patients and the incidence of paresthesias in the short and long term.

In order to measure the perioperative satisfaction of patients undergoing hand surgery with BAx or WALANT, we conduct a prospective observational non-randomized study evaluating the EVAN-LR satisfaction score at D0. The secondary objectives of the study are to evaluate postoperative adverse events (digital necrosis, paresthesias, local anesthetic intoxications, infection of the operated limb), consumption of postoperative analgesic treatments in both groups.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Prospective, Monocentric, Randomized, Open-label Study Comparing the Efficacy, in Terms of Quality of Life, and Safety of RAdiofrequency Versus HAL- RAR DOppler in Hemorrhoidal Pathology

acronym: RADO

summary: Haemorrhoids are composed of tissue rich in blood vessels and are present in all individuals inside the anus (internal haemorrhoids) or under the skin of the anus (external haemorrhoids). Haemorrhoidal disease (HD) occurs when haemorrhoids become troublesome and cause symptoms such as pain, bleeding, prolapse or oozing. In case of failure of medical treatment, instrumental procedures or extensive disease, surgical treatment can be considered. There are two classic surgical techniques. The first is the pedicle haemorrhoidectomy of the Milligan and Morgan type. The second classic surgical technique is the Longo stapled anopexy. Recently, less invasive surgical techniques such as arterial ligation (HAL, with or without Doppler) followed by recto-anal repair (RAR for "Recto Anal Repair") and sometimes associated with mucopexy, which allows the excess mucosa to be ligated and the muco-haemorrhoidal tissue to be fixed to the rectal wall, have developed. The use of radiofrequency current (Rafaelo technique) in the treatment of haemorrhoidal disease is an innovative technique of haemorrhoidal thermocoagulation. It is a mini-invasive technique, which can be performed under sedation or short general anaesthesia (GA), with little pain, allowing a rapid return to normal life and a short time off work. Although this technique is already used in other European countries: Poland, Germany, Belgium, Great Britain (UK), there is now a Polish, German, Spanish and English study in the process of publication. There have been no studies in France to evaluate this new technique and assess its good tolerance, the duration of work stoppage, the improvement in quality of life and the evaluation of its effectiveness.

design_allocation: Randomized

ReferenceCitation: Aigner F, Bodner G, Gruber H, Conrad F, Fritsch H, Margreiter R, Bonatti H. The vascular nature of hemorrhoids. J Gastrointest Surg. 2006 Jul-Aug;10(7):1044-50.

ReferenceCitation: Brown SR, Tiernan JP, Watson AJM, Biggs K, Shephard N, Wailoo AJ, Bradburn M, Alshreef A, Hind D; HubBLe Study team. Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial. Lancet. 2016 Jul 23;388(10042):356-364. doi: 10.1016/S0140-6736(16)30584-0. Epub 2016 May 25. Erratum in: Lancet. 2016 Jul 23;388(10042):342.

ReferenceCitation: Loder PB, Kamm MA, Nicholls RJ, Phillips RK. Haemorrhoids: pathology, pathophysiology and aetiology. Br J Surg. 1994 Jul;81(7):946-54. Review.

ReferenceCitation: Morgado PJ, Suárez JA, Gómez LG, Morgado PJ Jr. Histoclinical basis for a new classification of hemorrhoidal disease. Dis Colon Rectum. 1988 Jun;31(6):474-80.

ReferenceCitation: Pigot F, Siproudhis L, Allaert FA. Risk factors associated with hemorrhoidal symptoms in specialized consultation. Gastroenterol Clin Biol. 2005 Dec;29(12):1270-4.

ReferenceCitation: Riss S, Weiser FA, Schwameis K, Riss T, Mittlböck M, Steiner G, Stift A. The prevalence of hemorrhoids in adults. Int J Colorectal Dis. 2012 Feb;27(2):215-20. doi: 10.1007/s00384-011-1316-3. Epub 2011 Sep 20.

ReferenceCitation: Simillis C, Thoukididou SN, Slesser AA, Rasheed S, Tan E, Tekkis PP. Systematic review and network meta-analysis comparing clinical outcomes and effectiveness of surgical treatments for haemorrhoids. Br J Surg. 2015 Dec;102(13):1603-18. doi: 10.1002/bjs.9913. Epub 2015 Sep 30. Review.

ReferenceCitation: CRETON D. et le groupe closure®.Oblitération tronculaire saphène par le procédé radiofréquence VNUS Closure ®. résultats à 5 ans de l'étude multicentrique prospective,Phlébologie 2006,59 :67-72

ReferenceCitation: Becq A, Camus M, Rahmi G, de Parades V, Marteau P, Dray X. Emerging indications of endoscopic radiofrequency ablation. United European Gastroenterol J. 2015 Aug;3(4):313-24. doi: 10.1177/2050640615571159. Review.

ReferenceCitation: VIVALDI.C,. TOLKSDORFS. SCHAFER H., Radiofrequency ablation of hemorroïds. First results of a new technique The Rafaelo Procedure.Endarmpraxis;Colorectal disease 2017, 19 (suppl 2) p.138

ReferenceCitation: BORD C., PILLANT H., FAVREAU-WELTZER C., SENEJOUX A., SOUDAN D., ARREDONDO BISONO T., ZKIK A., BERDEAU G., ABRAMOWITZ L. Development of A Validated Questionnaire Evaluating The Burden of The Haemorrhoidal Disease and Anal Fissure (Hemo-Fiss). Value in Health, VOLUME 18, ISSUE 7, PA630, NOVEMBER 01, 2015

lead_sponsor: Elsan


title: Randomized, Prospective, Multicenter Blinding Singles With Arm A and Arm B Innovative Strategy Strategy Conventional

acronym: RESECT

summary:
Glioblastoma is the most frequent primary malignant brain tumor in adults (3,000 new cases per year) and is characterized by a poor prognosis (median survival 12 months). Treatment is based mainly on surgical excision as complete as possible followed by an additional radiochemotherapy. The prognosis depends mainly on the quality of resection when it is macroscopically complete. Different techniques to support the surgical resection have been developed over the past 20 years. The reference technique is currently the intraoperative neuronavigation for guiding excision by matching the intraoperative tumor boundaries with those of the preoperative MRI. Its main drawback is the loss of precision during the resection related to changes in anatomical limits of the tumor.

The per-operative fluorescence-guided surgery (FGS) is an innovative alternative technique to support the surgical resection. The 5-aminolevulinic acid (5-ALA), a molecule absorbed by the patient before surgery is captured specifically by the tumor cells and transformed into a fluorochrome revealed intraoperatively by a light source length adapted wave with a set of lenses included in the microscope. Resection is thus guided by this fluorescence whose disappearance translates complete tumor resection.

Its interest is twofold:

Increase the percentage of complete tumor resection.
Improve disease-free survival and overall survival. The objective of the study is to compare the FGS to the intraoperative neuronavigation for the resection of glioblastoma, on a medical and economical level through a randomized, prospective, multicenter trial.

The annual number of patients likely to benefit of this technique in France is estimated at 2200 new cases.

lead_sponsor: Hospices Civils de Lyon


title: Injured - Sport Health Armed Forces (Blessé - Sport Santé Armées): Reconstruction Through Sport in the Armed Forces

acronym: B-SSA

summary:
Since 2014, the armed forces have been offering injured military personnel the opportunity to rebuild their lives through sport. Sport, considered as the "DNA" of the military, thus becomes a vector of socio-professional reintegration for physically and psychologically injured soldiers.

In its 2019-2024 national Sport-Health strategy and in the Ministry of the Armed Forces' "Sport 2025" plan, rebuilding injured military personnel through sport is becoming a major focus of the new sports policy for the armed forces.

In addition to the well identified physiological benefits, sports are recognized as a way to encourage social relationships, fight stress and isolation, and promote solidarity. Sport thus contributes to the physical and mental reconstruction of the injured, promoting the phenomenon of resilience well described in the Anglo-Saxon world.

The implementation of the Reconstruction through Sport Program ("PRS") is based on the coordinated actions of the assistance units for the wounded, the French Armed Forces Health Service and the National Center for Defense Sports (CNSD), which have set up a complete sports program (discovery, leisure, competitions), adapted and evolving, regardless of the physical and/or psychological after-effects and the disability secondary to the injury.

In France, there are an increasing number of PRS-labeled sports events, such as the Military Injury and Sports Meetings, the Ad Victoriam Challenge, and internationally, the Invictus Games and the Military World Games. It should also be noted that this pathway leads some injured people to high-level competition.

No study has yet evaluated the path of reconstruction through sport for French injured military personnel initiated in 2014.

lead_sponsor: Direction Centrale du Service de Santé des Armées


title: Regional Anesthesia in Refractory Trigeminal Neuralgia: 21 Cases Reported to the Limoges University Hospital

acronym: TRINEB ONE

summary: Trigeminal neuralgia is defined according to the third edition of the International Classification of Headache Disorders (ICHD-3) criteria. Chronic pain can have a major impact on the quality of life. First-line treatments are anti-epileptics, and surgical treatments are also possible according to several approaches. Sometimes the pain is resistant to these therapies. In this indication, sensory blocks may have a therapeutic impact but their place is not clear. In France, there are formalized expert recommendations on "loco regional analgesia and chronic pain", from 2013. Several adjuvants to local anesthetics have been studied for acute and chronic pain. CLONIDINE and DEXAMETHASONE are of greatest interest in increasing block duration and reducing opioid consumption. The investigators report the case of 21 patients, treated by a trigeminal block from 2014 to 2018, suffering from a resistant trigeminal neuralgia. After a first consultation, the diagnosis is confirmed, an information is done and an appropriate support is established. The sensory block is performed as an outpatient care. It consists in a peri-neural injection of a mixture of LEVOBUPIVACAINE 5%, CORTIVAZOL 3.75mg / 1.5mL (or BETAMETHASONE 7mg / 1ml) and CLONIDINE (1μg / kg). Standard precautions are respected and patients are monitored in the recovery room after the procedure. The efficacity is evaluated before the exit and a follow-up is done within 15 days. The level of satisfaction expressed by the patients seems to be globally high. The investigators wish to evaluate statistically the impact of the trigeminal blocks, in terms of improvement of the quality of life. This retrospective study, by its procedure, does not change the management of patients.

lead_sponsor: University Hospital, Limoges


type: EudraCT Number

title: Baricitinib in Patients With Relapsing or naïve Dermatomyositis: a Multicenter Randomized Controlled Trial (BIRD)

acronym: BIRD

summary:
Dermatomyositis (DM) is a rare and disabling condition with an important impairment of quality of life and possible life-threatening complications.

Treatment is based on high doses of corticosteroids but this exposes patients to adverse events (cardiovascular mortality, glucocorticoids-induced muscle and skin damages). Corticosteroids taper is associated with disease relapses. Although there is no evidence from the literature, clinical practice guidelines recommends the use of DMARDs such as methotrexate. However, response is not complete and these DMARDS take time to act.

The interferon type I (IFN-I) pathway is involved in the pathophysiology of DM. Janus kinase 1 and 2 transduces IFN-I signals. In addition, JAK2 inhibition enhances muscle repair and force generation.

JAK 1/2 inhibitors permitted to dramatically and rapidly improve relapsing DM patients (n=4, case series).

Our hypothesis is that Janus kinase 1 and 2 (JAK1/2) inhibitors (baricitinib) will permit to obtain dermatomyositis (DM) improvement with a steroid sparing effect as compared to usual care.

Our primary objective is to evaluate the efficacy of baricitinib (JAK1/2 inhibitor) to obtain prednisone-free moderate improvement (ACR/EULAR ≥ 40) of DM as compared to placebo in addition to usual care.

BIRD is a multicenter phase III double blind randomized placebo-controlled trial with two parallel arms (1:1). This is an add-on trial to usual care with rapid corticoid taper.

This is a multicenter trial in different medical departments in hospitals across France in different regions.

Out- and in patients will be recruited in hospital departments involved in management and diagnosis of DM: departments of dermatology, rheumatology and internal medicine.

ipd_sharing: Yes

ipd_sharing_description:
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Preventive Norepinephrine Infusion During Surgery for Upper Femoral Fracture and Post-operative Acute Renal Failure

acronym: NORAKI

summary: The fracture of the upper extremity of the femur (FESF) is one of the most common fractures in traumatology. In France, FESF affects more than 65,000 individuals per year and could involve up to 150,000 people per year by 2050, due to the increase in life expectancy of the population. The main risk factors for the occurrence of ESF are: age, gender, osteoporosis, undernutrition, gait and balance disorders. The main risk factors for death identified by the French Society of Orthopaedic Surgery and Geriatrics after surgery for ESF are: a delay between the trauma and surgery of more than 48 hours, poorly tolerated preoperative anemia or a hemoglobinemia of less than 8 g/dl, absence of antibiotic prophylaxis, postoperative acute renal failure, and discontinuation of antiaggregant treatments in the case of coronary disease. Post-operative Acute Kidney Injury (AKI) is one of the risk factors for mortality after surgery for ESF. AKI is an impairment of normal kidney function, and in general, AKI is a major issue in the management of patients undergoing surgery. In the short term, it increases the length of stay of patients, and the number of admissions to continuing care. AKI increases post-operative mortality by more than 50%. However, because of the complications associated with vascular filling, the use of vasoconstrictor drugs, such as ephedrine, phenylephrine, and especially norepinephrine, is increasingly common. Compared with other catecholamines, norepinephrine has been shown to be more effective in increasing cardiac output. Moreover, unlike bolus administration of ephedrine or phenylephrine, which favor the occurrence of blood pressure peaks and valleys, norepinephrine, administered as a continuous infusion, allows blood pressure to be maintained in a narrower range. The challenge is to implement a strategy to reduce their frequency. Intraoperative arterial hypotension is one of the risk factors on which investigators can intervene thanks to the "preventive" administration of noradrenaline in continuous infusion, started before or immediately after the induction of anesthesia. However, the "preventive" use of norepinephrine may favor the occurrence of AKI in hypovolemic patients (fracture and surgery-related bleeding, prolonged fasting) by reducing renal blood flow. Our primary objective is to compare the risk of AKI occurrence during a "preventive" norepinephrine administration strategy with a target MAP ≥65 mmHg compared with that observed in response to a vasoconstrictor-only administration strategy in response to the occurrence of arterial hypotension episodes. Secondary objectives are to evaluate the potential interactions of this preventive strategy with other risk factors for postoperative AKI.

status: Active, not recruiting

ReferenceCitation: Bhandari M, Swiontkowski M. Management of Acute Hip Fracture. N Engl J Med. 2017 Nov 23;377(21):2053-2062. doi: 10.1056/NEJMcp1611090. Review.

ReferenceCitation: Brauer CA, Coca-Perraillon M, Cutler DM, Rosen AB. Incidence and mortality of hip fractures in the United States. JAMA. 2009 Oct 14;302(14):1573-9. doi: 10.1001/jama.2009.1462.

ReferenceCitation: Dadure C, Marie A, Seguret F, Capdevila X. One year of anaesthesia in France: A comprehensive survey based on the national medical information (PMSI) database. Part 1: In-hospital patients. Anaesth Crit Care Pain Med. 2015 Aug;34(4):191-7. doi: 10.1016/j.accpm.2014.12.003. Epub 2015 Jun 30.

ReferenceCitation: Sykes L, Kalra PA, Green D. Comparison of impact on death and critical care admission of acute kidney injury between common medical and surgical diagnoses. PLoS One. 2019 Apr 11;14(4):e0215105. doi: 10.1371/journal.pone.0215105. eCollection 2019.

ReferenceCitation: Ahuja S, Mascha EJ, Yang D, Maheshwari K, Cohen B, Khanna AK, Ruetzler K, Turan A, Sessler DI. Associations of Intraoperative Radial Arterial Systolic, Diastolic, Mean, and Pulse Pressures with Myocardial and Acute Kidney Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2020 Feb;132(2):291-306. doi: 10.1097/ALN.0000000000003048.

ReferenceCitation: Wood RJ, White SM. Anaesthesia for 1131 patients undergoing proximal femoral fracture repair: a retrospective, observational study of effects on blood pressure, fluid administration and perioperative anaemia. Anaesthesia. 2011 Nov;66(11):1017-22. doi: 10.1111/j.1365-2044.2011.06854.x. Epub 2011 Aug 18.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Assessment of the Effects of Early Proprioceptive Stimulations in Patients With Spinal Cord Injury : a Randomized Controlled Trial

acronym: Tetra-Mouv

summary:
"Spinal cord injury (SCI) is a dramatic event resulting in a long-term handicap. Appropriate care from admission to the intensive care unit (ICU) is a key element not only for the survival of these patients but also to promote their recovery. Moreover, the studies on natural history of SCI have shown that most of the recovery occurs within the first 3 to 6 months post-injury. This period is therefore crucial for these patients. However, the environment of the ICU and the acute condition of the patients limit the rehabilitation possibilities. In such a context, functional proprioceptive stimulations (Vibramoov™ system, Techno Concept, France) could be a tool of interest.

By using tendon vibrations, the Vibramoov™ system allows to reproduce the proprioceptive signatures of cyclic movements such as walking. Some studies have already demonstrated the benefits of proprioceptive vibrations. However, so far, these benefits have only been studied at the chronic stage of neurological diseases.

The investigators hypothesized that early functional proprioceptive stimulations (FPS) may reduce spasticity and promote sensorimotor recovery in tetraplegic and high paraplegic patients.

To test their hypothesis, the investigators conduct a randomized controlled trial on 40 patients with traumatic SCI. These patients will be stratified into two groups according to the completeness of their lesion. Every patient will be included within ten days post-injury and receive either FPS, either sham stimulations to the joints of the lower limbs, 4 times a week during 8 weeks. the primary outcome measures will assess spasticity. the investigators also assess sensorimotor recovery, pain, muscle wasting, cognitive impairment and functional status. "


title: Evaluation of Early Association of Terlipressin and Norepinephrine During Septic Shock; the TerliNor Study

acronym: TERLINOR

summary:
In guidelines norepinephrine is the first line vasopressor recommended in case of septic shock. Use of vasopressin is recommended when norepinephrine fails to maintain a mean arterial pressure above 65mmHg or in salvage. Several studies failed to show a superiority of vasopressin over norepinephrine but none evaluated the effect of an early association on organ failure. Terlipressin is a pro-drug of vasopressin which has the same vasoconstrictor effect. We hypothesize that the early association of terlipressin and norepinephrine during septic shock reduces organ failure.

This bi centric, double-blinded, randomised, controlled versus placebo study includes 40 patients. Randomisation will be stratified between centers (two university affiliated intensive care units of Assistance-Publique-Hôpitaux de Marseille, Marseille, France). All patients with septic shock needing more than 0,5µg/kg/min of norepinephrine to reach PAM objectives are randomised, after hemodynamic evaluation and optimisation, to receive continuous infusions of terlipressin (0,01mg/kg/min) or placebo (physiologic serum). The 2 groups receive steroid therapy (continuous intravenous hydrocortisone perfusion) at this time. Clinicians are blinded of perfusion used. Use of terlipressin remains possible in salvage when patients need more of 1µg/kg/min of norepinephrine on physician's decision. Patients with acute ischemic or septic heart failure are excluded of the study.

Primary objective is sepsis related Sequential Organ Failure Assessment (SOFA) score difference between the groups at day 3. Secondary objectives are mortality at day 28, lactates clearance in the first 48hours, renal function (evaluates with AKIN criteria) and use of renal replacement therapy.

location_facility: Assistance Publique - Hôpitaux de Marseille


title: Contribution of Canine Detection in the Diagnostic Strategy of High-risk Prostate Cancer

summary: The sense of smell allows both humans and dogs to carry out a chemo-sensory analysis of their environment. Volatile organic compounds enter the nasal cavities and bind to receptors in the nasal mucosa. Neuroepithelium cells perform chemoelectric transduction of olfactory information. The latter is supported by one of the fibers of the olfactory nerve which crosses the cribriform plate of the ethmoid to arrive in the olfactory bulb of the brain. Incorporating this information can lead to behavioral responses. The dog has a sense of smell 100,000 times more sensitive than humans, it is able to detect one particle among 1 trillion. The use of detection dogs involves learning the behavioral response to an olfactory stimulus. Prostate cancer represents 25% of male cancers, it is the second deadliest cancer in France with 10,000 deaths per year. Diagnosis of prostate cancer requires a Prostate Specific Antigen (PSA) blood test and a digital rectal examination. In the event of an abnormality in one of these parameters, a prostate MRI is indicated, supplemented by prostate biopsies in the event of an abnormal MRI. However, one situation remains open to discussion: what should be done when faced with a normal MRI despite an abnormal PSA level or digital rectal examination? In this situation and according to current recommendations, the practitioner has the choice between performing prostate biopsies, i.e. an invasive procedure with a high risk of being negative, and simple monitoring, this time with the risk of missing the diagnosis of prostate cancer. Several studies have shown the effectiveness of dogs in detecting very specific volatile organic compounds. Can the investigators train them to detect the catabolites of prostate tumours?


title: Pilot Study of ILIADE: Exploring Health Literacy Within Patients Hospitalized for Acute Cardiovascular Events

acronym: P-ILIADE

summary:
Health literacy (HL) 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 is known as a health determinant. An association has been shown between low health literacy and low health outcomes such as increased number of unscheduled hospitalization 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 many scientific international literature about health literacy and health outcomes, no information is available in France on the prevalence of low health literacy level of patients, notably cardiovascular patients. The investigating team's hypothesis is that knowing the prevalence of low HL levels in cardiovascular patients would help to better tailored a communication intervention dedicated to the needs of these low-HL patients with the final aim of increasing their adhesion to preventive drugs and behavioural recommendations.

The first aim of the present study is to estimate the prevalence of low HL level among patients discharged after acute myocardial infarction or acute decompensation of chronic heart failure. Secondary aims are to assess factors associated with the level of HL and identify barriers and facilitators of low HL patients to understand medical information on their disease. The results of this study will guide the design of the intervention of an interventional study on HL of cardiovascular patients.

ReferenceType: derived

ReferenceCitation: Perrin A, Damiolini E, Schott AM, Zermati J, Bravant E, Delahaye F, Dima AL, Haesebaert J. Considering health literacy in cardiovascular disease management: a qualitative study on healthcare professionals' and patients' perspectives. BMC Health Serv Res. 2022 Sep 5;22(1):1121. doi: 10.1186/s12913-022-08455-8.


title: Medico-economic Evaluation of the ONCORAL Program of Multidisciplinary ONCOlogic Interventions Between Town and Hospital (Doctor-pharmacist-nurse) for Ambulatory Patients Under oRAL Anticancer Drugs Versus Usual Care

acronym: ONCORAL-PRME

summary:
Economic impact of cancer treatments is increasing for years: increase of number of patients (385 000 new occurrences in 2015), increase of life expectancies, chronicization of diseases and increase of therapeutic innovation costs.

Oral anticancer drugs allow the ambulatory turn in oncologic treatments, avoid hospitalizations dues to injectable chemotherapies and improve patient autonomy. In real life situation, these drugs still remain linked to significant drug iatrogenic effects: prevalent adverse events and potentially serious ones, drugs interactions for one other patient, considered as major in 15-20% cases, and non-observance for 30-50% patients.

The resultant care overconsumption and the high cost of new oral targeted therapies appear as a substantial financial charge to the Health related program. Securing oral chemotherapy and their good practice therefore represent a real economic challenge and lead health care professionals to develop town-hospital programs of ambulatory patient's follow-up under oral anticancer drug in response of third Cancer Plan.

Benefice of such interventions are proved on observance, management of adverse events and drug interactions.

However, the effectiveness of these programs has not been evaluated and no studies have been conducted in France.

The Investigators propose here to carry out a medico-economic study of high level of proof of the ONCORAL program. This study will be the first evaluation of the effectiveness of a program for monitoring outpatient oral cancer patients versus usual care.

The results of this study will contribute to the national reflection on the path of care of patients treated by oral chemotherapy, on the assessment of needs and the evolution of the supply of care and its financing.

intervention_type: Behavioral


title: Double-Blind Randomized Controlled Trial Evaluating the Efficacy of the Food Supplement Isitol® Versus Placebo on the Rate of Abnormal Sperm DNA Fragmentation

summary:
In industrialised countries, it is estimated that about 15% of couples who wish to have a child are currently facing infertility problems, of which, in half of the cases, an anomaly in sperm quality or at least a factor of male origin is identified. The evaluation of sperm quality in males is based, for the most part, on the micro and macroscopic examination of various parameters (concentration, motility, physical abnormalities of the spermatozoa, etc.). Nevertheless, an increasing number of scientific studies have shown that the quality of sperm DNA, and in particular its fragmentation rate, is also associated with a lower fertilisation rate. The integrity of sperm DNA may be affected by an imbalance in the Red/Ox balance leading to uncompensated oxidative stress, and could be restored or improved by dietary hygiene measures and the consumption of specific dietary products. The ISITOL clinical study aims to evaluate the efficacy of a dietary supplement specifically formulated to target the various issues associated with male infertility, and in particular to contribute to the improvement of the sperm DNA fragmentation rate. The efficacy of the dietary supplement Isitol® (GYNOV SAS) on sperm DNA fragmentation rate and other secondary parameters is being evaluated through a single-centre, prospective, randomised, double-blind, interventional vs. placebo clinical study being conducted in France at Laboratoire Drouot (21 Rue Drouot - 75009 Paris - France) and led by Dr. Nino-Guy Cassuto. A total of 72 men aged between 20 and 45 years, with sperm DNA fragmentation rate ≥ 30% and with negative semen culture are recruited. The recruited patients were randomized in a 1:1 scheme into 2 groups (Isitol® treated vs placebo treated).

[Results to be reported later]

lead_sponsor: GYNOV

intervention_type: Dietary Supplement


title: Evaluation of the Efficiency of KINETUBE® in the Recurrent Chronic Tubal Ear Otitis Care (Otitis Media With Effusion, Atelectatic Otitis or Retraction) in Children With an Age Range of 7-15 Years.

acronym: KINETUBE

summary:
Otitis media are the consequence of bacterial infection. They are characterized by middle ear inflammations with a collection of fluid behind the eardrum. The effusion stagnates in the middle ear, can increase acute infection and induce tympanic membrane and inner ear damages. Delay in language learning can be observed in affected children as well as hearing problems e.g. constant hearing loss. The two main forms of chronic otitis are otitis media with effusion (OME) and atelectasis with or without retraction pockets.

To date, insertion of tympanic ventilation tubes (tympanostomy) is the most effective treatment for otitis media with effusion that has failed to respond to conservative drug treatments; and for delaying the progression of serious atelectasis. When a first tube did not allow complete recovery, recurrence is then observed and insertion of new tube is needed. The repeated tube insertions increase risks linked to general anesthesia and increase rate of sequelae/complications, such as tympanic membrane perforation.

Kinetube® is a CE-marked medical device, marketed in France and Europe since April 2002. This device improves the neuronal control mechanism of the pharyngotympanic (Eustachian) tube, regulating middle ear pressure. This could be an alternative for patients having recurrence and needing repeated tube insertion, as studies had shown that Kinetube® improved the opening of the Eustachian tube in patients with otitis media with effusion (OME) and atelectasis.

These previous clinical studies have shown the feasibility of the use of Kinetube® in clinical practice. A larger clinical study with a high level of evidence must be performed to show therapeutic efficacy of the Kinetube® in chronic otitis compared to ventilation tube insertion.

location_facility: Assistance Publique Hopitaux de Marseille


title: Pilot Study of Active Desk in Primary School : Effects on the Attention, Cognitive Capacities, Physical Capacities, Concentration and Well-being of Student and on the Classroom Climate

acronym: BICLASS

summary:
Physical activity (PA) is insufficient in children with three quarters of them who do not meet the WHO's recommendations. Physical inactivity is growing during adolescence; in part due to the time spend in sedentary behaviors at school. The recent literature is highlighting the importance of physical activity on academic achievement, physical fitness and academic achievement in children. In addition, deleterious effects of sedentary behaviors have been demonstrated. At school, many strategies have been settled to break the prolonged sitting time. The use of workstations is one of them and allows to reduce sedentary time at school and increases physical activity without interrupting class. Active workstations like bike desks have demonstrated their effectiveness on physical activity but their effects have not been evaluated in primary school in France. In addition, few studies have evaluated the effects of bike desk use on the child's cognitive abilities.

The main objective of this project is to measure the variations linked to the use of bike desks (desk with pedals) for an average of 1h45mn per week (30min 3 to 4 times per week) for 13 weeks during school time in primary school pupils (aged 8 to 11 years) on the cognitive abilities (mental flexibility, working memory and inhibition) of children.

Our hypothesis is that the use of the bike desk for 1h45 per week will induce an increase in the attention and cognitive capacities (mental flexibility, working memory and inhibition) of the children. Other improvements that should be identified are the child's body composition, the classroom climate and the well-being of pupils and teachers. The children's physical capacities could also be increased, beyond what is expected given the normal evolution during the year.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Cohort of Patients Presenting Unexplained Recurrent Miscarriages and Identification of Early Miscarriage Recidivism Factors

acronym: FALCO

summary:
About 1 to 3% of women of childbearing age have repeated early spontaneous miscarriages (RCF) defined by at least 3 fetal losses before 14 weeks of gestation. RCFs may be related to parental chromosomal abnormalities, congenital or acquired uterine abnormalities, hormonal causes (e.g. type 1 and 2 diabetes, ovarian failure), infectious etiology, constitutional or acquired thrombophilia or sickle cell disease.

The presence of antiphospholipid antibodies, antithyroid and anti-transglutaminase antibodies in approximately 10% of cases suggests an autoimmune origin for these fetal losses. The role of other antibodies, in particular unconventional antiphospholipid antibodies, remains to be established. Indeed half of RCF cases would be due to an immunological dysregulation of the mother leading to a decrease in tolerance to the fetus. Several studies have shown immune abnormalities, such as an imbalance of pro and anti-inflammatory cytokines, an increase in cytotoxic cells and a defect in regulatory cells in the blood of patients. The assessment of these immune abnormalities is not currently carried out routinely in France in women with recurrent early miscarriages.

When one of these known causes is excluded, it is unexplained RCF which represents 50% of RCF. In these women with unexplained RCF, slightly more than half could be linked to aneuploidies and primary recurrent spontaneous abortions. The evaluation of the degree of aneuploidy and the genetic origin of fetal losses remains difficult, the examination of the sample of tissue from the miscarriage being rarely available, due to the spontaneous nature of the loss.

The constitution of a prospective cohort of patients with RCF is an essential step in exploring the factors associated with the success of treatment.

location_facility: Internal medicine department, hospital Saint Antoine

intervention_type: Biological


title: Cultured Autologous Oral Mucosa Epithelial Sheet for the Treatment of Bilateral Limbal Stem Cell Deficiency FEMJA for " Feuillet Epithélial de Muqueuse Jugale Autologue "

acronym: FEMJA

summary:
Some severe ocular burns or other rare ocular pathologies can be associated with a total loss of corneal epithelial stem cells (i.e. Limbal Stem Cell Deficiency - LSCD), which leads to cornea invasion by the conjunctiva and a subsequent opacification. When LSCD is total and bilateral, both eyes are affected leading to full blindness and a poor quality of life, with a paradoxical photophobia that may be painful. Fewer than 100 patients bear this rare condition in France.

When patients suffer from total and bilateral LSCD, no treatment has been proven to provide clinical benefits: contralateral limbus is unavailable for autologous limbus graft or autologous limbal stem cells culture; allogeneic limbus graft requires immunosuppressive treatment leading to too important serious adverse effects compared to the expected benefit, and does not last long (< 2 years); and allogenic cornea transplantation is impossible since always rejected due to neovascularization.

A new way to treat these patients is to cultivate autologous corneal-like epithelium, and to graft it in order to restore transparency and to allow, if needed, a complementary corneal graft. Such an epithelium can be produced from autologous jugal mucosa cells. Epithelial jugal mucosa sheets transplantation has been assessed in a phase I/II clinical trial on 26 patients which showed that it is well-tolerated and effective but the culture technology used in this clinical trial is no longer available. A new enzymatic detachment process has been developed by the Hospices Civils de Lyon. Proof of concept was obtained from both in vitro and ex vivo studies: detachment with Collagenase at 0.5 mg/mL doesn't damage basement membrane proteins, so collagenase 0.5mg/mL-detached FEMJA were found to adhere, continue to ensure renewal of the differentiated epithelium 15 days after grafting onto an ex vivo porcine de-epitheliazed stroma model.

Considering these results, we aim to perform a clinical trial in order to evaluate tolerance and efficacy of the autologous jugal mucosa cell sheet (Feuillets Epithéliaux de Muqueuse Jugale Autologue - FEMJA) cultured with this innovative process.

location_facility: Ophthalmology department, Edouard Herriot hospital, Hospices Civils de Lyon


title: Follow up to the AVANT Study up to 8 and 10 Years (Median Follow up) in Patients With Colon Carcinoma

summary:
The aim of the S-AVANT study is to collect additional data at 8 and 10 years median follow up of patients previously included in the AVANT trial from December 2004 to June 2007.

Clinical data of the AVANT trial will be updated. Neither additional examination nor administration of any treatment will be performed on the patients.

330 centers in 34 countries participated to the AVANT trial (Australia, Austria , Belgium, Brazil, Bulgaria, Canada, China/Hong-Kong, Czeck Republic, Finland, France, Germany, Greece, Hungary, Israël, Italy, Japan, Korean Republic, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taïwan, Thaïland, United Kingdom, U.S.A).

The AVANT study aiming at demonstrating superiority of bevacizumab in combination with FOLFOX-4 or XELOX compared to FOLFOX-4, did not show prolongation of DFS at 3 year when adding bevacizumab to chemotherapy in resected stage III colon cancer.

Adverse events were consistent with the known safety profile of bevacizumab. However, more relapses and deaths due to disease progression have been observed in both bevacizumab arms.

A more prolonged follow-up is necessary to assess overall survival and to evaluate long-term results and safety.

Collection of additional follow-up data will start Q3 2014. Clinical data are to be collected at 8-year median follow-up (expected to be reached around Q2 2014) and at 10-year median follow-up (expected to be reached around Q2 2016).

All analyses will be performed on an exploratory purpose only. An analysis at 8 years median follow-up and a final analysis at 10 years median follow-up will be performed in the main population (all randomized patients in the AVANT trial including patients lost to follow up or died).

time_perspective: Other

ReferenceCitation: Chibaudel B, Henriques J, Rakez M, Brenner B, Kim TW, Martinez-Villacampa M, Gallego-Plazas J, Cervantes A, Shim K, Jonker D, Guerin-Meyer V, Mineur L, Banzi C, Dewdney A, Dejthevaporn T, Bloemendal HJ, Roth A, Moehler M, Aranda E, Van Cutsem E, Tabernero J, Schmoll HJ, Hoff PM, André T, de Gramont A. Association of Bevacizumab Plus Oxaliplatin-Based Chemotherapy With Disease-Free Survival and Overall Survival in Patients With Stage II Colon Cancer: A Secondary Analysis of the AVANT Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2020425. doi: 10.1001/jamanetworkopen.2020.20425. Erratum in: JAMA Netw Open. 2021 Feb 1;4(2):e210700.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group


type: Registry Identifier

title: Creation of a Shared Medical Decision-making Tool for Atopic Dermatitis

acronym: SHADOW

summary:
Hypothesis/Objective : Patient-centered health care and shared decision making are key components of increasing importance which are recommended by the French Haute Autorite de Sante (HAS) and World Health Organization (WHO).

In the context of dermatology and atopic dermatitis, European guidelines has promoted an active involvement from both patients and caregivers in therapeutic decisions at all stages to achieve therapeutic success and the Task Force on Atopic Dermatitis (ETFAD) has promoted the setting of treatment goals in a shared decision with the patient.

The main objective of this study is to develop and cross culturally validate a tool dedicated to shared-decision in atopic dermatitis that can be used during routine dermatological consultations.

The second objective is to better characterize patients seen in this context and to evaluate patients' satisfaction when empowered by shared decision.

Method : We aim to develop a SDMt in AD following the recommendations of the International Patient Decision Aid Standards (IPDAS) collaboration. Development will use a multistep approach: 1) identification of priority domains for patients; 2) Selection of domains to be included in the SDMt for AD; and 3) Creation and testing of the SDMt.

Participants will be consecutive adult (>18 years old) patients attending consultation for a AD in medical centres in France (Toulouse, Nantes and Créteil). All participants will provide written consent to participate. The study will be submitted for approbation to the local ethics committees of the University Hospital Centres of Paris and will be conducted according to the Declaration of Helsinki.

Step 1: Identification of priority domains for patients

Step 2: Selection of domains to be included in the SDMt for AD

Step 3: Creation and testing of the SDMt

ipd_sharing_description: APHP IS DATA'S OWNER, PLEASE CONTACT BOARD


title: Assessment of the Effects of Early Proprioceptive Stimulations in Patients With Severe Traumatic Brain Injury : a Randomized Controlled Trial

acronym: TC-Mouv

summary:
"Severe traumatic brain injury (TBI) is a serious condition, common in young adults. It leads to sensorimotor and cognitive sequelae that hinder social reintegration. Neuronal plasticity must be used quickly before natural recovery impedes neuronal regrowth. In this respect, stopping sedation as soon as possible and early mobilization, even if the patients are unconscious, are recognized as useful measures to promote recovery. However, at the early stage, the environment of the ICU and the acute condition of the patients limit the rehabilitation possibilities. In such a context, functional proprioceptive stimulations (Vibramoov™ system, Techno Concept, France) could be a tool of interest.

By using the proprioceptive signatures of cyclic movements, proprioceptive stimulations can elicit the illusion of these movements. A motor response can even be obtained through the interactions between the peripheral nervous system and the central nervous system. Finally, such stimulations facilitate the initiation of the mimicked movements. Some studies have already shown the benefits of proprioceptive vibrations. However, so far, these benefits have only been studied at the chronic stage of neurological diseases. The investigators hypothesized that early functional proprioceptive stimulations (FPS) may reduce spasticity and promote recovery in patients with severe traumatic brain injury.

To test the hypothesis, the investigators conduct a randomized controlled trial on patients with severe traumatic brain injury. Every patient will be included as soon as possible in the ICU and receive either FPS, either sham stimulations to the joints of the lower limbs, 4 times a week during 8 weeks. The primary outcome measures will assess spasticity. The investigators also assess pain, coma recovery; muscle wasting and cognitive impairments. "


title: Surveillance of Invasive Pneumococcal Infections in Adults (Excluding Meningitis)

acronym: SIIP

summary: Given the frequency and severity of invasive pneumococcal infections and questions about the place of VPC-13 in the prevention of pneumococcal infections in adults based on the presence of risk factors, current laboratory surveillance should be supplemented with data on the clinical features of adult invasive pneumococcal infections (IPI) cases. In particular it is necessary to collect for these cases, the clinical forms, the severity and the existence of risk factors and to make the link between these characteristics and those strains of pneumococci responsible for the IPI in particular, their serotype. The follow-up of the evolution of the cases according to the presence of risk factors, their clinical form and their serotype coverage (vaccine strain or not) must to guide recommendations for adult VPC-13 and to monitor the effects of VPC-13 vaccination recommendations. These effects are indirect, linked to the effect of vaccination of children with VPC-13 since 2010, which modifies the serotypes responsible for infections in vaccinated and unvaccinated patients, and the direct effects of possible use of the conjugate vaccine in adults (according to the recommendations that will be given by the Vaccination Technical Committee of the High Council of Public Health). The project is based on the existing network of 23 Regional Pneumococcal Observatories (ORP) located in metropolitan France and the network of infectious diseases by completing the microbiological collection of strains of pneumococci isolated from invasive infections in adults by a clinical collection in hospitals or voluntary clinics where the laboratory participates in the ORP. Given the establishment in 2012 of an adult bacterial meningitis observatory, to which the ORP are associated, this project does not include the surveillance of pneumococcal meningitis in adults.


title: Characterization and Prognostic Impact of Inflammatory Responses by Host Transcriptomics and Co-infection by Metagenomics in Patients With ARDS COVID-19 in Intensive Care

acronym: COMETS

summary:
Pandemic SARS-CoV-2 (COVID-19) respiratory infection is responsible for more than 4,000 deaths, mainly (67%) secondary to acute respiratory distress syndromes (ARDS). ARDS is usually associated with a mortality of around 40%, but this rate reaches 61% in patients infected with SARS-CoV-2. Two endotypes have been described in patients with ARDS: one, hyper-inflammatory, associated with very high mortality (51%); the second, slightly inflammatory (immunoparalysis), associated with much lower mortality (19%). In COVID-19 patients, distinct immune response profiles have also been observed. Some patients present deep lymphopenia and/or prolonged viral excretions associated with more frequent occurrence of co-infections (+ 29% of virus, + 23% of bacteria, + 10% of fungi). The latter group may be at higher risk in terms of mortality. The intensity of the inflammatory response and/or microbial coinfections therefore appear as risk factors for severity and mortality in patients infected with SARS-CoV-2 which determine the course of the disease. To adapt early optimal therapeutic management to each forms of the disease, it is essential to be able to characterize these profiles on the microbiological and inflammatory level.

With a committed network of 6 intensive-care units across eastern and northern Ile-de-France, 180 patients with ARDS and infected with SARS-CoV-2 are being enrolled. For these patients, a nasopharyngeal swab is collected at inclusion; followed by a new nasopharyngeal swab and a deep respiratory sample once a week, until D28, for an exploration of co-infections and for monitoring the viral load of SARS-CoV-2. The rest of each of these samples are collected for the study. In parallel, the clinical data usually collected in the context of intensive care will be collected on a CRF. They will allow to calculate risk scores such as SOFA.


title: Evaluation of a SARS-CoV-2 Infectious Risk Management Protocol on the Transmission of Nosocomial COVID in Intensive Care Unit"

acronym: NOSOCOVID

summary:
The current global pandemic at COVID-19 is a major public health issue. Transmission of the virus is primarily through direct and close person-to-person contact. The protection of health care personnel and the limitation of transmission of nosocomial COVID is paramount. Protective measures have already shown their effectiveness in limiting the spread of the virus: the use of masks, the wearing of protective gowns, the wearing of protective eyewear, social and physical distancing. A recent U.S. study (Rhee et al. JAMA 2020) reported a very low incidence of 1.7% of nosocomial COVID, but this was achieved with the application of rigorous infection risk management protocols. In addition to the widespread use of masks and protective measures, dedicated COVID units had been created, with air treatment. The implementation of these dedicated units requires the mobilization of considerable human and material resources, which is not feasible in all hospitals over the long term.

In view of the second wave of the epidemic in France, with the rising numbers of new cases of COVDI-19 admitted to intensive care units since the end of the summer 2020, it is essential to organize the intensive care units to ensure the protection of personnel and limit the risk of nosocomial COVID-19, while continuing to care for non-COVID patients.

In Intensive Care unit (ICU) at the Nantes University Hospital, a strict protocol for the management of suspected or confirmed COVID patients has been in place since early september 2020. The objective of this study is to evaluate the effectiveness of this protocol for managing the infectious risk of SARS-COV-2 on the incidence of nosocomial COVID in patients admitted in ICU. The secondary objectives are to evaluate the incidence of nosocomial-associated COVIDs contracted by caregivers, and the incidence of asymptomatic positive SARS-CoV-2 cases in ICU.

lead_sponsor: Nantes University Hospital


title: Patient-caregiver Collaboration for Better Cardiovascular Care for Patients With Long-term Mental Disorders: Multicentre Qualitative and Feasibility Studies

acronym: COPsyCAT

summary:
People with severe and persistent mental disorders (or SMI, Severe Mental Illness) have a life expectancy which is 20 years less than the general population, mainly due to excess mortality related to cardiovascular disease. Moreover, despite an overall increase in life expectancy, the gap is widening between people with long-term psychological disorders and the general population.

This early excess mortality is explained by disparities between people with SMI and the general population not only in access to and use of health services but also in the quality and type of care provided. There is also an over-representation of risk factors and cardiovascular pathologies regardless of the mental disorder, despite the current recommendations for best practices.

The World Health Organization has defined the fight against somatic comorbidities as one of the axes of the European Mental Health Plan and one of the reference themes of the World Health Organization Mental Health Evidence and Research Programme (EPSM-Lille-Métropole). The Groupement de Coopération Sanitaire pour la recherche et la formation en santé mentale, which brings together 17 hospitals in France and relays the actions of the World Health Organization's Collaborating Centre, has decided to make it into a national research project.

Moreover, it is recognized that "medical" management of a disease is all the more effective when the patient is involved. However, the empowerment of people with long-term psychological disorders has never been put at the centre of a strategy to reduce cardiovascular risk.

In this context, we hypothesize that one of the keys to reducing cardiovascular risk would be to take into account the experience and representations of this risk by all stakeholders (people with long-term psychological disorders, their carers, primary health professionals and psychiatric professionals).

ReferenceCitation: Baleige A, Besnard JF, Meunier-Beillard N, Demassiet V, Monnier A, Ouezini A, Lambert O, Charrel C, Mazas O, Oberlin J, Roelandt JL, Denis F. A collaboration between service users and professionals for the development and evaluation of a new program for cardiovascular risk management in persons with a diagnosis of severe mental illness: French multicenter qualitative and feasibility studies. Int J Ment Health Syst. 2019 Dec 27;13:74. doi: 10.1186/s13033-019-0331-6. eCollection 2019.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Analyses of Bone Marrow and Blood Samples From Healthy Volunteers: Focus on the redOx Metabolism - HEALTHOX

acronym: HEALTHOX

summary:
Oxidative stress is defined by an excess of reactive oxygen species (reactive oxygen species or ROS) in cells. ROS are essential to cell life (proliferation, differentiation), including kinase activity via inhibition of phosphatases. Very low levels of ROS are observed in quiescent cells, including hematopoietic stem cells. Conversely, an excess of ROS can induce DNA damage that may lead to the destruction of the cell.

The level of ROS in cells is the result of production (mainly the NADPHoxydase and the mitochondrial respiratory chain) and their disposal via antioxidant enzymes. The hematology team of the university hospital of Tours (France) found that certain antioxidant enzymes are essential for the self-renewal of normal and leukemic cells such as glutathione peroxidase-3 (Herault O et al, J Exp Med 2012, 209:895). Their expression is modified in hematological diseases (patent WO2012085188A1 / 2012-06-28 and FR1000267310 / 2014-11-27).

Age potentially affects the level of expression of antioxidant genes, since it was established a decrease in glutathione peroxidase activity in women over 65 years (Sara E, J Gerontol A Biol Sci Med Sci 2008 63: 505). The study HEALTHOX will determine the impact of age on the oxidative metabolism of normal hematopoietic cells, and in particular the expression of antioxidant genes. It will provide a reference for analyzing disturbances of oxidative metabolism in blood diseases. The main objective is the comparison of peripheral blood and bone marrow cells depending from 3 groups of healthy volunteers: 18-39 years, 40-59 years and 60-85 years. The level of ROS and the expression of genes encoding the major antioxidant enzymes involved in the regulation of oxidative stress will be studied. The secondary objectives are to create a cell bank (blood and marrow), a blood plasma bank and a cDNA library (blood and marrow) from healthy volunteers.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Tours

intervention_type: Procedure


title: Efficacy of Transcranial Magnetic Stimulation (TMS) in Smoking Cessation, Combining Withdrawal Stimulations Followed by Maintenance Stimulations to Prevent Relapse: a Single-center, Randomized, Controlled, Blinded Pilot Study

acronym: TABACSTIM 3

summary:
Smoking cessation is a public health priority. Tobacco is directly responsible for 75,000 deaths per year in France. Without help, less than 5% of smokers are still abstinent after 12 months of smoking cessation. The use of nicotine replacement therapy only increases the chances of successful smoking cessation by 2-3%.

Brain imaging research shows that the dorsolateral prefrontal cortex (DLPC) is involved in tobacco addiction. Disorders induced in the DLPC cause an irrepressible urge to smoke (craving) and largely explain relapse during smoking cessation.

Transcranial Magnetic Stimulation (TMS) could be a promising tool in the quest for an effective approach to smoking cessation. This technique is used for direct stimulation of the DLPC via a magnetic coil in order to reduce the cortical activity of the DLPC and thus to reduce cravings.

A first randomized controlled study using TMS was conducted at the University Hospital of Dijon in highly addicted smokers who had failed to quit with the usual withdrawal strategies. In this study, entitled Tabacstim 1, we found that the combination of nicotine substitutes (to reduce physical withdrawal symptoms) with 10 "attack" sessions of TMS (to reduce cravings) increased the rate of abstinence during the first 2 weeks of withdrawal (% abstinence = 88. However, in this study, the therapeutic effect of the nicotine-SMT combination was not prolonged once the stimuli were stopped. At 6 and 12 weeks from the start of withdrawal, abstinence rates in the active SMT and placebo SMT groups were no longer significantly different.

We therefore initiated a new study, entitled Tabacstim 2, to add maintenance brain stimulation to the Tabacstim 1 protocol after the "attack" sessions (this therapeutic scheme is classically used in the treatment of depression with TMS). This study started in July 2020 and will end very soon (71 inclusions completed out of the 78 expected).

In both Tabacstim 1 and Tabacstim 2, the stimulations are delivered at low frequency (1 Hz) on the right DLPC. However, a recently published meta-analysis shows that, in addictions, stimulations delivered at a high frequency (10 Hz) on the left DLPC appear to be more effective in reducing craving. But above all, another meta-analysis carried out by our team (in progress of publication), finds that excitatory stimulations (such as 10 Hz rTMS) on the left DLPC are very effective in maintaining smoking abstinence in the medium term (3 and 6 months), which does not seem to be the case for inhibitory stimulations (such as 1 Hz rTMS).

We therefore wish to carry out the Tabacstim 3 study, which only differs from Tabacstim 2 in two stimulation parameters: 10 Hz stimulations on the left DLPC instead of 1 Hz stimulations on the right DLPC. We therefore propose in Tabacstim 3 to use excitatory stimulations on the left instead of inhibitory stimulations on the right.

Tabacstim 3 could be more effective for prolonged smoking cessation than the 2 previous protocols.


title: Pediatric Out-of-hospital Cardiopulmonary Arrest, Current Status of Out-of-hospital Management, Predictive Factors of Mortality, Physicians' Attitudes, Training Perspectives : a Multicentric Retrospective Study.

acronym: Ped-CPA

summary:
The objective of this observational and retrospective study is to determine the predictive factors of in-hospital mortality following an out-of-hospital cardiopulmonary arrest (CPA) in the population under 18 years old. Data are collected from telephone calls and medical regulation records processed by the health call center of 2 french departments between January 1, 2019, and March 15, 2022. The medical records of the included patients will also be reread in order to obtain the patient's status at 30 days after the CPA.

Detailed description:

The literature reports numerous works evaluating the epidemiological characteristics of pediatric out-of-hospital cardiorespiratory arrest. An improvement in survival has been reported in the case of resuscitation guided by the operator in medical regulation before the arrival of the emergency services. Indeed, the regulation phase at the 15 center in France is of fundamental importance. Recent evolutions, notably with the creation of specific call-taking professions, show the importance attached to improving practices.

The population concerned is characterized by children under 18 years of age, victims of an extra-hospital cardiorespiratory arrest. It is a retrospective study over three years and three months, multicentric, from the emergency service (SAMU) 57 and 69.

The primary endpoint was the all-cause mortality at thirty days of the admission.

The case report form (CRF) will collect the main aspects of telephone management at the 15 centers, out-of-hospital management by the emergency teams, and the personal characteristics of the emergency physicians and out-of-hospital responders (gender, age, family situation, etc.). The medical management in the emergency department and the first stages of in-hospital management will also be analyzed. The patients included who are still alive will receive a notification of non-objection by mail.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Study of the Link Between Psychosocial Treatments and the Need of Pharmacological Treatments in Children With Attention Deficit Hyperactivity Disorder : a Retrospective Online Study for Parents

acronym: OPTIME-TDAH

summary:
The Attention Deficit and Hyperactivity Disorder (ADHD) is a frequent disorder in children and adolescents. The diagnosis is clinical with the input of several informants (child, family, teachers, …). ADHD is a risk factor for academic difficulties, school dropout, social isolation, injury, oppositional behaviour. In school-age children and adolescents having moderate to high or persistent impairment despite psycho-educational support and environmental modification, the first-line treatment is methylphenidate. Group or individual cognitive behavioural therapy for parents and/or children and adolescents is recommended for co-occurring disorders and persistent impairment. In France, the initiation of methylphenidate requires an annual hospital prescription by a paediatrician or psychiatrist, and a regular medical supervision (weight, heart rate, blood pressure, …). At least once a year, the indication of methyphenidate needs to be re-evaluated and confirmed at the hospital. In case of lack of efficiency and/or poor tolerance, therapeutic alternatives including non-psychostimulants should be considered.

A randomized controlled trial evaluated the dose of methylphenidate received over a period of 13 months. It was observed that the "combined treatment" group (methylphenidate + psychosocial treatments) received a lower average dose of methylphenidate than the "methylphenidate alone" group. These results are difficult to extrapolate to the general population, due to the study protocol (regular monitoring of ADHD symptoms with the aim of total remission).

For a global consideration of children's needs, it is important to better understand the interactions between these two therapeutic approaches.

To participate in the study, parents will have to complete an online questionnaire. This questionnaire contains anamnestic data collection, questionnaires to assess ADHD symptoms and parenting practices.

time_perspective: Cross-Sectional

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Comparison of ANCA and Anti-GBM Auto-antibodies Removal Kinetics Between Plasma Exchanges and Immunoadsorption in Patients With ANCA-associated Vasculitis or Anti-GBM Disease

acronym: CINEVAS

summary:
Anti-neutrophil cytoplasmic antibodies (ANCA), directed against myeloperoxidase (MPO) and against proteinase 3 (PR3), have a pathogenic role during ANCA (AAV) vasculitis. Glomerular basement membrane (MBG) antibodies also have a direct pathogenic role in Goodpasture's syndrome and anti-MBG antibody glomerulonephritis (GN). In some patients, the severity of renal and / or pulmonary involvement justifies the rapid purification of these autoantibodies by an apheresis procedure, while waiting for the effect of immunosuppressive treatments aimed at reducing their production. During vasculitis, plasma exchange (PE) is recommended in patients with severe renal impairment or intra-alveolar hemorrhage (2012 KDIGO Clinical Practice Guideline for Glomerulonephritis).

Given certain disadvantages related to plasma exchanges (low volume of purified plasma, non-selective technique for immunoglobulins (Ig), need for replacement solute, induction of coagulation disorders), immunoadsorption (IA), already used in transplantation, has been developed in these indications. IA has indeed greater selectivity for Ig with a probable better purification capacity due to higher volumes of plasma treated per session. The price of IA is however higher than that of EP.

These two apheresis techniques, EP and IA, are commonly used in France during severe forms of vasculitis ANCA or anti-MBG, without the superiority of one or the other has been demonstrated. As a result of higher plasma volumes being purified, AI may allow faster purification of pathogenic antibodies. No studies to date have specifically compared the purification kinetics of these antibodies between EP and IA.

The CINEVAS study (VAScularite Antibody Purification CINetic) is a multicentric pilot study whose main objective is to compare the purification kinetics of ANCA (anti-MPO or anti-PR3) and / or anti- MBG in patients treated with EP versus those treated with IA

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assisatance Publique Hôpitaux de Marseille


title: Evaluation of Falls Occurring at Home in People Over 75 Equipped or Non-equipped With a Precocious Detection Device. Prospective Interventional Study.

summary: The objective of this study is to evaluate the evolution 6 months after a fall occurring at home in people over 75 equipped or non-equipped with a precocious detection device. The possibility to establish a relation between the alert emitted by the device, the time separating the fall from the arrival at hospital and the potential consequences for the persons will be analyzed with the greatest accuracy. Besides, the sequences of intervention of the different operators will be described with precision. 200 persons living at home in the ESSONNE(France)and having fallen at least one time during the previous 3 months will be included in the study and two groups of 100 will be constituted randomly after having signed a written consent. Of the 2 groups, one will be constituted with persons equipped with a precocious fall detection device named Vigi'Fall® , the second being non-equipped. After a first visit checking that the inclusion criteria are abide by and the installation of the device in the persons designated randomly for being equipped, a second visit will be carried out after 10 months in order to know the evolution, i.e. if the persons are still alive, living at home or having left for admission in an institution (hospital, nursing home, retirement home...). By a detailed comparison between the 2 groups, it will be possible to evaluate the potential interest of having been equipped or non-equipped with a precocious fall detection device. Hence, a change in practices may lead to a prevision of elderly persons likely to benefit of a precocious detection device and to the development of prevention in hospital geriatric departments, geriatric care networks, emergency departments and local services for the elderly and disabled. Another possible gain of the study is to sensitize the medical, paramedical and social teams to the usefulness of precocious detection devices in elderly subjects at risk for falls.

status: Terminated

primary_purpose: Prevention


type: Other Grant/Funding Number

title: ADNEXMR Scoring System: Impact of an MR Scoring System on Therapeutic Strategy of Pelvic Adnexal Masses

summary:
Background : About 25% of adnexal masses remain indeterminate after transvaginal ultrasonography, as evidenced by the published literature. According to a multicenter study conducted in France by Huchon et al., surgery is mainly indicated based on tumor size and ultrasonographic appearances and a high rate of benignity is finally found at pathology (83.3%). MRI is the most accurate second-line imaging technique for characterizing adnexal masses with an accuracy>95%. However, among physicians, a debate exists on the relevance of MR imaging to characterize adnexal masses possibly due to the absence of standardization of the MR report. In 2013, the first MR scoring system for adnexal masses named "ADNEXMR score" was developed and found to be accurate, with an AUROC>0.94 to distinguish benign from malignant adnexal masses. Indeed, our hypothesis is that ADNEXMR score that relays the radiologist's suspicion of malignancy to clinician has the potential aim of improving patient management, in particular by limiting the number of patients undergoing inappropriate surgery.

Main objective: To compare the rate of inappropriate surgery that occurs when patients are managed according to the therapeutic strategy based on ADNEXMR score with the therapeutic strategy performed in clinical routine.

Primary endpoint: The rate of inappropriate surgical intervention during the two first months after MR imaging (i.e. unnecessary diagnostic surgery for benign lesions and incomplete staging for borderline or invasive cancer).

Study design:

The study is a prospective multicenter randomized diagnostic study. 606 patients will be included by 9 hospitals (17 centers).
Total duration of the study is 56 months with 32 months for patient inclusions.
At D0, following informed written consent, patients will be randomized in one of two groups (intervention group or control group). In the intervention group, patients will undergo a pelvic MR imaging (1.5T or 3T) as routinely performed, including morphological sequences (T2, T1 with and without fat suppression and T1 after dynamic gadolinium injection) and functional sequences (perfusion and diffusion-weighted sequences). Prospectively, a senior radiologist analyzes the different MR criteria to characterize adnexal masses. The reader will classify the mass using ADNEXMR SCORING system and the patient will be managed according to the score. In control group, the complex adnexal mass will be managed according to the standard strategy and treatment plan routinely used by the multidisciplinary team. Clinical, biological, ultrasonographic and/or MR data and the type of treatment will be recorded. If a surgery is required, surgical procedure will be performed within the two months after initial diagnostic imaging (as routinely recommended).

At M6/M12, follow-up will be performed. If the lesion has increased or changed with suspicious criteria, surgery will be performed as routinely recommended in both groups.

At M24, adnexal masses status will be recorded by clinical and imaging follow up.

ReferenceType: result

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