title: A Randomized Multicenter Phase III Trial Evaluating the Interest of Imatinib Treatment Maintenance or Interruption After 3 Years of Adjuvant Treatment in Patients With Gastrointestinal Stromal Tumours (GIST)

acronym: ImadGist

summary:
This is a 2 arms study concerning patients with primary GIST who followed an Imatinib adjuvant treatment for 3 years after surgery and who have a high risk of recurrence.

In the first arm, patients will continue Imatinib treatment for 3 more years, allowing to determine if the continuation of this treatment is efficient for disease control, in terms of Disease Free Survival improvement.

In the second arm, patients will discontinue the Imatinib treatment, as standard practice. This arm will allow to determine if the re-introduction of Imatinib at relapse is still an efficient treatment for the control of disease.

ReferenceCitation: Blackstein ME, Blay JY, Corless C, Driman DK, Riddell R, Soulieres D, Swallow CJ, Verma S; Canadian Advisory Committee on GIST. Gastrointestinal stromal tumours: consensus statement on diagnosis and treatment. Can J Gastroenterol. 2006 Mar;20(3):157-63. doi: 10.1155/2006/434761.

ReferenceCitation: Blanke CD, Demetri GD, von Mehren M, Heinrich MC, Eisenberg B, Fletcher JA, Corless CL, Fletcher CD, Roberts PJ, Heinz D, Wehre E, Nikolova Z, Joensuu H. Long-term results from a randomized phase II trial of standard- versus higher-dose imatinib mesylate for patients with unresectable or metastatic gastrointestinal stromal tumors expressing KIT. J Clin Oncol. 2008 Feb 1;26(4):620-5. doi: 10.1200/JCO.2007.13.4403.

ReferenceCitation: Blanke CD, Rankin C, Demetri GD, Ryan CW, von Mehren M, Benjamin RS, Raymond AK, Bramwell VH, Baker LH, Maki RG, Tanaka M, Hecht JR, Heinrich MC, Fletcher CD, Crowley JJ, Borden EC. Phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors expressing the kit receptor tyrosine kinase: S0033. J Clin Oncol. 2008 Feb 1;26(4):626-32. doi: 10.1200/JCO.2007.13.4452.

ReferenceCitation: Blay JY, von Mehren M, Blackstein ME. Perspective on updated treatment guidelines for patients with gastrointestinal stromal tumors. Cancer. 2010 Nov 15;116(22):5126-37. doi: 10.1002/cncr.25267.

ReferenceCitation: Blay JY, Le Cesne A, Ray-Coquard I, Bui B, Duffaud F, Delbaldo C, Adenis A, Viens P, Rios M, Bompas E, Cupissol D, Guillemet C, Kerbrat P, Fayette J, Chabaud S, Berthaud P, Perol D. Prospective multicentric randomized phase III study of imatinib in patients with advanced gastrointestinal stromal tumors comparing interruption versus continuation of treatment beyond 1 year: the French Sarcoma Group. J Clin Oncol. 2007 Mar 20;25(9):1107-13. doi: 10.1200/JCO.2006.09.0183.

ReferenceCitation: Casali PG, Jost L, Reichardt P, Schlemmer M, Blay JY; ESMO Guidelines Working Group. Gastrointestinal stromal tumors: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol. 2008 May;19 Suppl 2:ii35-8. doi: 10.1093/annonc/mdn080. No abstract available.

ReferenceCitation: ClinicalTrials.gov. Imatinib mesilate or observation only in treating patients who have undergone surgery for localized gastrointestinal stromal tumor. NCT identifier: NCT00103168. 13-12-2009. Ref Type: Online Source

ReferenceCitation: ClinicalTrials.gov. Five year adjuvant imatinib mesilate (Gleevec®) in gastrointestinal stromal tumor (GIST). NCT Identifier: NCT00867113. 24-8-2011. Ref Type: Online Source

ReferenceCitation: Corless CL, Heinrich MC. Molecular pathobiology of gastrointestinal stromal sarcomas. Annu Rev Pathol. 2008;3:557-86. doi: 10.1146/annurev.pathmechdis.3.121806.151538.

ReferenceCitation: Corless CL, Barnett CM, Heinrich MC. Gastrointestinal stromal tumours: origin and molecular oncology. Nat Rev Cancer. 2011 Nov 17;11(12):865-78. doi: 10.1038/nrc3143.

ReferenceCitation: Dematteo RP, Ballman KV, Antonescu CR, Maki RG, Pisters PW, Demetri GD, Blackstein ME, Blanke CD, von Mehren M, Brennan MF, Patel S, McCarter MD, Polikoff JA, Tan BR, Owzar K; American College of Surgeons Oncology Group (ACOSOG) Intergroup Adjuvant GIST Study Team. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial. Lancet. 2009 Mar 28;373(9669):1097-104. doi: 10.1016/S0140-6736(09)60500-6. Epub 2009 Mar 18. Erratum In: Lancet. 2009 Aug 8;374(9688):450.

ReferenceCitation: DeMatteo RP, Lewis JJ, Leung D, Mudan SS, Woodruff JM, Brennan MF. Two hundred gastrointestinal stromal tumors: recurrence patterns and prognostic factors for survival. Ann Surg. 2000 Jan;231(1):51-8. doi: 10.1097/00000658-200001000-00008.

ReferenceCitation: Dematteo RP, Heinrich MC, El-Rifai WM, Demetri G. Clinical management of gastrointestinal stromal tumors: before and after STI-571. Hum Pathol. 2002 May;33(5):466-77. doi: 10.1053/hupa.2002.124122.

ReferenceCitation: Demetri GD, von Mehren M, Blanke CD, Van den Abbeele AD, Eisenberg B, Roberts PJ, Heinrich MC, Tuveson DA, Singer S, Janicek M, Fletcher JA, Silverman SG, Silberman SL, Capdeville R, Kiese B, Peng B, Dimitrijevic S, Druker BJ, Corless C, Fletcher CD, Joensuu H. Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N Engl J Med. 2002 Aug 15;347(7):472-80. doi: 10.1056/NEJMoa020461.

ReferenceCitation: Demetri GD, von Mehren M, Antonescu CR, DeMatteo RP, Ganjoo KN, Maki RG, Pisters PW, Raut CP, Riedel RF, Schuetze S, Sundar HM, Trent JC, Wayne JD. NCCN Task Force report: update on the management of patients with gastrointestinal stromal tumors. J Natl Compr Canc Netw. 2010 Apr;8 Suppl 2(0 2):S1-41; quiz S42-4. doi: 10.6004/jnccn.2010.0116.

ReferenceCitation: Patrikidou A, Chabaud S, Ray-Coquard I, Bui BN, Adenis A, Rios M, Bertucci F, Duffaud F, Chevreau C, Cupissol D, Domont J, Perol D, Blay JY, Le Cesne A; French Sarcoma Group. Influence of imatinib interruption and rechallenge on the residual disease in patients with advanced GIST: results of the BFR14 prospective French Sarcoma Group randomised, phase III trial. Ann Oncol. 2013 Apr;24(4):1087-93. doi: 10.1093/annonc/mds587. Epub 2012 Nov 21.

ReferenceCitation: Gold JS, Gonen M, Gutierrez A, Broto JM, Garcia-del-Muro X, Smyrk TC, Maki RG, Singer S, Brennan MF, Antonescu CR, Donohue JH, DeMatteo RP. Development and validation of a prognostic nomogram for recurrence-free survival after complete surgical resection of localised primary gastrointestinal stromal tumour: a retrospective analysis. Lancet Oncol. 2009 Nov;10(11):1045-52. doi: 10.1016/S1470-2045(09)70242-6. Epub 2009 Sep 28.

ReferenceCitation: H.Joensuu, M.Eriksson, J.Hatrmann, K.Sundby Hall, J.Schutte, A. Reichardt, M.Schlemmer, E. Wardelmann, G.Ramadori, S. E. Al-Batran B. E. Nilsson O. Monge R. Kallio, and M.Sarlomo-Rikala, P. Bono M. Leinonen P. Hohenberger T. Alvegard P. Reichardt. Three years of imatinib improves survival for high-risk gastrointestinal stromal tumours. ASCO 2011 . 2011. Ref Type: Abstract

ReferenceCitation: Heinrich MC, Corless CL, Demetri GD, Blanke CD, von Mehren M, Joensuu H, McGreevey LS, Chen CJ, Van den Abbeele AD, Druker BJ, Kiese B, Eisenberg B, Roberts PJ, Singer S, Fletcher CD, Silberman S, Dimitrijevic S, Fletcher JA. Kinase mutations and imatinib response in patients with metastatic gastrointestinal stromal tumor. J Clin Oncol. 2003 Dec 1;21(23):4342-9. doi: 10.1200/JCO.2003.04.190.

ReferenceCitation: Hirota S, Isozaki K, Moriyama Y, Hashimoto K, Nishida T, Ishiguro S, Kawano K, Hanada M, Kurata A, Takeda M, Muhammad Tunio G, Matsuzawa Y, Kanakura Y, Shinomura Y, Kitamura Y. Gain-of-function mutations of c-kit in human gastrointestinal stromal tumors. Science. 1998 Jan 23;279(5350):577-80. doi: 10.1126/science.279.5350.577.

ReferenceCitation: Jiang WZ, Guan GX, Lu HS, Yang YH, Kang DY, Huang HG. Adjuvant imatinib treatment after R0 resection for patients with high-risk gastrointestinal stromal tumors: a median follow-up of 44 months. J Surg Oncol. 2011 Dec;104(7):760-4. doi: 10.1002/jso.22010. Epub 2011 Jun 28.

ReferenceCitation: Joensuu,H. and Ericksson,M.H.J. (2011). Twelve versus 36 monts of adjuvant imatinib as treatment of operable GIST with high risk of recurrence: Final results of a randomized trial (SSGXVIII/AIO). J. Clin. Oncol.

ReferenceCitation: Joensuu H, Vehtari A, Riihimaki J, Nishida T, Steigen SE, Brabec P, Plank L, Nilsson B, Cirilli C, Braconi C, Bordoni A, Magnusson MK, Linke Z, Sufliarsky J, Federico M, Jonasson JG, Dei Tos AP, Rutkowski P. Risk of recurrence of gastrointestinal stromal tumour after surgery: an analysis of pooled population-based cohorts. Lancet Oncol. 2012 Mar;13(3):265-74. doi: 10.1016/S1470-2045(11)70299-6. Epub 2011 Dec 6.

ReferenceCitation: Le Cesne,A., Ray-Coquard,I.L., Bui Nguyen,B., Adenis,A., Rios,M., Bertucci,F., Duffaud,F., Cupissol,D., Chevreau,C., Bompas,E., Cioffi,A., Chabaud,S., Perol,D., and Blay,J. (2011). Time to secondary resistance (TSR) after interruption of imatinib (IM) in advanced GIST: Updated results of the prospective French Sarcoma Group randomized phase III trial on long-term survival. ASCO Meeting Abstracts 29, 10015.

ReferenceCitation: Le Cesne A, Ray-Coquard I, Bui BN, Adenis A, Rios M, Bertucci F, Duffaud F, Chevreau C, Cupissol D, Cioffi A, Emile JF, Chabaud S, Perol D, Blay JY; French Sarcoma Group. Discontinuation of imatinib in patients with advanced gastrointestinal stromal tumours after 3 years of treatment: an open-label multicentre randomised phase 3 trial. Lancet Oncol. 2010 Oct;11(10):942-9. doi: 10.1016/S1470-2045(10)70222-9. Epub 2010 Sep 21.

ReferenceCitation: Pisters PW, Colombo C. Adjuvant imatinib therapy for gastrointestinal stromal tumors. J Surg Oncol. 2011 Dec;104(8):896-900. doi: 10.1002/jso.22002.

ReferenceCitation: Ray-Coquard,I.L., Bin Bui,N., Adenis,A., Rios,M., Bertucci,F., Chabaud,S., Perol,D., Blay,J., Le Cesne,A., and Groupe Sarcome Francais & Groupe d'Etude des Tumeurs Osseuses (GSF-GETO) (2010). Risk of relapse with imatinib (IM) discontinuation at 5 years in advanced GIST patients: Results of the prospective BFR14 randomized phase III study comparing interruption versus continuation of IM at 5 years of treatment: A French Sarcoma Group Study. ASCO Meeting Abstracts 28, 10032.

ReferenceCitation: Tryggvason G, Gislason HG, Magnusson MK, Jonasson JG. Gastrointestinal stromal tumors in Iceland, 1990-2003: the icelandic GIST study, a population-based incidence and pathologic risk stratification study. Int J Cancer. 2005 Nov 1;117(2):289-93. doi: 10.1002/ijc.21167.

ReferenceCitation: Tzen CY, Wang JH, Huang YJ, Wang MN, Lin PC, Lai GL, Wu CY, Tzen CY. Incidence of gastrointestinal stromal tumor: a retrospective study based on immunohistochemical and mutational analyses. Dig Dis Sci. 2007 Mar;52(3):792-7. doi: 10.1007/s10620-006-9480-y.

ReferenceCitation: Verweij J, Casali PG, Zalcberg J, LeCesne A, Reichardt P, Blay JY, Issels R, van Oosterom A, Hogendoorn PC, Van Glabbeke M, Bertulli R, Judson I. Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial. Lancet. 2004 Sep 25-Oct 1;364(9440):1127-34. doi: 10.1016/S0140-6736(04)17098-0.

lead_sponsor: Centre Leon Berard

location_facility: Institut de cancérologie LUCIEN NEUWIRTH

location_facility: Centre Régional de Lutte contre le Cancer de Montpellier

location_facility: Centre Hospitalier Universitaire La Timone

location_facility: Centre Hospitalier universitaire Robert Debré


title: Hypofractionated Stereotactic Radiation Treatments (SBRT) on Children, Teenagers and Young Adults Malignant Tumors

acronym: SBRT

summary: The purpose of this study is to evaluate the efficacy of hypofractionated stereotactic radiation treatments (SBRT) on children, teenagers and young adults malignant tumors.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Timmerman RD. An overview of hypofractionation and introduction to this issue of seminars in radiation oncology. Semin Radiat Oncol. 2008 Oct;18(4):215-22. doi: 10.1016/j.semradonc.2008.04.001. No abstract available.

ReferenceCitation: Rapport ANAES : Evaluation clinique et économique de la radiochirurgie intra cranienne en conditions stéréotaxique - Rapport ANAES/Service évaluation des technologies-évaluation économique: 2000.

ReferenceCitation: Rapport HAS : Radiothérapie extra crânienne en conditions stéréotaxiques - Décembre 2006: 2006.

ReferenceCitation: Maranzano E, Anselmo P, Casale M, Trippa F, Carletti S, Principi M, Loreti F, Italiani M, Caserta C, Giorgi C. Treatment of recurrent glioblastoma with stereotactic radiotherapy: long-term results of a mono-institutional trial. Tumori. 2011 Jan-Feb;97(1):56-61. doi: 10.1177/030089161109700111.

ReferenceCitation: Minniti G, Armosini V, Salvati M, Lanzetta G, Caporello P, Mei M, Osti MF, Maurizi RE. Fractionated stereotactic reirradiation and concurrent temozolomide in patients with recurrent glioblastoma. J Neurooncol. 2011 Jul;103(3):683-91. doi: 10.1007/s11060-010-0446-8. Epub 2010 Nov 5.

ReferenceCitation: Torok JA, Wegner RE, Mintz AH, Heron DE, Burton SA. Re-irradiation with radiosurgery for recurrent glioblastoma multiforme. Technol Cancer Res Treat. 2011 Jun;10(3):253-8. doi: 10.7785/tcrt.2012.500200.

ReferenceCitation: Zacharoulis S, Ashley S, Moreno L, Gentet JC, Massimino M, Frappaz D. Treatment and outcome of children with relapsed ependymoma: a multi-institutional retrospective analysis. Childs Nerv Syst. 2010 Jul;26(7):905-11. doi: 10.1007/s00381-009-1067-4. Epub 2009 Dec 29.

ReferenceCitation: Kano H, Yang HC, Kondziolka D, Niranjan A, Arai Y, Flickinger JC, Lunsford LD. Stereotactic radiosurgery for pediatric recurrent intracranial ependymomas. J Neurosurg Pediatr. 2010 Nov;6(5):417-23. doi: 10.3171/2010.8.PEDS10252.

ReferenceCitation: Liu AK, Foreman NK, Gaspar LE, Trinidad E, Handler MH. Maximally safe resection followed by hypofractionated re-irradiation for locally recurrent ependymoma in children. Pediatr Blood Cancer. 2009 Jul;52(7):804-7. doi: 10.1002/pbc.21982.

ReferenceCitation: Combs SE, Behnisch W, Kulozik AE, Huber PE, Debus J, Schulz-Ertner D. Intensity Modulated Radiotherapy (IMRT) and Fractionated Stereotactic Radiotherapy (FSRT) for children with head-and-neck-rhabdomyosarcoma. BMC Cancer. 2007 Sep 13;7:177. doi: 10.1186/1471-2407-7-177.

ReferenceCitation: Giller CA, Berger BD, Pistenmaa DA, Sklar F, Weprin B, Shapiro K, Winick N, Mulne AF, Delp JL, Gilio JP, Gall KP, Dicke KA, Swift D, Sacco D, Harris-Henderson K, Bowers D. Robotically guided radiosurgery for children. Pediatr Blood Cancer. 2005 Sep;45(3):304-10. doi: 10.1002/pbc.20267.

ReferenceCitation: Grabb PA, Lunsford LD, Albright AL, Kondziolka D, Flickinger JC. Stereotactic radiosurgery for glial neoplasms of childhood. Neurosurgery. 1996 Apr;38(4):696-701; discussion 701-2.

ReferenceCitation: Hodgson DC, Goumnerova LC, Loeffler JS, Dutton S, Black PM, Alexander E 3rd, Xu R, Kooy H, Silver B, Tarbell NJ. Radiosurgery in the management of pediatric brain tumors. Int J Radiat Oncol Biol Phys. 2001 Jul 15;50(4):929-35. doi: 10.1016/s0360-3016(01)01518-8.

ReferenceCitation: Chawla S, Schell MC, Milano MT. Stereotactic body radiation for the spine: a review. Am J Clin Oncol. 2013 Dec;36(6):630-6. doi: 10.1097/COC.0b013e31822dfd71.

ReferenceCitation: Lo SS, Sahgal A, Wang JZ, Mayr NA, Sloan A, Mendel E, Chang EL. Stereotactic body radiation therapy for spinal metastases. Discov Med. 2010 Apr;9(47):289-96.

ReferenceCitation: Siva S, MacManus M, Ball D. Stereotactic radiotherapy for pulmonary oligometastases: a systematic review. J Thorac Oncol. 2010 Jul;5(7):1091-9. doi: 10.1097/JTO.0b013e3181de7143.

ReferenceCitation: Fogh SE, Andrews DW, Glass J, Curran W, Glass C, Champ C, Evans JJ, Hyslop T, Pequignot E, Downes B, Comber E, Maltenfort M, Dicker AP, Werner-Wasik M. Hypofractionated stereotactic radiation therapy: an effective therapy for recurrent high-grade gliomas. J Clin Oncol. 2010 Jun 20;28(18):3048-53. doi: 10.1200/JCO.2009.25.6941. Epub 2010 May 17. Erratum In: J Clin Oncol. 2010 Sep 20;28(27):4280.

ReferenceCitation: Flannery T, Kano H, Martin JJ, Niranjan A, Flickinger JC, Lunsford LD, Kondziolka D. Boost radiosurgery as a strategy after failure of initial management of pediatric primitive neuroectodermal tumors. J Neurosurg Pediatr. 2009 Mar;3(3):205-10. doi: 10.3171/2008.11.PEDS08268.

ReferenceCitation: Conter C, Carrie C, Bernier V, Geoffray A, Pagnier A, Gentet JC, Lellouch-Tubiana A, Chabaud S, Frappaz D. Intracranial ependymomas in children: society of pediatric oncology experience with postoperative hyperfractionated local radiotherapy. Int J Radiat Oncol Biol Phys. 2009 Aug 1;74(5):1536-42. doi: 10.1016/j.ijrobp.2008.09.051. Epub 2009 Apr 11.

ReferenceCitation: Massimino M, Gandola L, Giangaspero F, Sandri A, Valagussa P, Perilongo G, Garre ML, Ricardi U, Forni M, Genitori L, Scarzello G, Spreafico F, Barra S, Mascarin M, Pollo B, Gardiman M, Cama A, Navarria P, Brisigotti M, Collini P, Balter R, Fidani P, Stefanelli M, Burnelli R, Potepan P, Podda M, Sotti G, Madon E; AIEOP Pediatric Neuro-Oncology Group. Hyperfractionated radiotherapy and chemotherapy for childhood ependymoma: final results of the first prospective AIEOP (Associazione Italiana di Ematologia-Oncologia Pediatrica) study. Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1336-45. doi: 10.1016/j.ijrobp.2003.08.030.

ReferenceCitation: Sharma MS, Kondziolka D, Khan A, Kano H, Niranjan A, Flickinger JC, Lunsford LD. Radiation tolerance limits of the brainstem. Neurosurgery. 2008 Oct;63(4):728-32; discussion 732-3. doi: 10.1227/01.NEU.0000325726.72815.22.

ReferenceCitation: Merchant TE, Boop FA, Kun LE, Sanford RA. A retrospective study of surgery and reirradiation for recurrent ependymoma. Int J Radiat Oncol Biol Phys. 2008 May 1;71(1):87-97. doi: 10.1016/j.ijrobp.2007.09.037.

location_facility: Institut de Cancérologie de l'Ouest René Gauducheau

intervention_type: Radiation

lead_sponsor_type: academique

status_simplified: Completed


title: Impact of ODYSight in the Management of patientS With imparairEd Visual acuitY (ODYSSEY).

acronym: ODYSSEY

summary: Previous investigations have demonstrated the agreement between OdySight® and standardised methods in the evaluation of near visual acuity. The app allows for remote monitoring of this parameter with tracking changes. In case of decrease in visual acuity, a notification is sent to both patient and ophthalmologist. The aim of this study is to evaluate the medical relevance of OdySight® features in the management of patients suffering from impaired visual acuity.

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Anticipated

ReferenceCitation: GBD 2019 Blindness and Vision Impairment Collaborators; Vision Loss Expert Group of the Global Burden of Disease Study. Causes of blindness and vision impairment in 2020 and trends over 30 years, and prevalence of avoidable blindness in relation to VISION 2020: the Right to Sight: an analysis for the Global Burden of Disease Study. Lancet Glob Health. 2021 Feb;9(2):e144-e160. doi: 10.1016/S2214-109X(20)30489-7. Epub 2020 Dec 1. Erratum In: Lancet Glob Health. 2021 Apr;9(4):e408.

ReferenceCitation: Claessens JLJ, Geuvers JR, Imhof SM, Wisse RPL. Digital Tools for the Self-Assessment of Visual Acuity: A Systematic Review. Ophthalmol Ther. 2021 Dec;10(4):715-730. doi: 10.1007/s40123-021-00360-3. Epub 2021 Jun 25. Erratum In: Ophthalmol Ther. 2021 Dec;10(4):731-732.

ReferenceCitation: Srinivasan K, Ramesh SV, Babu N, Sanker N, Ray A, Karuna SM. Efficacy of a remote based computerised visual acuity measurement. Br J Ophthalmol. 2012 Jul;96(7):987-90. doi: 10.1136/bjophthalmol-2012-301751. Epub 2012 Apr 26.

ReferenceCitation: Yeung WK, Dawes P, Pye A, Neil M, Aslam T, Dickinson C, Leroi I. eHealth tools for the self-testing of visual acuity: a scoping review. NPJ Digit Med. 2019 Aug 22;2:82. doi: 10.1038/s41746-019-0154-5. eCollection 2019. Erratum In: NPJ Digit Med. 2019 Nov 26;2:117.

ReferenceCitation: Williams AM, Kalra G, Commiskey PW, Bowers EMR, Rudolph BR, Pitcher MD, Dansingani KK, Jhanji V, Nischal KK, Sahel JA, Waxman EL, Fu R. Ophthalmology Practice During the Coronavirus Disease 2019 Pandemic: The University of Pittsburgh Experience in Promoting Clinic Safety and Embracing Video Visits. Ophthalmol Ther. 2020 Sep;9(3):1-9. doi: 10.1007/s40123-020-00255-9. Epub 2020 May 6.

ReferenceCitation: Tiraset N, Poonyathalang A, Padungkiatsagul T, Deeyai M, Vichitkunakorn P, Vanikieti K. Comparison of Visual Acuity Measurement Using Three Methods: Standard ETDRS Chart, Near Chart and a Smartphone-Based Eye Chart Application. Clin Ophthalmol. 2021 Feb 26;15:859-869. doi: 10.2147/OPTH.S304272. eCollection 2021.

ReferenceCitation: Miller JM, Jang HS, Ramesh D, Gonzalez Marshall MS, Yescas S, Harvey EM. Telemedicine distance and near visual acuity tests for adults and children. J AAPOS. 2020 Aug;24(4):235-236. doi: 10.1016/j.jaapos.2020.06.003. Epub 2020 Jul 30.

ReferenceCitation: Iskander M, Hu G, Sood S, Heilenbach N, Sanchez V, Ogunsola T, Chen D, Elgin C, Patel V, Wronka A, Al-Aswad LA. Validation of the New York University Langone Eye Test Application, a Smartphone-Based Visual Acuity Test. Ophthalmol Sci. 2022 Jun 15;2(3):100182. doi: 10.1016/j.xops.2022.100182. eCollection 2022 Sep.

ReferenceCitation: Kielwasser G, Kodjikian L, Dot C, Burillon C, Denis P, Mathis T. Real-Life Value of the Odysight(R) Application in At-Home Screening for Exudative Recurrence of Macular Edema. J Clin Med. 2022 Aug 26;11(17):5010. doi: 10.3390/jcm11175010.

ReferenceCitation: Guigou S, Michel T, Merite PY, Coupier L, Meyer F. Home vision monitoring in patients with maculopathy: Real-life study of the OdySight application. J Fr Ophtalmol. 2021 Jun;44(6):873-881. doi: 10.1016/j.jfo.2020.09.034. Epub 2021 May 20.

ReferenceCitation: Brucker J, Bhatia V, Sahel JA, Girmens JF, Mohand-Said S. Odysight: A Mobile Medical Application Designed for Remote Monitoring-A Prospective Study Comparison with Standard Clinical Eye Tests. Ophthalmol Ther. 2019 Sep;8(3):461-476. doi: 10.1007/s40123-019-0203-9. Epub 2019 Jul 25.

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Allen L, Thirunavukarasu AJ, Podgorski S, Mullinger D. Novel web application for self-assessment of distance visual acuity to support remote consultation: a real-world validation study in children. BMJ Open Ophthalmol. 2021 Sep 30;6(1):e000801. doi: 10.1136/bmjophth-2021-000801. eCollection 2021.

ipd_sharing: No

lead_sponsor: Tilak Healthcare

location_facility: Institut Ophtalmologique de l'Ouest Jules Verne

location_facility: Institut ophtalmologique Sourdille Atlantique

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Phase III Study to Evaluate the Quality of Life in Elderly Patients With Metastatic Colorectal Cancer Receiving First-line Therapy Based on Simplified Geriatric Parameters.

acronym: COLAGE

summary: A national, multicenter, open-label, randomized phase III study. The trial aim is to determine the best therapeutic strategies according with the HRQoL.

design_allocation: Randomized

primary_purpose: Other

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Hôpital des Diaconnesses Croix Saint Simon

intervention_type: Drug


title: Patient-reported Outcomes in Status Epilepticus Requiring Intensive Care Unit Management

acronym: POSEIDON

summary:
Status epilepticus (SE) is a common life-threatening neurological emergency in which prolonged or multiple closely spaced seizures can result in long-term impairments. SE remains associated with considerable mortality and morbidity, with little progress over the last three decades. The proportion of patients who die in the hospital is about 20% overall and 40% in patients with refractory SE. Morbidity is more difficult to evaluate, as adverse effects of SE are often difficult to differentiate from those attributed to the cause of SE. Our experience suggests that nearly 50% of patients may experience long-term functional impairments.

The precise description of the consequences of these functional impairments and their impact on quality of life after SE requiring intensive care management has been little studied.

Indeed, if cognitive, physical and mental impairments are now identified in the populations of patients who required intensive care under the term post-resuscitation syndrome (PICS), neuronal lesions consecutive to the SE itself or to its cause could be responsible for these different functional alterations. Thus, the following have been described: (i) cognitive disorders in the areas of attention, executive functions and verbal fluency, visual and working memory disorders, but also spatio-temporal disorders; (ii) physical disorders such as the so-called post-resuscitation polyneuromyopathy; and (iii) mental disorders such as anxiety disorders, depressive states or those related to post-traumatic stress.

Assessment and characterization of patient-reported outcomes is essential to complement the holistic assessment of clinically relevant outcomes from the patient's perspective. Here, we propose the development of a cross-sectional collection of PROs of the different constituents of PICs and HR-QOLs, and associated with functional patient outcomes, in those who required ICU management for status epilepticus.

status: Recruiting

time_perspective: Prospective

lead_sponsor: Versailles Hospital

location_facility:
CH de Roanne
CH de la Rochelle
CH de Brive la Gaillarde
CHVersailles
GH Sud Ile de France
GH Paris Saint Joseph
CHU de Dijon
CH de Toulon-La Seyne sur Mer
CHU de Nantes
Hôpital Claude Galien
CHU de Brest
CHU Henri Mondor
CH de Bethune
CH de Cannes
CH du Cotentin
CHU de Beaujon


lead_sponsor: PTC Therapeutics

summary: This study is designed to evaluate the safety and efficacy of deflazacort in participants with LGMD2I. Most participants enrolled will have a screening visit and 3 additional visits (after 1, 13, and 26 weeks of treatment).

location_facility: Washington University School of Medicine

location_facility: Rigshospitalet, University of Copenhagen

location_facility: Hugo W Moser Research Institute at Kennedy Krieger Institute

location_facility: Ludwig-Maximilians University Munich, Friedrich-Baur-Institute

location_facility: Pirogov Russian National Research Medical University

location_facility: Saint-Petersburg State Pediatric Medical University

location_facility: University of Iowa Hospitals and Clinics

status: Terminated

title: A Multicenter Open-Label Study on the Safety and Efficacy of Deflazacort (Emflaza) in Subjects With Limb-Girdle Muscular Dystrophy 2I (LGMD2I)

source: euctr

location_country:
Germany
Norway
Denmark
Sweden
United States
Canada
Russian Federation
France

status_simplified: Unknown


title: A Multicentre, Comparative, Placebo-controlled, Double-blinded, Phase II Study of the Efficacy of Lenvatinib in Patients With Locally Advanced or Metastatic GIST After Failure of Imatinib and Sunitinib

acronym: LENVAGIST

summary: The primary objective is to compare the efficacy of lenvatinib plus Best Supportive Care versus Placebo plus Best Supportive Care in the treatment of patients with advanced GIST, after failure of imatinib and sunitinib.

location_facility: Institut de Cancérologie de Lorraine Alexis Vautrin

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole


title: Aquagenic Pruritus in Myeloproliferative Neoplasms

acronym: PANAM

summary:
Description of the characteristics of aquagenic pruritus expressed by patients suffering from myeloproliferative neoplasms.

Prospective work based on the distribution of a dedicated questionnaire.

status: Unknown status

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


type: Other Identifier

title: Anger and Psychotrauma: Data From Military and Civilians

acronym: COPMiCiv

summary:
Post-Traumatic Stress Disorder (PTSD) is mainly associated with several emotions such as anger, guilt or shame. By interfering with psychotherapeutic work these emotions can be problematic. When suffering from PTSD, pervasive anger can also have relational consequences. Anger and PTSD are mutually reinforcing: anger can aggravate PTSD symptoms and aggressive behaviours, and conversely, PTSD promotes high levels of anger and aggression. A few explanatory hypotheses have been proposed. In terms of personality factors, anger-treatment may promote the severity of PTSD symptoms and the development of aggressive behaviours. In terms of stressors, exposure to combat and combat-related moral harms could play a role in the relationship between PTSD, anger and traumatic experiences over the course of life. Finally, in clinical terms, in the presence of PTSD, anger and aggressive behaviours may be triggered by substance abuse and depression.

Within the Anglo-Saxon literature, it is recognized that both civilians and military personnel with PTSD exhibit high levels of anger, with a possible predominance among military personnel. While we know that anger management mechanisms can be strongly influenced by cultural aspects and the type of event, there is no data in the French population.

This study proposes to fill in our knowledge of anger-PSTD relationships in the French population and by comparing civilian and military population.

ipd_sharing: Undecided

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Centre Hospitalier Léon-Jean Grégory de Thuir

location_facility: Centre régional psychotrauma Hauts-de-France

intervention_type: Behavioral


title: Effects of Home Pulmonary Rehabilitation in Patients With Chronic Respiratory Failure and Nutritional Depletion.

summary:
Title : Effects of home pulmonary rehabilitation in patients with chronic respiratory failure and nutritional depletion.

This is a randomized controlled, open clinical trial with two groups.

first group, 100 patients : control group, patients followed with no add-on intervention
Second group, 100 patients : rehabilitation group with education, oral supplements, exercise and androgenic steroids.

ReferenceCitation: Veale D, Chailleux E, Taytard A, Cardinaud JP. Characteristics and survival of patients prescribed long-term oxygen therapy outside prescription guidelines. Eur Respir J. 1998 Oct;12(4):780-4. doi: 10.1183/09031936.98.12040780.

ReferenceCitation: Ronning O. Alterations in craniofacial morphogenesis induced by parenterally administered papain. An experimental study on the rat. Suom Hammaslaak Toim. 1971;67:Suppl 3:3-96. No abstract available.

ReferenceCitation: Chailleux E, Fauroux B, Binet F, Dautzenberg B, Polu JM. Predictors of survival in patients receiving domiciliary oxygen therapy or mechanical ventilation. A 10-year analysis of ANTADIR Observatory. Chest. 1996 Mar;109(3):741-9. doi: 10.1378/chest.109.3.741.

ReferenceCitation: Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema. Report of the Medical Research Council Working Party. Lancet. 1981 Mar 28;1(8222):681-6.

ReferenceCitation: Okubadejo AA, Paul EA, Jones PW, Wedzicha JA. Does long-term oxygen therapy affect quality of life in patients with chronic obstructive pulmonary disease and severe hypoxaemia? Eur Respir J. 1996 Nov;9(11):2335-9. doi: 10.1183/09031936.96.09112335.

ReferenceCitation: Barnes PJ. Novel approaches and targets for treatment of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1999 Nov;160(5 Pt 2):S72-9. doi: 10.1164/ajrccm.160.supplement_1.17.

ReferenceCitation: Hunter AM, Carey MA, Larsh HW. The nutritional status of patients with chronic obstructive pulmonary disease. Am Rev Respir Dis. 1981 Oct;124(4):376-81. doi: 10.1164/arrd.1981.124.4.376.

ReferenceCitation: Schols AM, Soeters PB, Dingemans AM, Mostert R, Frantzen PJ, Wouters EF. Prevalence and characteristics of nutritional depletion in patients with stable COPD eligible for pulmonary rehabilitation. Am Rev Respir Dis. 1993 May;147(5):1151-6. doi: 10.1164/ajrccm/147.5.1151.

ReferenceCitation: Schols AM. Nutrition in chronic obstructive pulmonary disease. Curr Opin Pulm Med. 2000 Mar;6(2):110-5. doi: 10.1097/00063198-200003000-00005.

ReferenceCitation: Schols AM, Mostert R, Soeters PB, Greve LH, Wouters EF. Nutritional state and exercise performance in patients with chronic obstructive lung disease. Thorax. 1989 Nov;44(11):937-41. doi: 10.1136/thx.44.11.937.

ReferenceType: derived

ReferenceCitation: Pison CM, Cano NJ, Cherion C, Caron F, Court-Fortune I, Antonini MT, Gonzalez-Bermejo J, Meziane L, Molano LC, Janssens JP, Costes F, Wuyam B, Similowski T, Melloni B, Hayot M, Augustin J, Tardif C, Lejeune H, Roth H, Pichard C; IRAD Investigators. Multimodal nutritional rehabilitation improves clinical outcomes of malnourished patients with chronic respiratory failure: a randomised controlled trial. Thorax. 2011 Nov;66(11):953-60. doi: 10.1136/thx.2010.154922. Epub 2011 Jun 23.

lead_sponsor: University Hospital, Grenoble

collaborators: Societe Francophone de Nutrition Enterale et Parenterale

location_country: Switzerland France

location_facility: University Hospital Arnaud de Villeneuve

location_facility: Departement of Medicine, University Hospital of Genève


type: EudraCT Number

title: A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE)

acronym: EMBRACE

summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients of black race with systemic lupus erythematosus (SLE; lupus).

ReferenceCitation: Ellen Ginzler, Luiz Barbosa, David D'Cruz, Richard Furie, Kathleen Maksimowicz-McKinnon, James Oates, Mittermayer Barreto Santiago, Amit Saxena, Saira Sheikh, Damon Bass, Susan Burriss, Jennifer Gilbride, James Groark, Michelle Miller, Amy Pierce, David Roth, Beulah Ji. EMBRACE: Phase 3/4, Randomized, 52-Week Study of Belimumab Efficacy and Safety in Patients of Black African Ancestry With Systemic Lupus Erythematosus. Arthritis Rheumatol. 2021; DOI: 10.1002/art.41900 PMID: 34164944

doi: ellen

ReferenceCitation: Brunner HI, Abud-Mendoza C, Mori M, Pilkington CA, Syed R, Takei S, Viola DO, Furie RA, Navarra S, Zhang F, Bass DL, Eriksson G, Hammer AE, Ji BN, Okily M, Roth DA, Quasny H, Ruperto N. Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison. RMD Open. 2021 Sep;7(3):e001747. doi: 10.1136/rmdopen-2021-001747.

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

repositories_concat: PubMed Central;digitalcommons.wustl.edu

publisher_dissemination: British Medical Journal

ReferenceCitation: Ginzler E, Guedes Barbosa LS, D'Cruz D, Furie R, Maksimowicz-McKinnon K, Oates J, Santiago MB, Saxena A, Sheikh S, Bass DL, Burriss SW, Gilbride JA, Groark JG, Miller M, Pierce A, Roth DA, Ji B. Phase III/IV, Randomized, Fifty-Two-Week Study of the Efficacy and Safety of Belimumab in Patients of Black African Ancestry With Systemic Lupus Erythematosus. Arthritis Rheumatol. 2022 Jan;74(1):112-123. doi: 10.1002/art.41900. Epub 2021 Dec 9.

oa_host_type: repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: State University of New York - SUNY Open Access Repository (SOAR)

repositories_concat: PubMed Central;soar.suny.edu

unpaywall_oa_status: green

publisher_dissemination: Wiley

ipd_sharing_description: IPD for this study is available via the Clinical Study Data Request site

lead_sponsor: Human Genome Sciences Inc., a GSK Company

location_country:
Colombia
United Kingdom
Brazil
United States
South Africa
France


acronym: MISTRAL

lead_sponsor: Hoffmann-La Roche

summary: This single-arm study will assess the efficacy and safety of monthly administration of SC Mircera for the maintenance of hemoglobin levels in participants with chronic kidney disease on peritoneal dialysis. Participants currently receiving maintenance treatment with SC erythropoietin stimulating agents (ESAs) will receive monthly SC injections of Mircera, with the starting dose derived from the last weekly ESA they had been receiving.

location_facility: Hopital Calmette; Medecine General & Nephrologie Serv.

location_facility: Hopital Clemenceau; Nephrologie Hemodialyse

location_facility: HOPITAL NORD; NEPH Transplantation Reanimation

location_facility: Hopital Civil; Nephrologie Clinique Medicale B

location_facility: Ch Pitie Salpetriere; Nephrologie Hemodialyse

location_facility: Hopital Louis Pasteur; Nephrologie - Hemodialyse

location_facility: Polyclin Bordeaux Nord Aquitaine; Nephrologie - Hemodialyse

location_facility: Ch Du Cotentin Site De Cherbourg; Nephrologie

location_facility: Hopital De La Maison Blanche; Nephrologie Hemodialyse

location_facility: CH de Saintonge; Unite 1 Med Interne Nephrologie

location_facility: Hopital Marc Jacquet; Nephrologie Hemodialyse

location_facility: Hopital Manchester; Nephrologie Hemodialyse

location_facility: Hopital de La Source; Service de Nephrologie & Hemodialyse

location_facility: CH Bretagne Atlantique de Vannes; Hemodialyse

location_facility: Unite Autodialyse Paris 14; Dialyse A Domicile

location_facility: Chu La Miletrie;Nephrologie Transplantation

location_facility: Hopital National; Nephrologie Hemodialyse

location_facility: Hôpital Des Brousailles; Service de Néphrologie

location_facility: Ch Georges Renon; Nephrologie Hemodialyse

location_facility: Hopital Bichat Claude Bernard; Nephrologie

title: A Single Arm, Open-Label, Multicentre Study to Assess the Maintenance of Haemoglobin Levels With Once Monthly Subcutaneous Administration of C.E.R.A (Continuous Erythropoietin Receptor Activator) in Patients With Chronic Kidney Disease on Peritoneal Dialysis


title: Randomised, Double-blind, Placebo-controlled Study to Assess Safety and Efficacy of PRI-002 in Patients With MCI to Mild Dementia Due to Alzheimer's Disease (AD) (PRImus-AD)

acronym: PRImus-AD

summary: Alzheimer's disease (AD) is the most common form of dementia. In the brains of people with AD, certain small substances stick together. This leads to changes in thinking and behaviour. The company PRInnovation is developing a new treatment for Alzheimer's disease, called PRI-002. It is thought that PRI-002 can cut the sticked substances back into small pieces. That would reduce the effects of Alzheimer's disease. In the current study the investigators examine whether PRI-002 is safe and effective in participants with mild cognitive impairment (MCI) or mild dementia due to AD.

lead_sponsor: PRInnovation GmbH

collaborators: Federal Agency for Disruptive Innovation - SPRIN-D

location_country: Germany Italy Poland Netherlands Spain Czechia France

location_facility: Clinica Neurologica Dipartimento di Neuroscienze e Imaging (CAST)

location_facility: University Hospital - Pitié-Salpêtrière Hospital/ Charles Foix

location_facility: Revit Sp. z o.o., Podlaskie Centrum Psychogeriatrii

location_facility: Fundació ACE - Institut Català de Neurociències Aplicades

location_facility: Euromedis Sp. z o.o., Centrum Medyczne EUROMEDIS

location_facility: Neuroprotect Sp. z o.o., Centrum Medyczne NeuroProtect

location_facility: Wielospecjalistyczne Centrum Medyczne "Ibismed" s.c.

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS

location_facility: Ospedale Bellaria - IRCCS Istituto delle Scienze Neurologiche

location_facility: Fondazione IRCCS.Istituto Neurologico Carlo Besta

location_facility: ISPG - Institut für Studien zur Psychischen Gesundheit

location_facility: Krakowska Akademia Neurologii Sp. z o.o., Centrum Neurologii Klinicznej

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca


title: IN.PACT™ Quality of Life Post-Reimbursement Study

summary: To prospectively collect and assess the perception of health-related Quality of Life, Pain and Walking Ability.

lead_sponsor: Medtronic

location_facility: Hopitaux Universitaires de Strasbourg - Nouvel Hopital Civil

location_facility: Hopitaux Universitaires Paris lle-France Ouest- Hopital Ambroise- Pare

intervention_type: Combination Product


title: Aged European Population QUality of Life in Infectious Diseases

acronym: AEQUI

summary:
The increasing number of persons >65 years of age form a special population at risk for nosocomial and other health care-associated infections. The vulnerability of this age group is related to impaired host defenses such as diminished cell-mediated immunity. Lifestyle considerations, e.g., travel and living arrangements, and residence in nursing homes, can further complicate the clinical picture. The magnitude and diversity of health care-associated infections in the aging population are generating new arenas for prevention and control efforts.

Common infections leading to hospitalizations in this age group result in respiratory infections and bacteraemia and the impact of these infections on the quality of life and disability in aged populations has not been accurately quantified in a European setting.

This study aims to capture and quantify the impact of infectious diseases on quality of life in an aged population.

design_allocation: Non-Randomized

location_country: Italy Spain France

location_facility: Ospedale Civile di Dolo- ULSS 3 "Serenissima"

location_facility: FIBio-HRYC - Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal

location_facility: Groupement Hospitalier portes de Provence

location_facility: FCRB - Fundació Clínic per a la Recerca Biomèdica

location_facility: Istituto di Geriatria e Gerontologia-Azienda Ospedaliera di Perugia

location_facility: Unità Operativa Complessa di Geriatria-Camposampiero-ULSS 6

location_facility: Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca

location_facility: Unità Operativa Complessa di Geriatria-Legnago-ULSS 9

location_facility: Azienda Ospedaliera Universitaria Policlinico di Palermo

location_facility: Centre Hospitalier Intercommunal de Villeneuve St Georges.

location_facility: FIBio-HCSC - Fundación para la Investigación Biomédica del Hospital Clínico San Carlos

intervention_type: Other


title: Comparison of a Comfort Scale and a Numerical Pain Scale on Opioid Consumption After Surgery: The COMFORT Randomized Trial

acronym: COMFORT

summary:
The objective is to show that the use of therapeutic communication tools, in this case a comfort scale, a low cost and simple to implement method, can reduce pain and therefore the consumption of opioids in the postoperative care unit.

Our hypothesis is that the use of a comfort scale will lead to significant postoperative opioid sparing, and consequently to a decrease in the opioid-related side effects The aim of this study is to compare postoperative opioid consumption between patients whose pain is assessed by a numerical verbal scale and those assessed with a comfort scale.

lead_sponsor: Rennes University Hospital

location_country: Lebanon France

location_facility:
APHP - Hôpital Bichat
CH Bourg en Bresse
CHRU Tours - Hôpital Bretonneau
Polyclinique Saint Laurent de Rennes
Clinique Juge
CHRU Lille - Hôpital Huriez
HIA Clermont Tonnerre
Clinique du Parc
CH La Rochelle
CH Bretagne Atlantique
CH Saint Joseph Saint Luc
CHU Angers
Hôpital Privé Sévigné
Centre Hospitalier Privé St Grégoire
CH Sud Francilien
Clinique Saint-Jean Cap Santé
Chu Rennes - Pontchaillou
CH Dax
CHU Toulouse - Hôpital Rangueil
Hôpital Hôtel Dieu de France
Clinique Jules Verne
CHRU Amiens Picardie
Hôpital Foch
CHU Toulouse - Hôpital Riquet
GHM de Grenoble
CH Pierre Oudot
CH Saint-Brieuc
CHRU Strasbourg - Hôpital Hautepierre
APHP - Hôpital Cochin

intervention_type: Procedure

appel_a_projets: PHRIP

region: Bretagne

nom_etablissement: CHRU RENNES

type_etablissement: CHUR

acronyme: COMFORT

titre: Effet comparé d'une échelle de confort et d'une échelle numérique de douleur sur la consommation d'opiacés en salle de surveillance post-interventionnelle

discipline_principale: anesthésiologie / réanimation

nom_porteur: Meuret

prenom_porteur: Ludovic


title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson's Disease (TEMPO-2 Trial)

summary: The purpose of this study is to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of flexible doses of tavapadon in participants with Parkinson's Disease.

lead_sponsor: Cerevel Therapeutics, LLC

location_country:
Germany
Italy
Poland
Hungary
Australia
United States
Spain
Ukraine
Serbia
France

location_facility: Centrum Medyczne Hope Clinic Sebastian Szklener


title: A Cohort Study of Patients With Metastatic Colorectal Cancer Treated With Avastin® as First-line Therapy for Liver Metastases Considered as Potentially Resectable

acronym: PICASSO

summary: This observational study will evaluate the efficacy and safety of bevacizumab as first-line treatment in participants with colorectal cancer and potentially resectable liver metastases.

location_facility: GH Paris Saint Joseph; Hopital De Jour Oncologie

location_facility: Clinique Du Parc Imperial; Chimiotherapie

location_facility: Memorial France Etats Unis; Hopital De Jour

location_facility: Ch Pitie Salpetriere; Oncologie Medicale

location_facility: Hopital Jacques Lacarin; Hopital De Jour

location_facility: Ghi Le Raincy Montfermeil; Gastro Medecine Interne

location_facility: Ch Lyon Sud; Gastro Secteur Jules Courmont

location_facility: Hopital Charles Nicolle; Endoscopies Digestives

location_facility: Hopital Yves Le Foll; Hepatologie Gastro Enterologie

location_facility: CHU Henri Mondor; Service d'Oncologie Medicale

location_facility: CH Dptal Les Oudairies; Hematologie Oncologie

location_facility: Clinique De L Europe; Radiotherapie Chimiotherapie

location_facility: Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie

location_facility: Ch Jean Rougier; Oncologie Gastro Enterologie

location_facility: Polyclinique de Blois; Chimiotherapie Ambulatoire

location_facility: Hopital De L Archet;Gastro Nutrition Oncologie

location_facility: Ch De Longjumeau; Hopital De Jour Et Semaine

location_facility: Polyclinique Sainte Marguerite; Chimiotherapie

location_facility: Ctre Hosp St Joseph Et St Luc; Gastro Enterologie Endoscopie

location_facility: C.H. Du Pays D'aix En Provence Service du Dr Blanc

location_facility: Chp Saint Gregoire; Cancerologie Radiotherapie

location_facility: Hopital Albert Michallon; Gastro Enterologie

location_facility: CH Du Cotentin Site De Cherbourg; Hopital De Jour

location_facility: Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie

location_facility: Clinique De La Sauvegarde; Chimiotherapie

location_facility: Hopital Clinique Claude Bernard; Oncologie Medicale

location_facility: Hopital De La Croix Rousse;Hepato Gastro Entero

location_facility: CH Dptal Les Oudairies; Gastro Enterologie

location_facility: Polyclinique Du Languedoc; Chimiotherapie

location_facility: Hopital Rene Dubos; Service de Medecine Generale & de Gastro-Enterologie

location_facility: CMCO De La Cote D Opale; Auberge De Jour

location_facility: Clinique Armoricaine Radiologie; Hopital de Jour

location_facility: Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire

location_facility: Hopital Des Diaconesses; Hopital De Jour

location_facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Hopital Alpha Sante De Hayange; Medecine B

location_facility: Infirmerie Protestante; Endos Digestive Coelioscopie

location_facility: HOP Prive Arras Les Bonnettes; Chimiotherapie

location_facility: Ghi Le Raincy Montfermeil; Radiotherapie Oncologie

location_facility: Centre Azureen De Cancerologie; Cons externes

location_facility: Hopital Victor Jousselin; Gastro Enterologie

location_facility: Clinique Des 4 Pavillons; Chimiotherapie

location_facility: Clinique Sainte Marguerite; Oncologie Medicale

location_facility: Centre Hospitalier General; Oncologie Medicale

location_facility: Clinique Pasteur; Oncologie Medicale, Hematologie

location_facility: Fondation Hopital Saint Joseph; Gastro-Enterologie

location_facility: Clinique Champeau Mediterranee; Radiotherapie Oncologie

location_facility: Ch De Montelimar; Gastro Enterologie Oncologie

location_facility: Centre Hospitalier de L'Agglomeration Montargeoise; Medecine Polyvalente A Orientation Mi & Cancero

location_facility: Hopital Du Haut-Leveque; Gastro-Enterologie

location_facility: Clinique Saint Hilaire; Sce Chimiotherapie

location_facility: Clinique Saint Faron; Sce Oncologie Radiotherapie

location_facility: CH Bretagne Sud Site Bodelio; Oncologie Radiotherapie

location_facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie

location_facility: Chu La Miletrie; Gastro Enterologie Endoscopies

location_facility: Clinique Chir De L Orangerie; Chimiotherapie

location_facility: Chi Poissy Saint Germain En Laye; Centre Coordination Cancerologie

location_facility: Hopital Simone Veil Eaubonne; Hopital De Jour

location_facility: Ctre Radiotherapie Joseph Belot; Hematologie

location_facility: Polyclin Bordeaux Nord Aquitaine; Gastro Enterologie


title: A Phase 3, Multicenter, Open-label, Randomized Study of Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Subjects With Surgically Resected Pancreatic Adenocarcinoma

acronym: apact

summary: The purpose of this study is to compare whether there is a delay or prevention of recurrence or death in participants with surgically removed pancreatic cancer who then take nab-Paclitaxel in combination with gemcitabine compared to those who take gemcitabine alone.

ReferenceCitation: Young R, Mainwaring P, Clingan P, Parnis FX, Asghari G, Beale P, Aly A, Botteman M, Romano A, Ferrara S, Margunato-Debay S, Harris M. nab-Paclitaxel plus gemcitabine in metastatic pancreatic adenocarcinoma: Australian subset analyses of the phase III MPACT trial. Asia Pac J Clin Oncol. 2018 Oct;14(5):e325-e331. doi: 10.1111/ajco.12999. Epub 2018 Jun 22.

ReferenceCitation: Reni M, Zanon S, Balzano G, Passoni P, Pircher C, Chiaravalli M, Fugazza C, Ceraulo D, Nicoletti R, Arcidiacono PG, Macchini M, Peretti U, Castoldi R, Doglioni C, Falconi M, Partelli S, Gianni L. A randomised phase 2 trial of nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in locally advanced or borderline resectable pancreatic adenocarcinoma. Eur J Cancer. 2018 Oct;102:95-102. doi: 10.1016/j.ejca.2018.07.007. Epub 2018 Aug 24.

ReferenceCitation: Fernandez A, Salgado M, Garcia A, Buxo E, Vera R, Adeva J, Jimenez-Fonseca P, Quintero G, Llorca C, Canabate M, Lopez LJ, Munoz A, Ramirez P, Gonzalez P, Lopez C, Reboredo M, Gallardo E, Sanchez-Canovas M, Gallego J, Guillen C, Ruiz-Miravet N, Navarro-Perez V, De la Camara J, Ales-Diaz I, Pazo-Cid RA, Carmona-Bayonas A. Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study. BMC Cancer. 2018 Nov 29;18(1):1185. doi: 10.1186/s12885-018-5101-3.

ReferenceCitation: Sonbol MB, Ahn DH, Goldstein D, Okusaka T, Tabernero J, Macarulla T, Reni M, Li CP, O'Neil B, Van Cutsem E, Bekaii-Saab T. CanStem111P trial: a Phase III study of napabucasin plus nab-paclitaxel with gemcitabine. Future Oncol. 2019 Apr;15(12):1295-1302. doi: 10.2217/fon-2018-0903. Epub 2019 Feb 15.

ReferenceCitation: Reni M, Braverman J, Hendifar A, Li CP, Macarulla T, Oh DY, Riess H, Tempero M, Lu B, Marcus J, Joshi N, Botteman M, Dueck AC. Evaluation of Minimal Important Difference and Responder Definition in the EORTC QLQ-PAN26 Module for Assessing Health-Related Quality of Life in Patients with Surgically Resected Pancreatic Adenocarcinoma. Ann Surg Oncol. 2021 Nov;28(12):7545-7554. doi: 10.1245/s10434-021-09816-z. Epub 2021 Apr 3.

oa_host_type: closed

repositories_concat: closed

lead_sponsor: Celgene

location_country:
Finland
Germany
Ireland
Australia
Czechia
Canada
France
Portugal
Hungary
Hong Kong
Denmark
United States
Belgium
Italy
United Kingdom
Singapore
Netherlands
Austria
Korea, Republic of
Spain
Taiwan

location_facility: MSKCC at Mercy Medical Center Mercy RockvilleCenter

location_facility: Hopital Edouard Herriot - Hepato-gastroenterologie

location_facility: Cleveland Clinic - Taussig Cancer Institute

location_facility: Instituto Catalan de Oncologia-Hospital Duran

location_facility: MSKCC at Phelps Memorial Hospital Center. Phelps Sleepy Hollow

location_facility: University of Oklahoma Peggy and Charles Stephenson Cancer Center

location_facility: University of California, San Francisco Cutaneous Oncology and Melanoma Center

location_facility: Praxis Internistischer Onkologie und Hamatologie Frechen

location_facility: Rocky Mountain Cancer Centers, LLP [Denver-Midtown]

location_facility: Klinikum der Johannes Gutenberg Uniervsitaet ,Haematologie

location_facility: Klinikum der Universitat Munchen-Grosshadern

location_facility: University of Rochester Cancer Center, James P. Wilmot Cancer Center

location_facility: Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat

location_facility: Center Hospitalier Universitaire d' Angers

location_facility: Praxis für Innere Medizin, Dr.Oettle Helmut

location_facility: Pole Des Specialites Medicales, Hopital Purpan

location_facility: Ochsner Medical Center - Jefferson Highway

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: University of Wisconsin - Madison Cancer Center

location_facility: Centre Hospitalier de L'Universite de Montreal St-Luc

location_facility: University of Cincinnati Medical CenterDivsion of Hematology OncologyThe Barrett Center

location_facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: Salzburger Landkliniken St. Johanns-Spital

location_facility: State University of New York Upstate Medical Center

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Oregon Health and Science University OHSU

location_facility: Hospital Clinico Universitario De Santiago De Compostela

location_facility: Northshore University Healthsystem Research Institute

location_facility: Praxis Internistischer Onkologie und Hamatologie Koln

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Memorial Sloan-Kettering Cancer Center - NYC

location_facility: University of Miami and Sylvester Cancer Center

location_facility: Karmanos Cancer Center Wayne State University

location_facility: Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center

location_facility: Fovarosi Szent Istvan es Szent Laszlo Korhaz es Rendelointezet

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szent-Gyorgyi Albert TE AOK Borgyogy

location_facility: The Center for Cancer and Blood Disorders - Fort Worth

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

location_facility: Prince of Wales Hospital the Chinese University of Hong Kong

location_facility: Memorial Sloan Kettering Cancer Center West Harrison

location_facility: Chang Gung Medical Foundation-Linkou Branch


title: A Phase IIIb Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

acronym: O'HAND

summary: This study will evaluate the efficacy and safety of ocrelizumab ( Ocrevus®) compared with placebo in participants with primary progressive multiple sclerosis (PPMS), including participants later in their disease course. This study focuses on upper limit disability progression. This study will consist of the following phases: screening, double-blind treatment, follow-up 1 (FU1), an optional open-label extension (OLE), follow-up 2 (FU2), and B-cell monitoring (BCM).

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Germany
Ireland
Poland
New Zealand
Australia
Croatia
Canada
Serbia
France
Colombia
Portugal
Hungary
United States
Morocco
Ukraine
Romania
Tunisia
Lebanon
Belgium
Egypt
Italy
United Kingdom
Austria
Mexico
Spain
Bulgaria
Georgia
Russian Federation

location_facility: Centre Hospitalier de Colmar - Hopital Louis Pasteur; Service de Neurologie

location_facility: M.A. - LEK A. M. Maciejowscy SC. Centrum Terapii SM

location_facility: Complejo Hospitalario Universitario de Vigo

location_facility: Walton Centre For Neurology and Neurosurgery

location_facility: Centre Hospitalier Ibn Sina CHIS - Hopital des Specialites

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Kliniki Neurologii

location_facility: Moscow Regional Research Clinical Institute Na Mfvladimirskiy

location_facility: Dalhousie Multiple Sclerosis Research Unit

location_facility: Complejo Asistencial Universitario de Salamanca ? H. Clinico

location_facility: Separated structural unit ?University clinic? of Dnipro State Medical University

location_facility: Clinica Colsanitas S.A. sede Clinica Universitaria Colombia

location_facility: Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh

location_facility: Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: CHU de Nimes - Hopital Universitaire Caremeau

location_facility: Queen Elizabeth University Hospital - PPDS

location_facility: City Clinical Hospital #15 n.a. N.F. Filatov

location_facility: City Hospital #40 of Kurortniy Administrative District

location_facility: Hopital Militaire d'Instruction Mohamed V

location_facility: New Zealand Clinical Research - Christchurch

location_facility: Zaporizhia City Multispecialty Clinical Hospital #9

location_facility: SBHI of Nizhny Novgorod region City Clinical Hospital #3; neurology department

location_facility: Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: AOU dell Universita degli Studi della Campania Luigi Vanvitelli Piazza Luigi Miraglia 2

location_facility: Medical Clinical Research Center of Medical Center LLC Health Clinic; Department of General Therapy

location_facility: Hospital Universitario HM Sanchinarro-CIOCC

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand

location_facility: Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin

location_facility: Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council

location_facility: Instituto de Investigationes Clinicas para la Salud AC

location_facility: Specjalistyczna Praktyka Lekarska Dr n.med. Stanislaw Ochudlo

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31

location_facility: Raigmore Hospital - PPDS; Highland Clinical Research Facility Center For Health Science

location_facility: LLC Medical Center Family Medicine Clinic

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital

location_facility: Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD

location_facility: Clinical Associates in Research Therapeutics of Americas-Mexico CARTA-MEX

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny

location_facility: Medical Centre of PE First Private Clinic

location_facility: MS and Neuromuscular Center of Excellence

location_facility: Municipal NPE Regional Clinical Center of Neurosurgery and Neurology of Transcarpathian RC

location_facility: Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

location_facility: Centro de Diagnostico Neurofisiologico S.C

location_facility: Multiprofile Hospital For Active Treatment Avis Medica

location_facility: Treatment and Diagnostic Center of LLC MRT Elit

location_facility: The National Hospital for Neurology & Neurosurgery

location_facility: Siberian State Medical University of Roszdrav

location_facility: Nizhegorodskaya Regional Clinical Hospital n.a. Semashko

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Maxine Mesinger MS Clinic/Baylor College of Medicine; Neurology

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku Marii Sklodowskiej Curie 24a

location_facility: Unidad de Investigacion en Salud de Chihuahua

location_facility: Saint George University Medical Hospital

location_facility: American University of Beirut - Medical Center

location_facility: Medical Center of LLC Medical Clinic Blagomed

location_facility: City Out Patient Clinic For Rehabilitation Treatment #7

location_facility: Fondazione Istituto Neurologico Mondino IRCCS

location_facility: Peninsula College of Medicine and Dentistry

location_facility: Centrum Medyczne NeuroProtect Zablocinska 10

location_facility: State Healthcare Institution Territorial Clinical Hospital

location_facility: Targu Mures Clinical Emergency County Hospital

location_facility: Treatment and diagnostic Center Neuro Global of LLC Neuro Global

location_facility: Regional State Budget Institution of Healthcare Tver Regional Clinical Hospital

location_facility: Rejdak Konrad Indywidualna Praktyka Lekarska dr hab. Konrad Rejdak

location_facility: Communal Non-Commercial Enterprise Clinical Hospital #15 of the Podilskyi District ofthe Kyiv City

location_facility: FSBIH Siberian Regional Medical Centre of FMBA of Russia

location_facility: Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: Spitalul Municipal Dr.Alexandru Simionescu Hunedoara


title: Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

summary: This is a Phase 3 trial to evaluate the efficacy and safety of 30 milligrams (mg)/kilogram (kg) intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). There is a 48-week randomized treatment phase followed by an optional, open-label extension phase.

lead_sponsor: FibroGen

location_country:
Germany
Ireland
Poland
Argentina
Brazil
Czechia
Serbia
France
Colombia
Hungary
Denmark
Switzerland
United States
Dominican Republic
Ukraine
Lebanon
China
Peru
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Georgia

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: The Catholic University of Korea Bucheon St. Mary's Hospital

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: National Institute of Phthisiology and Pulmonology named after F. G. Yanovskyi NAMS of Ukraine, Clinical and Functional Department

location_facility: Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel

location_facility: Research Institute Of Clinical Medicine Todua Clinic

location_facility: C.H.R.U. de Montpellier - Hôpital Lapeyronie

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: St. Lucas Clinical Research Center SA de CV

location_facility: Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz

location_facility: Azienda Ospedaliera Citta' della Salute e delle Scienza di Torino

location_facility: Municipal Institute for Lung Diseases and Tuberculosis

location_facility: Papworth Hospital NHS Foundation Trust, Advanced Heart Failure Unit

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: Fundacion Respirar - Centro Médico Dra. De Salvo

location_facility: Instituto Nacional de Enfermedades Respiratorias INER

location_facility: Azienda Ospedaliero-Universitaria "Ospedali Riuniti di Ancona"

location_facility: The General Hospital Corporation d/b/a Massachusetts General Hospital

location_facility: Longarts - Opleider Longziekten Zuyderland MC

location_facility: Ivano-Frankivsk Regional Phthisiology-Pulmonology Center of Ivano-Frankivsk regional council

location_facility: The First Hospital of China Medical University

location_facility: Centre Memoire Ressources Recherche, Hopital F. MITTERRAND

location_facility: TGH/USF Center for Advanced Lung Disease and Lung Transplant

location_facility: Ospedale G.B.Morgagni L.Pierantoni - Azienda Unita Sanitaria Locale (AUSL) di Forli

location_facility: Centro Regional para el estudio del Adulto Mayor, Servicio de Geriatria, Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: INCOR - Instituto do Coração Centro de Pesquisa Prof. Dr. Fulvio Pileggi Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP

location_facility: The Second Affiliated Hospital of Xi'an Jiaotong University

location_facility: Unidad Medica para la Salud Integral (UMSI)

location_facility: Manchester University NHS Foundation Trust

location_facility: Institute for Pulmonary Diseases of Vojvodina

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine

location_facility: Penn State Milton S Hershey Medical Center

location_facility: The Princess Alexandra Hospital NHS Trust

location_facility: Communal non-profit enterprise "City clinical hospital #16" of Dnipro Сit Сouncil

location_facility: Inje University Hospital Iisan Paik Hospital

location_facility: Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust

location_facility: Nemocnice Na Bulovce, Klinika pneumologie

location_facility: Orszagos Koranyi Tbc es Pulmonologiai Intezet, IV. Tudobelosztaly

location_facility: Hospital das Clínicas da UFMG - Centro de Pesquisas Clínicas do Hospital das Clínicas da Universidade Federal de Minas Gerais - CPC HC/UFMG

location_facility: The Catholic University of Korea, Yeouido ST. Mary's Hospital

location_facility: Service de Néphrologie, Hôpital Bretonneau, CHRU de Tours

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Oaxaca Site Management Organization S.C. (OSMO)

location_facility: Pulmonary Disease Specialists d/b/a PDS Research

location_facility: Hospital Nacional Cayetano Heredia / Servicio de Inmunología y Reumatología

location_facility: American University of beirut medical center

location_facility: Seoul National University Bundang Hospital

location_facility: Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: Beijing Frindship hosiptal capital Medical University

location_facility: Hospital Universitario Nuestra Senora de Valme

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos LTDA EPP

location_facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

location_facility: Soonchunhyang University Hospital Bucheon

location_facility: University of Wisconsin Clinical Research

location_facility: Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UPECLIN - UNESP

location_facility: General Hospital of Tianjin Medical University

location_facility: HSL-PUCRS Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul

location_facility: Semmelweis University Clinic of Pulmonology

location_facility: Agaplesion Evangelisches Krankenhaus Mittelhessen

location_facility: BeiJing Chao-Yang Hospital,Capital Medical University

location_facility: Hospital Clinico San Carlos-Madrid C/Martin Lagos s/n

location_facility: Azienda Ospedaliera Universitaria Senese, Policlinico "Le Scotte"

location_facility: Institut fur Pneumologie an der Universitat zu Koln

location_facility: General Hospital of Ningxia Medical University

location_facility: Rafik Hariri University Hospital (Clinical Research Unit)


title: A Post-authorization, Non-interventional, Safety Study Study of Patients With Myelodysplastic Syndromes (MDS) Treated With Lenalidomide.

acronym: PASS MDS del5q

summary:
This registry is a prospective, non-interventional, post authorisation safety study for patients diagnosed with Transfusion Dependent, IPSS low or intermediate-1-Risk Myelodysplastic Syndrome (MDS), associated to a single abnormality of the chromosome 5 [del(5q)].

The purpose of this study is to collect additional data about the safety of an oral drug (lenalidomide, Revlimid®) that may have been prescribed to relieve anemia and decrease the need of blood transfusions. However, also patients affected by the MDS del(5q) who receive other treatments different from lenalidomide can be included in this study, if they agree.

location_country:
Germany
Italy
Norway
United Kingdom
Denmark
Sweden
Belgium
United States
Spain
Luxembourg
Greece
France

location_facility: Hospital Universitario fundacion Jiminez Diaz

location_facility: H.U.Marq.Valdecilla, Hospital Universitario Marqués de Valdecilla. Hematología

location_facility: Lund University Hospital - Lasarettsgatan 23

location_facility: Radcliffe Hospitals and University - Headley Way, Headington

location_facility: Centre Hospitalier D'Avignon - Hopital Henri Duffaut

location_facility: Centre Hospitalier Universitaire De Limoges - Hopital Dupuyt

location_facility: Innere Medizin II - Onkologie, Hämatologie, Univesitatklinikum Tubingen

location_facility: Hospital Universitario central de Asturias

location_facility: Hopital de Hautepierre CHRU de Strasbourg

location_facility: ZENTRUM FÜR INNERE MEDIZIN, Universitatklinikum Wurzburg

location_facility: AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi

location_facility: III. Medizinische Klinik, Hämatologie und internistische Onkologie , Univesitatsmedizin Mannheim

location_facility: Azienda Ospedaliera Papa Giovanni XX111 Piazza OMS

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Aberdeen Royal Infirmary - Foresterhill Road

location_facility: Broomfield Hospital - Mid-Essex Hospitals NHS Trust

location_facility: Policlinico S.Orsola Malpighi, AOU di Bologna

location_facility: Uniklinikum Düsseldorf, Klinik für Hämatologie, Onkologie und Klinische Immunologie

location_facility: Abteilung Hämatologie, Internistische Onkologie, Universitatklinikum Leipzig

location_facility: Hospital del Mar,Hematologia Hemotheropia

location_facility: Azienda Ospedaliera Universitaria di Sassari

location_facility: CHRU De Lille - Hôpital Claude - Rue Michel Polonovski

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Institut für Versorgungsforschung in der Onkologie

location_facility: Hämatologie und Onkologie, Klinikum Chemnitz gGmbH International Patient Center

location_facility: AOU Policlinico Tor Vergata, Università Roma Tor Vergata

location_facility: Praxis, Onkologische Schwerpunktpraxis Dres. Verpoort

location_facility: Gemeinschaftspraxis fur Hamatologie und Onkologie, Onkologisches zentrum Lebach

location_facility: III. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: Kreiskrankenhaus St. Elisabeth - Von Werth-Str.

location_facility: Department of Hematology, Hospital Duran i Reynals

location_facility: CHU Nancy Brabois Adultes - 58 Allee dy morvan

location_facility: Hospital Universitario de Gran Canaria Servicio de Hematología y


intervention_type: Biological

lead_sponsor: MedImmune LLC

summary: The primary goal was to describe the safety of the investigational product when given monthly to prevent serious respiratory infection among children with significant heart disease.

location_facility: Wojewodzki Szpital Dzieciecy W Bydgoszczy

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 im. Tadeusza Sokolowskiego Pomorskiej AM w Szczecinie

location_facility: Instytut "Pomnik - Centrum Zdrowia Dziecka"

location_facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

location_facility: Tulane University Health Sciences Center

location_facility: University Hospitals of Leicester NHS Trust

location_facility: Children's Hospital and Research Center at Oakland

location_facility: Hospital Infantil Universitario Virgen del Rocío

location_facility: University Multifunctional Hospital for Active Treatment

location_facility: Meshalkin Research Institue of Blood circulation

location_facility: Veszprém Megyei Önkormányzat - Csolnoky Ferenc Kórház

location_facility: Schneider Children's Medical Center of Israel

location_facility: Royal Belfast Hospital for Sick Children

location_facility: Children's and Women's Hospital of BC, Room #1R11

location_facility: University of California Davis Medical Center

location_facility: James Whitcomb Riley Hospital for Children

location_facility: Ziekenhuisnetwerk Antwerpen - Koningin Paola Kinderziekenhuis

location_facility: St. Petersburg City Children's Hospital #1

location_facility: American University of Beirut Medical Center

location_facility: Regional Dispensary for Pulmonary Diseases with Inpatient sector-Rousse

location_facility: Universitätsklinik für Kinder- und Jugendheilkunde

location_facility: Multifunctional Hospital for Active Treatment - Pleven

location_facility: Specialized Hospital for Active Treatment of Pediatric Diseases

location_facility: University Mulitiprofile Hospital for Active Treatment "St.Georgi"

location_facility: Washington University School of Medicine

location_facility: Specialized Hospital for Active Treatment of Cardio-vascular Diseases

location_facility: Szegedi Tudomanyegyetem AOK, Gyermekgyogyaszati Klinika

location_facility: Gottsegen Gyorgy Orszagos Kardiologiai Intezet, Gyermeksziv Kozpont

location_facility: Ginekologiczno-Poloznicy Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu

location_facility: Szpital Kliniczny Uniwersytetu Medycznego im. Karola Jonschera

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Saint Petersburg State Pediatric Medical Academy

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Wojewodzki Szpital im. dr Jana Biziela w Bydgoszczy

location_facility: Dzieciecy Szpital Kliniczny im. Prof. Antoniego Gebal Poliklinika

location_facility: Nemours Children's Clinic Biomedical Research Department

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Samodzielny Publiczny Szpital Akademii Medycznej

location_facility: Research Cardiology Institute of Tomsk Scientific Center

location_facility: Suny At Stony Brook University Medical Center

title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Children With Hemodynamically Significant Congenital Heart Disease

primary_purpose: Prevention

location_country:
France
Germany
Poland
Hungary
Israel
Denmark
United Kingdom
Sweden
Austria
Belgium
Lebanon
United States
Spain
Bulgaria
Canada
Russian Federation
Czech Republic


title: Randomized, Open Label, Multicenter, Phase III Study of Entrectinib Versus Crizotinib in Patients With Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring ROS1 Gene Rearrangements With and Without Central Nervous System Metastases

summary: The study will compare the efficacy and safety of entrectinib with crizotinib in participants with advanced or metastatic ROS1 non-small cell lung cancer (NSCLC). The participants will self-administer oral entrectinib or crizotinib as described in the protocol and local prescribing information. Treatments will continue until progressive disease, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Italy
India
Slovakia
Romania
Brazil
Netherlands
Lebanon
Mexico
Sweden
China
Spain
Greece
Croatia
Turkey
Jordan
Russian Federation
France

location_facility: Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: Tata Medical Center; Department of Medical Oncology

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: IRCCS Istituto Regina Elena (IFO); Oncologia Medica B

location_facility: Postgraduate Institute of Medical Education and Research

location_facility: The Second Xiangya Hospital of Central South University

location_facility: Gazi University Medical Faculty, Oncology Hospital

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

location_facility: All India Institute Of Medical Sciences (AIIMS)

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Taihe Hospital of Hubei University of Medicine

location_facility: Karolinska Universitetssjukhuset, Solna; Kliniska prövningsenheten Z:4:01

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga; SSD Oncologia Polomonare (II PAD. IV PIANO)

location_facility: Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

location_facility: Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Guangxi Cancer Hospital of Guangxi Medical University

location_facility: Hospital Universitario; Dr. Jose E. Gonzalez

location_facility: Univerzitna nemocnica Bratislava; Oddelenie Klinickej Onkologie, Klinika Pneumologie A Ftizeologie

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: MVR Cancer Centre and Research Institute

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Emergency County Clinical Hospital Ploiesti; Medical oncology

location_facility: Harbin Medical University Cancer Hospital

location_facility: University Hospital of Larissa;Department of Medical Oncology

location_facility: Mumbai Oncocare Center; Medical Oncology

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

location_facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

location_facility: Affiliated Hospital of Jining Medical University


title: Phase III Randomized Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus Cyclophosphamide, Doxorubicin and Vincristine (CAV) or Topotecan as Treatment in Patients With Small-Cell Lung Cancer (SCLC) Who Failed One Prior Platinum-containing Line (ATLANTIS)

acronym: ATLANTIS

summary: Phase III randomized clinical trial of lurbinectedin (PM01183)/doxorubicin (DOX) versus cyclophosphamide (CTX), doxorubicin (DOX) and vincristine (VCR) (CAV) or topotecan as treatment in patients with small-cell lung cancer (SCLC) who failed one prior platinum-containing line.

ReferenceCitation: Aix SP, Ciuleanu TE, Navarro A, Cousin S, Bonanno L, Smit EF, Chiappori A, Olmedo ME, Horvath I, Grohe C, Farago AF, Lopez-Vilarino JA, Cullell-Young M, Nieto A, Vasco N, Gomez J, Kahatt C, Zeaiter A, Carcereny E, Roubec J, Syrigos K, Lo G, Barneto I, Pope A, Sanchez A, Kattan J, Zarogoulidis K, Waller CF, Bischoff H, Juan-Vidal O, Reinmuth N, Domine M, Paz-Ares L. Combination lurbinectedin and doxorubicin versus physician's choice of chemotherapy in patients with relapsed small-cell lung cancer (ATLANTIS): a multicentre, randomised, open-label, phase 3 trial. Lancet Respir Med. 2023 Jan;11(1):74-86. doi: 10.1016/S2213-2600(22)00309-5. Epub 2022 Oct 14.

publisher_dissemination: Elsevier

lead_sponsor: PharmaMar

location_country:
Germany
Poland
Argentina
Brazil
Czechia
Canada
France
Portugal
Hungary
United States
Romania
Lebanon
Belgium
Italy
United Kingdom
Netherlands
Austria
Spain
Greece
Bulgaria

location_facility: University General Hospital of Heraklion - General Hospital "Venizeleio"

location_facility: SC Centrul de Oncologie Sf. Nectarie SRL, Departament Oncologie Medícala

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Krajska zdravotni a.s. Masarykova nemocnice o.z.

location_facility: Center for Pneumology and Thoracic Surgery

location_facility: Markusovszky Egyetemi Oktatókórház, Pulmonológiai Osztály

location_facility: CORI - Centro Oncológico Riojano Integral

location_facility: Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii Klinicznej, Oddzial Onkologii i Radioterapii

location_facility: Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers

location_facility: Universitätsklinik für Innere Medizin III der PMU

location_facility: Szent Borbála Kórház, Pulmonológiai osztály

location_facility: Instituto COl de Pesquisa, Educação e Gestão

location_facility: IRCCS CROB (Istituto di Ricovero e Cura a Carattere Scientifico)

location_facility: Miskolci Semmelweis Kórház és Egyetemi Oktatókórház, Pulmonológiai Osztály

location_facility: Fejér Megyei Szent György Egyetemi Oktató Kórház, I. Pulmonológiai Osztály

location_facility: The Center for Cancer and Blood Disorders

location_facility: Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital

location_facility: Klinik Löwenstein gGmbH, Med. Klinik II Onkologie

location_facility: Universitätsklinikum Ulm - Klinik für Innere Medizin II, Pneumologie

location_facility: Acibadem City Clinic University Multiprofile Hospital for Active Treatment. EOOD, Sofia; Clinic of Medical Oncology

location_facility: ASST della Valtellina e dell' Alto Lario P.O. Di Sondrio

location_facility: Bristol Cancer Institute, UHB NHS Foundation Trust

location_facility: Corporació Sanitaria Parc Taulí-Hospital de Sabadell

location_facility: Multiprofile Hospital for Active Treatment of Women Health - "Nadezhda", Sofia; Clinic of Medical Oncology

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte

location_facility: Országos Korányi TBC és Pulmonológiai Intézet, 6. Pulmonológia és Bronchologia

location_facility: Katholisches Klinikum Koblenz-Montabaur, Marienhof Koblenz

location_facility: Klinikum Nürnberg Nord - Pneumologische Onkologie

location_facility: Johannes Wesling Klinikum Minden, Klinik für Hämatologie, Onkologie und Palliativmedizin

location_facility: AOU Maggiore della Carità - SC Oncologia

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Institutul Oncologic "Prof. Dr. lon Chiricuta" Cluj-Napoca, Dcpartamentul Oncologie Medicala

location_facility: East Jefferson Hematology-Oncology Metairie Physicians Services, Inc

location_facility: Centro para la Atención Integral del Paciente Oncológico (CAIPO)

location_facility: Boca Raton Regional Hospital Lynn Cancer Institute

location_facility: Centre Hospitalier Universitaire Notre Dame de Secours

location_facility: The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

location_facility: Centre intégré de santé et de services sociaux de la Montérégie Centre

location_facility: lrmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: Hospital General Universitario de Valencia

location_facility: Vivantes Klinikum am Urban, Hämatologie und Onkologie

location_facility: University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski", Sofia

location_facility: Southlake Regional Health Centre - Stronach Regional Cancer Centre

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE

location_facility: Klinikum Bogenhausen, Städt. Klinikum München GmbH, Klinik für Pneumologie und Pneumologische Onkologie

location_facility: Hospital Regional Universitario de Malaga

location_facility: lnstituto de Ensino e Pesquisa Säo Lucas - IEP Säo Lucas

location_facility: Worcestershire Acute Hospitals NHS Trust

location_facility: Städtisches Krankenhaus München Neuperlach

location_facility: University of Munich LMU, Dpt. of Medicine V

location_facility: St Jude Hospital Yorba Linda dba St Joseph Heritage Healthcare

location_facility: Anne Arundel Medical Center Oncology and Hematology

location_facility: American University of Beirut Medical Center

location_facility: Centre Hospitalier Lyon Sud - Service de Pneumologie

location_facility: Joliet Oncology-Hematology Associates, Ltd.

location_facility: Coordenação de Pesquisa Clínica / Instituto Nacional de Câncer

location_facility: Medizinische Universität Wien / AKH Wien, Universitätsklinik für Innere Medizin I, Abteilung für klinische Onkologie

location_facility: Uniklinikum Mannheim, TTZ, Medizinische Fakultät Mannheim

location_facility: Innovative Clinical Research Institute (ICRI)

location_facility: Centro Hospitalar Lisboa Norte, EPE- Hospital Pulido Valente

location_facility: Institutul Oncologic "Prof. Dr. lon Chiricuta" Cluj-Napoca, Sectia Oncologic Medicala

location_facility: Fundação PlO XII - Hospital de Câncer de Barretos

location_facility: General Hospital of Chest Diseases of Athens "Sotiria"

location_facility: Centro Clínico Champalimaud - Fundação Champalimaud

location_facility: Medical Oncology Associates PS (dba Summit Cancer Centers)

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Departament Oncologie Medicala

location_facility: Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. K.Marcinkowskiego w Poznaniu, Oddzial Chemioterapii

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Veszprém Megyei Tüdögyógyintézet, 3. Pulmonológiai Osztály

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center

location_facility: General Hospital of Thessaloniki "G. Papanikolaou", Pulmonary Clinic, Aristotle University of Thessaloniki

location_facility: Spitalul Judetean de Urgenta "Dr. Constantin Opris", Sectia Oncologie Medicala

location_facility: Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele" - Presidio G. Rodolico

location_facility: Vitkovicka nemocnice, a.s., Plicni oddeleni

location_facility: Instituto Médico Especializado Alexander Fleming

location_facility: Associates in Hematology and Oncology, P.C.

location_facility: Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie; Oddzial Onkologii Klinicznej im. dr Ewy Pileckiej z pododdzialem

location_facility: Uniklinik Freiburg, Hämatologie, Onkologie & Stammzellransplantation

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: Hospital Universitari Germans Trias i Pujol ICO

location_facility: Complejo hospitalario regional virgen rocío

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Mazowieckie Centrum Leczenia Chorób Pluc i Gruźlicy Oddzial III Chorób Pluc z Pododdzialem Onkologicznym

location_facility: Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei"

location_facility: Hôpital Nord - Service Oncologie Multidisciplinaire et Innovations Thérapeutiques

location_facility: Centro Hospitalar do Porto, EPE - Hospital de Santo António

location_facility: General Oncology Hospital of Kifissia "Agioi Anargiroi", 2nd Internal Medicine-Oncology Clinic

location_facility: R.S. Mc Laughlin Durham Regional Cancer Centre, Lakeridge Health

location_facility: Hammoud Hospital University Medical Center

location_facility: Centro di Riferimento Oncologico di Aviano

location_facility: Országos Korányi TBC és Pulmonológiai lntézet, 14. Pulmonológia

location_facility: Froedtert Hospital & the Medical College of Wisconsin

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Hospital Universitario Clínico San Carlos

location_facility: MultiCare Institute for Research & Innovation


acronym: Doxo

lead_sponsor: University Hospital Muenster

summary: Analyze pharmacokinetics of doxorubicin in children with cancer. Furthermore investigate the predictive role of troponin and natriuretic peptides for anthracycline-induced cardiotoxicity .

location_facility: MD Nicolas Andre, National Study Manager France

location_facility: Prof. Alan Boddy, National Study Manager UK

location_facility: Prof. Maurizio D'Incalci, National Study Manager Italy

location_facility: Great Ormond Street Hospital for Children

location_facility: Royal Victoria Infirmary, Sir James Spence Institute of Child Health

title: Phase II Pharmacokinetic Study to Assess the Age-dependency in the Clearance of Doxorubicin in Paediatric Patients With Solid Tumours and Leukaemia

location_country:
Germany
Italy
United Kingdom
France