[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100408951":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":185,"collaborators":18,"id":187,"slug":188,"hasResults":189,"nctId":190,"briefTitle":191,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":189,"sex":194,"minAge":195,"maxAge":18,"enrollmentInfo":196,"targetDuration":18,"studyType":199,"phases":200,"briefSummary":202,"conditions":203,"keywords":207,"overallStatus":115,"whyStopped":18,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},{"fullName":5,"class":6},"Hospices Civils de Lyon","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tele-monitoring group","EXPERIMENTAL","In the experimental group, in addition to routine practice, each patient will benefit of a tele-monitoring of one year, and a long term follow-up up to 5 years to evaluate the Overall Survival and the Progression-Free Survival. Quality of life questionnaire will also be filled in at inclusion, M3 and M12.\n\n50 patients are expected in this arm.",[13],"Behavioral: Tele-monitoring",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","In the control group, patients will have a routine follow-up as per institutional practice, and a long term follow-up up to 5 years to evaluate the Overall Survival and the Progression-Free Survival. Quality of life questionnaire will also be filled in at inclusion, M3 and M12.\n\n50 patients are expected in this arm.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Tele-monitoring","The tele-monitoring will consist in filling in a specific questionnaire once a week in the first 6 months, every 2 weeks until 12 months, and on-demand (in case of upcoming toxicity, at any time). These questionnaires will be reviewed by a coordinating nurse. According to the result of the questionnaire, the coordinating nurse will adapt patients' management, either by giving them a phone call, or inviting them to directly contact their medical department, or even plan an emergency hospitalization if necessary. The coordinating nurse will closely work with the investigator to adapt patients' management.\n\nQuality of life questionnaire (FACT-G) will also be filled in at inclusion, M3 and M12.",[9],[26],{"name":27,"affiliation":28,"role":29},"Stéphane DALLE","Department of Dermatology, HCL-Cancer Institute","PRINCIPAL_INVESTIGATOR",[31,36],{"name":27,"role":32,"phone":33,"phoneExt":34,"email":35},"CONTACT","0478861679","+33","stephane.dalle@chu-lyon.fr",{"name":37,"role":32,"phone":33,"phoneExt":34,"email":38},"Aurélie RABIER","aurelie.rabier@chu-lyon.fr",[40,58,69,83,93,107,113,145,154,171],{"facility":41,"status":42,"city":43,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Groupement hospitalier Est - Multidisciplinary oncological platform","NOT_YET_RECRUITING","Bron","France","FR",{"type":47,"coordinates":48},"Point",[49,50],4.91303,45.73865,{"lat":50,"lon":49},[53,57],{"name":54,"role":32,"phone":55,"phoneExt":34,"email":56},"Christophe SAJOUS, MD","0427856577","christophe.sajous@chu-lyon.fr",{"name":54,"role":32,"phone":18,"phoneExt":18,"email":18},{"facility":59,"status":42,"city":43,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":60,"geoPoint":62,"contacts":63},"Hôpital Louis Pradel - Department of Pneumology",{"type":47,"coordinates":61},[49,50],{"lat":50,"lon":49},[64,68],{"name":65,"role":32,"phone":66,"phoneExt":34,"email":67},"Michael DURUISSEAUX, MD","0472357644","michael.duruisseaux@chu-lyon.fr",{"name":65,"role":32,"phone":18,"phoneExt":18,"email":18},{"facility":70,"status":42,"city":71,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"University hospital of Grenoble Alpes - Department of dermatology","Grenoble",{"type":47,"coordinates":73},[74,75],5.71479,45.17869,{"lat":75,"lon":74},[78,82],{"name":79,"role":32,"phone":80,"phoneExt":34,"email":81},"Julie CHARLES, MD","0476767575","JCharles@chu-grenoble.fr",{"name":79,"role":32,"phone":18,"phoneExt":18,"email":18},{"facility":84,"status":42,"city":71,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":85,"geoPoint":87,"contacts":88},"University hospital of Grenoble Alpes - Department of Medical Oncology",{"type":47,"coordinates":86},[74,75],{"lat":75,"lon":74},[89,92],{"name":90,"role":32,"phone":18,"phoneExt":18,"email":91},"Mathieu LARAMASSE, MD","mlaramas@chu-grenoble.fr",{"name":90,"role":32,"phone":18,"phoneExt":18,"email":18},{"facility":94,"status":42,"city":95,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Hôpital de la Croix Rousse - Department of Pneumology","Lyon",{"type":47,"coordinates":97},[98,99],4.84789,45.74906,{"lat":99,"lon":98},[102,106],{"name":103,"role":32,"phone":104,"phoneExt":34,"email":105},"Lize KIAKOUAMA-MALEKA, MD","0426109237","lize.kiakouama-maleka@chu-lyon.fr",{"name":103,"role":32,"phone":18,"phoneExt":18,"email":18},{"facility":108,"status":109,"city":95,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":110,"geoPoint":112,"contacts":18},"Hôpital Edouard Herriot - Department of urology","TERMINATED",{"type":47,"coordinates":111},[98,99],{"lat":99,"lon":98},{"facility":114,"status":115,"city":116,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Centre Hospitalier Lyon Sud - Department of Medical Oncology","RECRUITING","Pierre-Bénite",{"type":47,"coordinates":118},[119,120],4.82424,45.70359,{"lat":120,"lon":119},[123,127,128,130,132,134,136,138,140,142,144],{"name":124,"role":32,"phone":125,"phoneExt":34,"email":126},"Denis MAILLET, MD","0478864385","denis.maillet@chu-lyon.fr",{"name":124,"role":32,"phone":18,"phoneExt":18,"email":18},{"name":129,"role":32,"phone":18,"phoneExt":18,"email":18},"Julien PERON, MD",{"name":131,"role":32,"phone":18,"phoneExt":18,"email":18},"Benoit YOU, MD",{"name":133,"role":32,"phone":18,"phoneExt":18,"email":18},"Gilles FREYER, MD",{"name":135,"role":32,"phone":18,"phoneExt":18,"email":18},"Véronique TRILLET-LENOIR, MD",{"name":137,"role":32,"phone":18,"phoneExt":18,"email":18},"Nathalie BONNIN, MD",{"name":139,"role":32,"phone":18,"phoneExt":18,"email":18},"Sophie TARTAS, MD",{"name":141,"role":32,"phone":18,"phoneExt":18,"email":18},"Amandine BRUYAS, MD",{"name":143,"role":32,"phone":18,"phoneExt":18,"email":18},"Sophie DUPLOMB, MD",{"name":54,"role":32,"phone":18,"phoneExt":18,"email":18},{"facility":146,"status":115,"city":116,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":147,"geoPoint":149,"contacts":150},"Hôpital Lyon Sud - Department of Dermatology, HCL-Cancer Institute",{"type":47,"coordinates":148},[119,120],{"lat":120,"lon":119},[151,153],{"name":152,"role":32,"phone":33,"phoneExt":18,"email":35},"Stéphane DALLE, MD",{"name":152,"role":32,"phone":18,"phoneExt":18,"email":18},{"facility":155,"status":115,"city":116,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":156,"geoPoint":158,"contacts":159},"Hôpital Lyon Sud - Department of pneumology,Thoracic oncology",{"type":47,"coordinates":157},[119,120],{"lat":120,"lon":119},[160,164,165,167,169],{"name":161,"role":32,"phone":162,"phoneExt":34,"email":163},"Pierre Jean SOUQUET, MD","0478864401","pierre-jean.souquet@chu-lyon.fr",{"name":161,"role":32,"phone":18,"phoneExt":18,"email":18},{"name":166,"role":32,"phone":18,"phoneExt":18,"email":18},"Sébastien COURAUD, MD",{"name":168,"role":32,"phone":18,"phoneExt":18,"email":18},"Nathalie FREYMOND, MD",{"name":170,"role":32,"phone":18,"phoneExt":18,"email":18},"Clara FONTAINE-DELARUELLE, MD",{"facility":172,"status":42,"city":173,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"University hospital of Saint-Etienne - Department of dermatology","Saint-Etienne",{"type":47,"coordinates":175},[176,177],4.39,45.43389,{"lat":177,"lon":176},[180,184],{"name":181,"role":32,"phone":182,"phoneExt":34,"email":183},"Emmanuelle COUTY, MD","0477828333","j.luc.perrot@chu-st-etienne.fr",{"name":181,"role":32,"phone":18,"phoneExt":18,"email":18},{"type":186,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100408951","impact-of-telemonitoring-for-the-management-of-side-effects-in-patients-with-melanoma-lung-or-renal-cancer-treated-with-immunotherapy-combination-of-nivolumab-and-ipilimumab-or-adjuvant-nivolumab-monotherapy-100408951",false,"NCT04605146","Impact of Telemonitoring for the Management of Side Effects in Patients with Melanoma, Lung or Renal Cancer, Treated with Immunotherapy Combination of Nivolumab and Ipilimumab or Adjuvant Nivolumab Monotherapy","MONITOR","Inclusion Criteria:\n\n* Age \\> 18 years\n* Patients diagnosed with melanoma, or lung cancer or renal cancer\n* Patients starting a treatment with a combination of immunotherapy of nivolumab + ipilimumab (NB: patients who have already received immunotherapy in the past may be included)\n* Patients comfortable with the use of digital tools and computing\n* Patients who agree to participate to the telemonitoring and signed consent form\n\nExclusion Criteria:\n\n* Pregnant, parturient and lactating women\n* Patients under legal protection measure or deprived of their liberty\n* Patients not affiliated to a social security scheme (schemes such as the AME) or beneficiaries of a similar regime (foreign person, outside the EU)","ALL","18 Years",{"count":197,"type":198},100,"ESTIMATED","INTERVENTIONAL",[201],"NA","The ipilimumab and nivolumab combination is now part of the standard of care for the treatment of melanoma, renal and lung cancer patients. Grade 3\u002F4 adverse events (AEs) occur in 30 to 60% of patients included in clinical trials. Grade 3\u002F4 AEs are more frequently observed (50-60% of patients) in melanoma because ipilimumab is administrated at 3mg\u002Fkg in this population. Among these AEs, early detection of immune related AEs is critical to an adequate medical management. In this context, dedicated tools for remote monitoring of these patients are crucial.\n\nThe investigators developed within the Immucare consortium a simplified medical questionnaire which is addressed weekly to the patients. This questionnaire along with an algorithm gives to the clinician regular feedback on their patients' general symptoms. The investigators herein want to evaluate in a randomized prospective trial the efficacy of this remote monitoring to reduce the time between the start of AE and the reporting to the medical team, which could lead to detect and treat earlier AEs induced by nivolumab and ipilimumab in the melanoma, lung and renal cancer patients' population.",[204,205,206],"Melanoma","Lung Cancer","Renal Cancer",[22,208,209,210],"nivolumab","ipilimumab","immunotherapy","2024-10-14",{"date":213,"type":214},"2024-10-16","ACTUAL",{"date":216,"type":214},"2021-05-05",{"date":218,"type":198},"2028-11-05",{"name":5,"class":6},10]