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Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

Official Title: 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

Study ID: NCT04605146

Interventions

Tele-monitoring

Study Description

Brief Summary: The ipilimumab and nivolumab combination is now part of the standard of care for the treatment of melanoma, renal and lung cancer patients. Grade 3/4 adverse events (AEs) occur in 30 to 60% of patients included in clinical trials. Grade 3/4 AEs are more frequently observed (50-60% of patients) in melanoma because ipilimumab is administrated at 3mg/kg 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. The 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Groupement hospitalier Est - Multidisciplinary oncological platform, Bron, , France

Hôpital Louis Pradel - Department of Pneumology, Bron, , France

University hospital of Grenoble Alpes - Department of dermatology, Grenoble, , France

University hospital of Grenoble Alpes - Department of Medical Oncology, Grenoble, , France

Hôpital de la Croix Rousse - Department of Pneumology, Lyon, , France

Hôpital Edouard Herriot - Department of urology, Lyon, , France

Centre Hospitalier Lyon Sud - Department of Medical Oncology, Pierre-Bénite, , France

Hôpital Lyon Sud - Department of Dermatology, HCL-Cancer Institute, Pierre-Bénite, , France

Hôpital Lyon Sud - Department of pneumology,Thoracic oncology, Pierre-Bénite, , France

University hospital of Saint-Etienne - Department of dermatology, Saint-Étienne, , France

Contact Details

Name: Stéphane DALLE

Affiliation: Department of Dermatology, HCL-Cancer Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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