Database for patients treated with cancer immunotherapy and their side effects
A Clinical and Biological Prospective Database of Patients Treated With Anticancer Immunotherapy and Follow up of Their Immune-related Adverse Events irAE
Hospices Civils de Lyon · NCT03989323
This study is trying to gather information about side effects from cancer immunotherapy to help doctors understand and manage these issues better for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon (other) |
| Drugs / interventions | immunotherapy |
| Locations | 5 sites (Bron and 4 other locations) |
| Trial ID | NCT03989323 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a comprehensive database of clinical and biological data from patients undergoing anticancer immunotherapy. It focuses on identifying immune-related adverse events (irAEs) that can arise from these treatments, which may affect various organs and require immediate intervention. By collecting this data, the study seeks to understand the factors that predispose patients to these toxicities and to develop strategies for their prevention and management. The ultimate goal is to personalize treatment approaches for better patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 who are starting or have recently received anticancer immunotherapy.
Not a fit: Patients who are not starting immunotherapy or have received it within the last six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and prevention of side effects associated with cancer immunotherapy, enhancing patient safety and treatment efficacy.
How similar studies have performed: Other studies have shown success in collecting data on immunotherapy-related toxicities, indicating that this approach is both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 * Patient starting anticancer immunotherapy treatment(immune checkpoint inhibitors like anti-PD-1, anti-PD-L1, anti-CTLA4, anti-Lag-3, anti-Tim-3, anti-TIGIT or other new anticancer immunotherapy) in monotherapy or associatied with other anticancer molecules. * Patient who had already received immunotherapy can be eligible to IMMUCARE-BASE provided that the last immunotherapy treatment had been administered \> 6 months ago. * Patient who received written information about IMMUCARE-BASE. * Patient receiving immunotherapy as a part of a clinical trial can be eligible to IMMUCARE-BASE according to the indications given by the promoter of this trial. * Patient in a clinical trial which includes a combination of therapy with one of the drugs administered in a blind manner vs placebo, can be eligible to IMMUCARE-BASE provided that (i) the treatment administered in a blind manner is not the immunotherapy and (ii) the clinical trial allows concomitant participation of a patient in another non-interventional study. * A Patient that has been already included in IMMUCARE-BASE and who terminates the study because of a change of treatment, can be included again in IMMUCARE-BASE if he/she agrees and provided that (i) is the new treatment includes immunotherapy (alone or in association with other anticancer molecules) and (iii) the new immunotherapy treatment is administered after 6 months from the last administration of the previous immunotherapy. Inclusion criteria specific to the biological collection: -Signature of the informed consent. Exclusion Criteria: * Patient who had received immunotherapy within 6 months before entering in IMMUCARE-BASE * Minor patient * Pregnant women * Patient under juridical protection * Patient refusal to participate. Exclusion criteria for the biological collection: * Weight ≤ 50kg * Haemoglobin \< 90g/L at the time of the inclusion * Patient participating in clinical trials where blood samples are taken for ancillary studies.
Where this trial is running
Bron and 4 other locations
- Hôpital L. Pradel — Bron, France (NOT_YET_RECRUITING)
- Hôpital Pierre Wertheimer — Bron, France (NOT_YET_RECRUITING)
- Hôpital de la Croix Rousse — Lyon, France (NOT_YET_RECRUITING)
- Hôpital E Herriot — Lyon, France (NOT_YET_RECRUITING)
- Centre Hospitalier LYON SUD — Pierre-Bénite, France (RECRUITING)
Study contacts
- Study coordinator: Jonathan LOPEZ, MD
- Email: jonathan.lopez@chu-lyon.fr
- Phone: +33 4 78 86 16 07
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer