NCT03989323 A Clinical and Biological Prospective Database of Patients Treated With Anticancer Immunotherapy and Follow up of Their Immune-related Adverse Events irAE
| NCT ID | NCT03989323 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2019-07-15 |
| Primary Completion | 2029-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2019-07-15 with a primary completion date of 2029-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The number of patients affected by cancer and treated with immunotherapy is continuously increasing. With the advent of these new therapies, the investigators observe the emergence of new and unexpected toxicities. The care of patients treated with these molecules require the development of multidisciplinary skills and the introduction of a professional network capable of taking care of immunotherapy related toxicity (irAE) that can affect different organs and for which immediate and effective interventions are necessary for patient survival. IMMUCARE-BASE will comprehensively enable the collection, of clinical and biological data of patients treated with anticancer immunotherapy. The creation of this database is essential to identify clinico-biological factors predisposing to toxicity, and to define the best strategies to prevent the early onset of irAE and/or to treat them. Ultimately, the objective of this database is to collect enough data to be able to personalise in the future the immunotherapy treatment according to the benefits and to anticipate risks for each patient. The objective of the biological collection is to perform ancillary studies for understanding mechanism leading to toxicity and for the development of research programs in the field of immunotherapy.
Eligibility 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.
Contact & Investigator
Jonathan LOPEZ, MD
STUDY DIRECTOR
Hospices Civils de Lyon
Frequently Asked Questions
Who can join the NCT03989323 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03989323 currently recruiting?
Yes, NCT03989323 is actively recruiting participants. Contact the research team at jonathan.lopez@chu-lyon.fr for enrollment information.
Where is the NCT03989323 trial being conducted?
This trial is being conducted at Bron, France, Bron, France, Lyon, France, Lyon, France and 1 additional location.
Who is sponsoring the NCT03989323 clinical trial?
NCT03989323 is sponsored by Hospices Civils de Lyon. The principal investigator is Jonathan LOPEZ, MD at Hospices Civils de Lyon. The trial plans to enroll 2,000 participants.
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