Clinical trial NCT03989323: A Clinical and Biological Prospective Database of Patients Treated With Anticancer Immunotherapy and Follow up of Their Immune-related Adverse Events irAE
Official title: A Clinical and Biological Prospective Database of Patients Treated With Anticancer Immunotherapy and Follow up of Their Immune-related Adverse Events irAE
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with cancer and starting anticancer immunotherapy (-immune checkpoint inhibitors: anti-PD-1, anti-PD-L1, anti-CTLA4, anti-Lag-3, anti-Tim-3, anti-TIGIT or other new emerging immune checkpoint inhibitors).

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.

Primary outcomes:
measure: Estimation of the incidence of immunotherapy-related toxicities (all grades, of all organs, in real life) in patients treated for the first time with anticancer immunotherapy and enrolled in the "IMMUCARE-BASE" clinical database
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital L. Pradel
city: Bron
country: France
facility: Hôpital Pierre Wertheimer
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Lyon
country: France
facility: Hôpital E Herriot
city: Pierre-Bénite
country: France
facility: Centre Hospitalier LYON SUD
Study officials:
affiliation: Hospices Civils de Lyon
name: Jonathan LOPEZ, MD
role: STUDY_DIRECTOR
References: