A Clinical and Biological Prospective Database of Patients Treated With Anticancer Immunotherapy and Follow up of Their Immune-related Adverse Events irAE (IMMUCARE-BASE)

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: Estimation of the incidence of the irAE

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Jonathan LOPEZ, MD; Phone Number: +33 +33 4 78 86 16 07; Email: jonathan.lopez@chu-lyon.fr
• Study Contact Backup: Name: Sara CALATTINI, PhD; Phone Number: +33 +33 4.78.86.37.79; Email: sara.calattini@chu-lyon.fr

Study Locations

• France
  • Bron, France
    • Not yet recruiting
    • Hôpital L. Pradel
    • Contact: Sara Calattini, PhD
    • Sub-Investigator: Michael DURUISSEAUX, MD
    • Sub-Investigator: Gerald RAVEROT, MD
    • Sub-Investigator: Juliette ABEILLON, MD
  • Bron, France
    • Not yet recruiting
    • Hôpital Pierre Wertheimer
    • Contact: Sara Calattini, PhD
    • Sub-Investigator: Jerome HONNORAT, MD
    • Sub-Investigator: Bastien JOUBERT, MD
  • Lyon, France
    • Not yet recruiting
    • Hôpital de la Croix Rousse
    • Sub-Investigator: Philippe MERLE, MD
    • Contact: Sara Calattini, PhD
    • Sub-Investigator: Lize KIAKOUAMA-MALEKA, MD
    • Sub-Investigator: Fanny LEBOSSE, MD
    • Sub-Investigator: Fabien ZOULIM, MD
  • Lyon, France
    • Not yet recruiting
    • Hôpital E Herriot
    • Sub-Investigator: Catherine LOMBARD-BOHAS, MD
    • Contact: Sara Calattini, PhD
  • Pierre-Bénite, France
    • Recruiting
    • Centre Hospitalier Lyon Sud
    • Sub-Investigator: Olivia LE SAUX, MD
    • Sub-Investigator: Salima HAMIZI, MD
    • Sub-Investigator: Stéphane DALLE, MD
    • Contact: Jonathan LOPEZ, MD; Phone Number: +33 +33 4 78 86 16 07; Email: jonathan.lopez@chu-lyon.fr
    • Contact: Sara CALATTINI, PhD; Phone Number: +33 +33 4.78.86.37.79; Email: sara.calattini@chu-lyon.fr
    • Sub-Investigator: Luc THOMAS, MD
    • Sub-Investigator: Mona AMINI-ADL, MD
    • Sub-Investigator: Nicolas Poulalhon, MD
    • Sub-Investigator: Marie Perier-Muzet, MD
    • Sub-Investigator: Pierre Jean SOUQUET, MD
    • Sub-Investigator: Clara DELARUELLE, MD
    • Sub-Investigator: Marion CHAUVENET, MD
    • Sub-Investigator: Stéphane NANCEY, MD
    • Sub-Investigator: Claire FALANDRY, MD
    • Sub-Investigator: Cyril CONFAVREUX, MD
    • Sub-Investigator: Emmanuel BACHY, MD
    • Sub-Investigator: Gilles SALLES, MD
    • Sub-Investigator: Lionel KARLIN, MD
    • Sub-Investigator: Christine CUGNET-ANCEAU, MD
    • Sub-Investigator: Charles THIVOLET, MD
    • Sub-Investigator: Julien VOUILLARMET, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients treated with immunotherapy; Patients receiving for the first time an immunotherapy treatment for their cancer (Checkpoints inhibitors, such as PD-1 or PD-L1 or CTLA4…). Patients will be enrolled before starting the immunotherapy treatment and will be followed up for 5 years or until the permanent discontinuation of the immunotherapy treatment to describe the arm.	Other: Estimation of the incidence of the irAE; Assessment of the incidence of the irAE in patients treated with immunotherapy at the Hospices Civils de Lyon (irAE of all grades and from all organs) and creation of a biological collection of blood, plasma, serum and PBMCs from patients before treatment, under treatment and at the onset of irAEs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Patients can be treated with immunotherapy alone, or in association with other immunotherapies, or association with chemotherapies, targeted therapies or radiotherapy. It will include all types of cancers that can be treated with immunotherapy, also including patients that are in clinical trials.	10 years

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Study Director: Jonathan LOPEZ, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 15, 2019
• Primary Completion (ANTICIPATED): July 15, 2029
• Study Completion (ANTICIPATED): July 15, 2029

Study Registration Dates

• First Submitted: June 14, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (ACTUAL): June 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 69HCL18_0816

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No