Actively Recruiting

Age: 18Years +
All Genders
NCT03989323

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

Led by Hospices Civils de Lyon · Updated on 2021-07-27

2000

Participants Needed

5

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age > 18
  • Starting anticancer immunotherapy treatment (including immune checkpoint inhibitors like anti-PD-1, anti-PD-L1, anti-CTLA4, anti-Lag-3, anti-Tim-3, anti-TIGIT) alone or with other anticancer drugs
  • Previous immunotherapy must have been more than 6 months ago to be eligible
  • Received written information about IMMUCARE-BASE
  • Patients in clinical trials may be eligible if allowed by the trial's promoter
  • Patients in blinded clinical trials may participate if immunotherapy is not blinded and concomitant participation is allowed
  • Patients who stopped prior IMMUCARE-BASE participation due to treatment change can rejoin if new immunotherapy starts after 6 months from last treatment
  • Signed informed consent for biological sample collection
Not Eligible

You will not qualify if you...

  • Received immunotherapy within 6 months before joining IMMUCARE-BASE
  • Under 18 years old
  • Pregnant women
  • Under legal protection
  • Refused to participate
  • Weight 50 kg or less for biological collection
  • Hemoglobin less than 90 g/L at inclusion
  • Participating in clinical trials with blood samples taken for ancillary studies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Hôpital L. Pradel

Bron, France

Not Yet Recruiting

2

Hôpital Pierre Wertheimer

Bron, France

Not Yet Recruiting

3

Hôpital de la Croix Rousse

Lyon, France

Not Yet Recruiting

4

Hôpital E Herriot

Lyon, France

Not Yet Recruiting

5

Centre Hospitalier LYON SUD

Pierre-Bénite, France

Actively Recruiting

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Research Team

J

Jonathan LOPEZ, MD

CONTACT

S

Sara CALATTINI, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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