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

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ClinicalTrials.gov Identifier: NCT03989323
Recruitment Status : Not yet recruiting
First Posted : June 18, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment
Cancer Other: Estimation of the incidence of the irAE

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Clinical and Biological Prospective Database of Patients Treated With Anticancer Immunotherapy and Follow up of Their Immune-related Adverse Events irAE
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : June 2029
Estimated Study Completion Date : June 2029

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.




Primary Outcome Measures :
  1. 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 [ Time Frame: 10 years ]
    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.


Biospecimen Retention:   Samples With DNA
Peripheral blood samples (36 mL) will be collected at the time of the first and second immunotherapy administrations, during routine care. In the case of grade 3 or 4 toxicities, blood samples will be collected as well at the time of irAE onset.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03989323


Contacts
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Contact: Jonathan LOPEZ, MD +33 4 78 86 16 07 ext +33 jonathan.lopez@chu-lyon.fr
Contact: Sara CALATTINI, PhD +33 4.78.86.37.79 ext +33 sara.calattini@chu-lyon.fr

Locations
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France
Hôpital L. Pradel Not yet recruiting
Bron, France
Contact: Sara Calattini, PhD         
Sub-Investigator: Michael DURUISSEAUX, MD         
Sub-Investigator: Gerald RAVEROT, MD         
Sub-Investigator: Juliette ABEILLON, MD         
Hôpital Pierre Wertheimer Not yet recruiting
Bron, France
Contact: Sara Calattini, PhD         
Sub-Investigator: Jerome HONNORAT, MD         
Sub-Investigator: Bastien JOUBERT, MD         
Hôpital de la Croix Rousse Not yet recruiting
Lyon, France
Contact: Sara Calattini, PhD         
Sub-Investigator: Lize KIAKOUAMA-MALEKA, MD         
Sub-Investigator: Philippe CERUSE, MD         
Sub-Investigator: Amandine BRUYAS, MD         
Sub-Investigator: Fanny LEBOSSE, MD         
Sub-Investigator: Philippe MERLE, MD         
Sub-Investigator: Francois BAILLY, MD         
Sub-Investigator: Fabien ZOULIM, MD         
Hôpital E Herriot Not yet recruiting
Lyon, France
Contact: Sara Calattini, PhD         
Sub-Investigator: Thomas WALTER, MD         
Sub-Investigator: Catherine LOMBARD-BOHAS, MD         
Centre Hospitalier LYON SUD Not yet recruiting
Pierre-Bénite, France
Contact: Jonathan LOPEZ, MD    +33 4 78 86 16 07 ext +33    jonathan.lopez@chu-lyon.fr   
Contact: Sara CALATTINI, PhD    +33 4.78.86.37.79 ext +33    sara.calattini@chu-lyon.fr   
Sub-Investigator: Stéphane DALLE, MD         
Sub-Investigator: Luc THOMAS, MD         
Sub-Investigator: Mona AMINI-ADL, MD         
Sub-Investigator: Sébastien DEBARBIEUX, MD         
Sub-Investigator: Nicolas POULALHON, MD         
Sub-Investigator: Marie PERIER-MUZET, MD         
Sub-Investigator: Pierre Jean SOUQUET, MD         
Sub-Investigator: Sébastien COURAUD, MD         
Sub-Investigator: Nathalie FREYMOND, MD         
Sub-Investigator: Clara DELARUELLE, MD         
Sub-Investigator: Gilles BOSCHETTI, MD         
Sub-Investigator: Marion CHAUVENET, MD         
Sub-Investigator: Stéphane NANCEY, MD         
Sub-Investigator: Denis MAILLET, MD         
Sub-Investigator: Julien PERON, MD         
Sub-Investigator: Benoit YOU, MD         
Sub-Investigator: Gilles FREYER, MD         
Sub-Investigator: Véronique TRILLET-LENOIR, MD         
Sub-Investigator: Nathalie BONNIN, MD         
Sub-Investigator: Sophie TARTAS, MD         
Sub-Investigator: Salima HAMIZI, MD         
Sub-Investigator: Amandine BRUYAS, MD         
Sub-Investigator: Olivia LE SAUX, MD         
Sub-Investigator: Sophie DUPLOMB, MD         
Sub-Investigator: Christophe SAJOUS, 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: Hervé GHESQUIERES, MD         
Sub-Investigator: Christine CUGNET-ANCEAU, MD         
Sub-Investigator: Charles THIVOLET, MD         
Sub-Investigator: Julien VOUILLARMET, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Study Director: Jonathan LOPEZ, MD Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03989323     History of Changes
Other Study ID Numbers: 69HCL18_0816
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Immunologic Factors
Physiological Effects of Drugs