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Patient-Reported AutoImmunity Secondary to Cancer immunothErapy

NCT03849131 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 905

Last updated 2025-03-12

No results posted yet for this study

Summary

This is a real life observational longitudinal study aiming to identify autoimmune manifestations in patients treated with "checkpoint inhibitors" in mono or combo therapy in real life.

The study is based on patients reported experience validated by physician, recruited in cancer centers in France with another data collection from a French healthcare data claims database and a biological collection.

Conditions

  • Opportunistic Autoimmune Diseases

Interventions

BIOLOGICAL

Biological collection

Blood samples will be collected only once at enrollment, before initiation of a checkpoint inhibitor. It will include: * DNA samples collection * RNA samples collection * Blood sample collection

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Principal Investigators

  • Jacques-Eric GOTTENBERG, MD, PhD · University Hospital, Strasbourg, France

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-29
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03849131 on ClinicalTrials.gov