Immune Checkpoint Inhibitors and Pre-existing Autoimmune Diseases

NCT ID: NCT03140137

Last Updated: 2019-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-21

Study Completion Date

2018-01-04

Brief Summary

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The tolerance of immune checkpoint inhibitors is unknown in patients with pre-existing autoimmune conditions. This retrospective nation-wide study will assess their tolerance in patients with pre-existing autoimmune conditions who received immune checkpoint inhibitors for an advanced cancer in clinical practice.

Detailed Description

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Conditions

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Autoimmune Diseases Advanced Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Checkpoint inhibitor therapy

Treatment by ipilimumab, nivolumab or pembrolizumab for advanced cancer in clinical practice

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pre-existing autoimmune disease as diagnosed by the physician
* Immune checkpoint inhibitor therapy for an advanced cancer

Exclusion Criteria

* Auto-immune disease developed only after the start of the immune checkpoint inhibitor therapy
* Absence of follow-up
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Divi CORNEC

Role: STUDY_DIRECTOR

CHRU de Brest

Locations

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CH d'AIX

Aix-en-Provence, , France

Site Status

CHU de DIJON

Dijon, , France

Site Status

CHD Vendée

La Roche-sur-Yon, , France

Site Status

Ch Le Mans

Le Mans, , France

Site Status

CH de MACON

Mâcon, , France

Site Status

Countries

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France

Other Identifiers

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CHECKAUTO

Identifier Type: -

Identifier Source: org_study_id

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