- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03140137
Immune Checkpoint Inhibitors and Pre-existing Autoimmune Diseases
April 19, 2019 updated by: University Hospital, Brest
Retrospective Observational Study on the Safety of Immune Checkpoint Inhibitors in the Treatment of Advanced Melanoma and Lung Cancers in Patients With Pre-Existing Autoimmune Diseases
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
112
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
AIX en PROVENCE, France, 13616
- CH d'AIX
-
Dijon, France, 21079
- CHU de Dijon
-
La Roche-sur-Yon, France, 85925
- CHD Vendée
-
Le Mans, France, 72000
- CH Le Mans
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Macon, France, 78018
- CH de Macon
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with a pre-existing autoimmune disease who received immune checkpoint inhibitors for the treatment of an advanced cancer in clinical practice.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Autoimmune disease flare
Time Frame: through study completion, an average of 1 year
|
Increase in the activity of the pre-existing autoimmune disease as assessed by the treating physician
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Other immune/inflammatory complications
Time Frame: through study completion, an average of 1 year
|
Development of a new immune/inflammatory condition after the start of the therapy
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Divi Cornec, CHRU de Brest
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 21, 2017
Primary Completion (ACTUAL)
January 4, 2018
Study Completion (ACTUAL)
January 4, 2018
Study Registration Dates
First Submitted
February 24, 2017
First Submitted That Met QC Criteria
May 2, 2017
First Posted (ACTUAL)
May 4, 2017
Study Record Updates
Last Update Posted (ACTUAL)
April 22, 2019
Last Update Submitted That Met QC Criteria
April 19, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHECKAUTO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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