- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04641884
Bullous Pemphigoid Induced by antiPD-1/PDL-1 Therapy
Clinical, Biological and Histological Characteristics of Bullous Pemphigoid Induced by antiPD-1/PDL-1 Therapy: A National Retrospective Cohort Study
Immune checkpoint inhibitors (monoclonal antibodies targeting cytotoxic T lymphocyte-associated antigen-4 (CTLA-4), programmed cell death protein 1 (PD-1) or programmed death ligand 1 (PD- L1)) have revolutionized the treatment of many cancers. The widespread use of these treatments has triggered a new spectrum of immune related adverse events (irAE). Several cases of bullous pemphigoid (BP) triggered by antiPD-1/PDL-1 therapy have been reported, and their characteristics are currently poorly described in the literature. The investigators sought to collect the French cases of BP triggered by antiPD-1/PDL-1 therapy, and to describe their clinical, biological and histological characteristics.
In this national, retrospective, observational study, investigators included patients treated with antiPD-1/PDL-1 therapy, with a diagnosis of bullous pemphigoid occurring during treatment or up to 12 months after its discontinuation. Diagnosis of BP was made by the dermatologist and was based on the following criteria: compatible clinical presentation, compatible histopathology findings, positive direct immunofluorescence (DIF) studies, positive enzyme-linked immunosorbent assay BP180/enzyme-linked immunosorbent assay BP230.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Cécile JUZOT
- Phone Number: 33253482835
- Email: cecile.ju33@hotmail.fr
Study Contact Backup
- Name: Annick COULON
- Phone Number: 33253482835
- Email: bp-prom-regl@chu-nantes.fr
Study Locations
-
-
-
Nantes, France
- Recruiting
- University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients treated with PD-1 or PD-L1 inhibitor, with a diagnosis of bullous pemphigoid occurring during treatment or up to 12 months after its discontinuation.
- Diagnosis of the BP based on the following criteria: compatible clinical presentation (absence of atrophic scars, absence of mucosal involvement and absence of predominant bullous lesions on the neck and head), compatible histopathology findings (subepidermal blister on skin biopsy; and linear deposits of IgG and C3 along the basement-membrane zone)
- Positive direct immunofluorescence studies, positive enzyme-linked immunosorbent assay BP180/enzyme-linked immunosorbent assay BP230.
Exclusion Criteria:
- Pregnant women
- BP occurring more than 12 months after antiPD-1/PDL-1 therapy
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical situation of the patient features
Time Frame: One day
|
Composite criteria consisting of the presence of prurit (Yes=0 or No=1).
All the measure will give the rate of 0, the abnormal clinical situation
|
One day
|
Clinical situation of the patient features
Time Frame: One day
|
Composite criteria consisting of the presence of urticarial plaques (Yes=0 or No=1).
All the measure will give the rate of 0, the abnormal clinical situation
|
One day
|
Clinical situation of the patient features
Time Frame: One day
|
Composite criteria consisting of the presence of the number of new blisters per day (less(=1) or more(=0) than 10).
All the measure will give the rate of 0, the abnormal clinical situation.
|
One day
|
Clinical situation of the patient features
Time Frame: One day
|
Composite criteria consisting of eosinophil rate (more than the normal rate = 0 less =1).
All the measure will give the rate of 0, the abnormal clinical situation.
|
One day
|
Clinical situation of the patient features
Time Frame: One day
|
Composite criteria consisting of the enzyme-linked immunosorbent assay for BP180 and BP230 presence =0 absence =1.
All the measure will give the rate of 0, the abnormal clinical situation.
|
One day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BP treatments
Time Frame: One day
|
Rate of corticosteroids, steroids-sparing drugs and other drugs
|
One day
|
Cancer evolution
Time Frame: One day
|
Rate of relapse remission death
|
One day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bullous pemphigoid
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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