NCT04641884

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2020

Completed
8 months until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

November 24, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

April 9, 2020

Last Update Submit

November 18, 2020

Conditions

Bullous PemphigoidImmunotherapyProgrammed Cell Death Ligand 1

Outcome Measures

Primary Outcomes (5)

  • Clinical situation of the patient features

    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

    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

    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

    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

    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 Outcomes (2)

  • BP treatments

    One day

  • Cancer evolution

    One day

Interventions

Not concernedOTHER

Not concerned

Eligibility Criteria

Age50 Years - 93 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Already descripted.

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant women
  • BP occurring more than 12 months after antiPD-1/PDL-1 therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Nantes, France

RECRUITING

MeSH Terms

Conditions

Pemphigoid, Bullous

Condition Hierarchy (Ancestors)

Skin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Cécile JUZOT

CONTACT

33253482835cecile.ju33@hotmail.fr

Annick COULON

CONTACT

33253482835bp-prom-regl@chu-nantes.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2020

First Posted

November 24, 2020

Study Start

April 1, 2020

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

November 24, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)