Bullous PemphigoidNCT04641884
Bullous Pemphigoid Induced by antiPD-1/PDL-1 Therapy
An observational study of Bullous Pemphigoid and Immunotherapy, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 93 years
- Conditions the study is for
- Bullous Pemphigoid, Immunotherapy, Programmed Cell Death Ligand 1
- What is being tested?
- Not concerned
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 93 years
- All sexes
- Adult, Older adult
Study population: Already descripted.
Who may be able to join
- 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.
Who cannot join
- Pregnant women
- BP occurring more than 12 months after antiPD-1/PDL-1 therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
All members of French study Group on Autoimmune Bullous Skin Diseases and French group of Onco-dermatology were asked to report cases of bullous pemphigoid induced by antiPD-1/PDL-1 therapy from 2014 to 2019. In this retrospective, observational cohort study, investigators included 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 BP was made by the dermatologist and was based on the following criteria developed by the French Bullous Study Group : 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 DIF studies, positive enzyme-linked immunosorbent assay BP180/enzyme-linked immunosorbent assay BP230. For each case, collected data were : sex, type of tumor, type of checkpoint inhibitor, age at the onset of the checkpoint inhibitor, time from the onset of BP compared to the onset of the PD-1 inhibitor, clinical presentation of BP, results of complementary exams (skin biopsies, enzyme-linked immunosorbent assay for BP180 and BP230 and indirect immunofluorescence studies if available); treatment of BP used, consequence on antiPD-1/PD-L1 therapy, course of the tumor, other irAEs. Overall tumor response was determined by the treating oncologist and classified using RECIST 1.1 (Response Evaluation Criteria in Solid Tumors).
- Being tested
- Not concerned
- Medical subject headings
- Pemphigoid, Bullous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not concernedOther
Not concerned
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One day
Secondary outcomes (2)
BP treatments
Rate of corticosteroids, steroids-sparing drugs and other drugs
Measured: One day
Cancer evolution
Rate of relapse remission death
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start1 Apr 2020
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullous PemphigoidStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641884
- Sponsor's protocol ID
- Bullous pemphigoid
- Status last verified
- Oct 2020
- First submitted
- 9 Apr 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Biological and Histological Characteristics of Bullous Pemphigoid Induced by antiPD-1/PDL-1 Therapy: A National Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04641884
- Acronym / sponsor ID
- Bullous pemphigoid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 24 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All members of French study Group on Autoimmune Bullous Skin Diseases and French group of Onco-dermatology were asked to report cases of bullous pemphigoid induced by antiPD-1/PDL-1 therapy from 2014 to 2019. In this retrospective, observational cohort study, investigators included 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 BP was made by the dermatologist and was based on the following criteria developed by the French Bullous Study Group : 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 DIF studies, positive enzyme-linked immunosorbent assay BP180/enzyme-linked immunosorbent assay BP230. For each case, collected data were : sex, type of tumor, type of checkpoint inhibitor, age at the onset of the checkpoint inhibitor, time from the onset of BP compared to the onset of the PD-1 inhibitor, clinical presentation of BP, results of complementary exams (skin biopsies, enzyme-linked immunosorbent assay for BP180 and BP230 and indirect immunofluorescence studies if available); treatment of BP used, consequence on antiPD-1/PD-L1 therapy, course of the tumor, other irAEs. Overall tumor response was determined by the treating oncologist and classified using RECIST 1.1 (Response Evaluation Criteria in Solid Tumors).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 to 93 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Already descripted.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnant women
- BP occurring more than 12 months after antiPD-1/PDL-1 therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not concernedNot concerned | Other | – |
Primary outcome
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
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
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.
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.
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.
2 secondary outcomes
BP treatments
Time frame: One day
Cancer evolution
Time frame: One day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bullous Pemphigoid and Immunotherapy, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cécile JUZOT (33253482835, cecile.ju33@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical situation of the patient features (time frame: One day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.