Clinical trial NCT05689463: Evaluation of the Prevalence of BP180 and BP230 Autoantibodies in the Serum of Patients With Pruritus Under Immunotherapy
Official title: Evaluation of the Prevalence of BP180 and BP230 Autoantibodies in the Serum of Patients With Pruritus Under Immunotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients With Chronic Pruritus for More Than 1 Month Who Have Received Immunotherapy
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of the study is to evaluate the prevalence of positive anti BP180 and/or anti BP230 serology in the serum of patients with chronic and diffuse pruritus for at least 1 month under immunotherapy and in the absence of obvious pruritic dermatosis (e.g. scabies, contact eczema...).


Eligibility criteria: Inclusion Criteria:

* Patient currently receiving immunotherapy (pembrolizumab, nivolumab, atezolizumab, durvalumab) as monotherapy or in combination OR patient who has received immunotherapy (pembrolizumab, nivolumab, atezolizumab, durvalumab) as monotherapy or in combination within the last 6 months.
* Patients with chronic (\> 1 month) diffuse pruritus, which started after the start of immunotherapy and in the absence of an obvious pruritic dermatosis.
* Woman of childbearing age with effective contraception (see GTFG) (estrogen-progestin or intrauterine device or tubal ligation) for 1 month (negative urine/blood pregnancy test) or Postmenopausal woman: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit)
* Major patient
* Patient having read and understood the information letter and signed the consent form
* Patient affiliated to a social security scheme

Exclusion Criteria:

Pruritus prior to immunotherapy. Bullous pemphigoid prior to immunotherapy End-stage chronic renal failure (GFR \< 15ml/min or dialysis) Clinical jaundice or total bilirubin \> 34 µmol/L Hepatic cholestasis Diabetes mellitus complicated by diabetic neuropathy. History of polycythemia vera History of Hodgkin's lymphoma iron deficiency anemia Current treatment including DPP-4 inhibitors (vildagliptin, linagliptin) Treatment with systemic corticosteroids or immunosuppressant for more than one month.

Pregnant or parturient or breastfeeding woman or absence of proven contraception

· Person deprived of liberty by an administrative or judicial decision or person placed under legal safeguard / sub-tutorship or curatorship

Primary outcomes:
measure: Number of patients on immunotherapy with chronic diffuse pruritus for at least 1 month with positive anti BP180 and/or anti BP230 serology
timeFrame: 1 day
Secondary outcomes:
measure: Number of anti-BP180 and/or anti-BP230 positive patients who will develop urticarial, eczematous or bullous disease
timeFrame: 30 days
measure: Number of anti-BP180 and/or anti-BP230 positive patients who will develop urticarial, eczematous or bullous disease
timeFrame: 1 year
measure: Patient survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Rouen
country: France
facility: UHRouen
Study officials:
affiliation: University Hospital, Rouen
name: Vivien HEBERT, MD
role: PRINCIPAL_INVESTIGATOR
References: