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ETCABio - Evaluation of Skin Tests in Biotherapy Allergies
EU CTIS ID: 2024-519812-15-00
What this study is testing
The primary objective is to determine, in non-allergic patients treated with biotherapy, the maximum non-irritant concentration of the biotherapy that can be used in allergologic skin tests (prick tests and intradermal tests) for patients suspected of hypersensitivity to the said biotherapy.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Patient treated with one of the biotherapies under study (Atezolizumab, Nivolumab, Obinutuzumab, Durvalumab, Pembrolizumab, Daratumumab, Cemiplimab) and who has received at least two injections of the biotherapy without suspected allergic side effects.
- Subjects covered by or having the rights to medical care assurance
- Written informed consent obtained from subject
- If applicable, treatment with corticosteroids and H1 antihistamines by systemic route (IV or oral) which may be discontinued at least one week before performing the tests (Inhaled corticosteroids are allowed).
You likely can't join if
- Presence of local or diffuse dermatological lesions (e.g., psoriasis, eczema, ...) that could interfere with the interpretation of skin tests.
- Poor understanding of the French language.
- Pregnancy, breastfeeding* (For women of childbearing age, the absence of pregnancy will be confirmed by a blood pregnancy test (unless already conducted as part of the care or if pregnancy is ruled out).
- Persons in detention by judicial or administrative decision
- Person admitted to a health or social establishment for purposes other than research
- Person subject to a legal protection measure
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.