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ETCABio - Evaluation of Skin Tests in Biotherapy Allergies

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519812-15-00
Enrollment
140
Registered
2025-04-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AL amyloidosis, Cholangiocarcinoma, Chronic lymphocytic leukemia (CLL), deficient mismatch repair (dMMR) colorectal adenocarcinoma, deficient mismatch repair (dMMR) colorectal cancer, Esophageal squamous cell carcinoma, Follicular lymphoma, Gastric cardia cancer, Hepatocellular carcinoma, Hodgkin lymphoma, Locally advanced cutaneous squamous cell carcinoma, Melanoma, Myeloma, Non-small cell lung carcinoma, Pleural mesothelioma, Small cell lung carcinoma

Brief summary

For each biotherapy studied, the maximum usable concentration considered non-irritant is defined as the maximum concentration that does not produce a skin reaction in at least 9 out of 10 patients (90% specificity) during skin testing.

Detailed description

A delayed reaction is considered if, at the intradermal injection sites, a skin reaction occurs 48 hours or one week after injection, or if a systemic reaction occurs following biotherapy administration. Patients will be contacted by phone to confirm the presence or absence of a delayed local reaction, and if necessary, a photograph taken during a consultation with the allergologist investigator or in a video consultation will confirm the reaction.

Interventions

DRUGATEZOLIZUMAB
DRUGDARATUMUMAB
DRUGNIVOLUMAB
DRUGDURVALUMAB
DRUGCEMIPLIMAB
DRUGOBINUTUZUMAB
DRUGPEMBROLIZUMAB

Sponsors

Centre Hospitalier Universitaire D'Angers
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
For each biotherapy studied, the maximum usable concentration considered non-irritant is defined as the maximum concentration that does not produce a skin reaction in at least 9 out of 10 patients (90% specificity) during skin testing.

Secondary

MeasureTime frame
A delayed reaction is considered if, at the intradermal injection sites, a skin reaction occurs 48 hours or one week after injection, or if a systemic reaction occurs following biotherapy administration. Patients will be contacted by phone to confirm the presence or absence of a delayed local reaction, and if necessary, a photograph taken during a consultation with the allergologist investigator or in a video consultation will confirm the reaction.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026