Evaluating patient tolerance and information after biopsies for autoimmune diseases
SAfety and TOlerance of the Biopsies in Auto-immune Rare dIseases
University Hospital, Brest · NCT05022420
This study is trying to see how well patients handle biopsies for autoimmune diseases and if they feel they got enough information about the procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Brest (other) |
| Locations | 8 sites (Angers and 7 other locations) |
| Trial ID | NCT05022420 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the tolerance and information provided to patients undergoing biopsies for autoimmune diseases, specifically focusing on salivary gland, temporal artery, and neuromuscular biopsies. Patients who have undergone these procedures will complete standardized questionnaires regarding their experiences and any side effects at the time of inclusion, as well as at 7 and 30 days post-biopsy. The data collected will be analyzed to evaluate patient tolerance, the adequacy of information received, and potential risk factors for side effects.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who require a biopsy for the diagnosis or follow-up of their autoimmune disease.
Not a fit: Patients who are unable to consent, have dementia, or are under legal protection will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient care by improving the understanding of biopsy tolerance and informing better practices for managing side effects.
How similar studies have performed: While there may be limited data on similar studies, the focus on patient tolerance and information in the context of biopsies for autoimmune diseases is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * biospy required for the diagnsis or follow up aged of more than 18 non opposition form Exclusion Criteria: * unable to consent demencia unable to fill the form and questionnaire patient Under juridical protection refusing to participate
Where this trial is running
Angers and 7 other locations
- CHU d'ANGERS — Angers, France (RECRUITING)
- CHU de Bordeaux — Bordeaux, France (RECRUITING)
- CHRU de Brest — Brest, France (RECRUITING)
- CHU de LILLE — Lille, France (RECRUITING)
- CHU de Marseille — Marseille, France (NOT_YET_RECRUITING)
- Hôpital de la Salpétrière — Paris, France (NOT_YET_RECRUITING)
- CH de Quimper — Quimper, France (NOT_YET_RECRUITING)
- CHU de Tours — Tours, France (RECRUITING)
Study contacts
- Study coordinator: Valérie Devauchelle-Pensec
- Email: valerie.devauchelle-pensec@chu-brest.fr
- Phone: 02-98-34-72-64
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tolerance, Biopsy Site Itching