SAfety and TOlerance of the Biopsies in Auto-immune Rare dIseases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University Hospital, Brest
- Enrollment
- 505
- Locations
- 8
- Primary Endpoint
- tolerance of each type of biopsy
Study Overview
Brief Summary
Biopsies are performed in several autoimmune diseases to diagnose or classify them Tolerance and information of the patients have been poorly evlauated our objective is to evaluate tolerance and information of the patients after the biopsies for salivary gland, temporal arteries and neuromuscular.
Detailed Description
patinets that benefited of arterial temporal biospy or salivary gland biospy or muscuar biopsy or neuro muscular biospy for his auto -mmune disease will be included and fill standardized questionnaires concerning tolerance, information and side effect at inclusion , day 7 and day 30 after the biopsy data will be analysed to evaluate information, tolerance and risk factor af side effect
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
neuro muscular biospy
neuro muscular biospy use for the diagnosis of vasculitis,muscular auto-immune disease or neuro-muscumar auto-immune disease
temporal arteries biospy
temporal arteries biospy uses for the diagnosis of giant cell arteritis
Salivary gland biospy,
100 Salivary gland biospy use for the diagnosis of sjogern disease or other auto-immune disease.
muscular biopsy,
muscular biospy use for the diagnosis of muscular auto-immune disease.
Outcomes
Primary Outcomes
tolerance of each type of biopsy
Time Frame: tolerance at day 7 after the biospy was performed
tolerance based on a standardized patient 's questionnaire
Secondary Outcomes
- evaluation of the qualitiy of patient's information at inclusion(questionnaire at inclusion)
- tolerance of each type of biopsy 30 days after(tolerance at day 30 and at inclusion after the biospy was performed)
- risk factor of sied effect of each biospy(standardized questionnaire at inclusion, day 7 and 30)