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SAfety and TOlerance of the Biopsies in Auto-immune Rare dIseases

SAfety and TOlerance of the Biopsies in Auto-immune Rare dIseases

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05022420
Acronym
SATORI
Enrollment
505
Registered
2021-08-26
Start date
2021-08-19
Completion date
2025-03-16
Last updated
2026-06-26

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

Conditions

Biopsy Site Itching, Tolerance

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

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
tolerance of each type of biopsytolerance at day 7 after the biospy was performedtolerance based on a standardized patient 's questionnaire

Secondary

MeasureTime frameDescription
tolerance of each type of biopsy 30 days aftertolerance at day 30 and at inclusion after the biospy was performedtolerance based on a standardized patient 's questionnaire
evaluation of the qualitiy of patient's information at inclusionquestionnaire at inclusionstandardized questionnaire at inclusion
risk factor of sied effect of each biospystandardized questionnaire at inclusion, day 7 and 30standardized questionnaire

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026