ToleranceSATORINCT05022420
SAfety and TOlerance of the Biopsies in Auto-immune Rare dIseases
An observational study of Tolerance and Biopsy Site Itching, run by University Hospital, Brest at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tolerance, Biopsy Site Itching
- How many people
- 505 participants
- Where
- 8 sitesFrance
- Study dates
- 19 Aug 2021to 16 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients that underwent a biospy for his auto-immune rare disease
Who may be able to join
- biospy required for the diagnsis or follow up aged of more than 18 non opposition form
Who cannot join
- unable to consent demencia unable to fill the form and questionnaire patient Under juridical protection refusing to participate
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU d'ANGERS
Angers
CHU de Bordeaux
Bordeaux, 33000
CHRU de Brest
Brest, 29609
CHU de LILLE
Lille, 59037
CHU de Marseille
Marseille
Hôpital de la Salpétrière
Paris, 75013
CH de Quimper
Quimper, 20007
CHU de Tours
Tours
About this study
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.
Read the 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
- Conditions
- Tolerance, Biopsy Site Itching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
tolerance of each type of biopsy
tolerance based on a standardized patient 's questionnaire
Measured: tolerance at day 7 after the biospy was performed
Secondary outcomes (3)
tolerance of each type of biopsy 30 days after
tolerance based on a standardized patient 's questionnaire
Measured: tolerance at day 30 and at inclusion after the biospy was performed
evaluation of the qualitiy of patient's information at inclusion
standardized questionnaire at inclusion
Measured: questionnaire at inclusion
risk factor of sied effect of each biospy
standardized questionnaire
Measured: standardized questionnaire at inclusion, day 7 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start19 Aug 2021
- Primary completion16 Mar 2025
- Study completion16 Mar 2025
Why it stopped: Insufficient accrual. Recruitment was stopped because enrollment targets were unlikely to be achieved. A total of 505 of 600 planned participants were enrolled. Data will be included in planned pooled analyses.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToleranceStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022420
- Sponsor's protocol ID
- SATORI (29BRC21.0089)
- Acronym
- SATORI
- Status last verified
- Apr 2024
- First submitted
- 25 Aug 2021
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAfety and TOlerance of the Biopsies in Auto-immune Rare dIseases
- ClinicalTrials.gov ID
- NCT05022420
- Acronym / sponsor ID
- SATORI / SATORI (29BRC21.0089)
- Conditions
- Tolerance, Biopsy Site Itching
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient accrual. Recruitment was stopped because enrollment targets were unlikely to be achieved. A total of 505 of 600 planned participants were enrolled. Data will be included in planned pooled analyses.
- Enrolment
- 505 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 16 Mar 2025 (actual)
- Study completion
- 16 Mar 2025 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients that underwent a biospy for his auto-immune rare disease
Key inclusion criteria (1 listed)
- biospy required for the diagnsis or follow up aged of more than 18 non opposition form
Key exclusion criteria (1 listed)
- unable to consent demencia unable to fill the form and questionnaire patient Under juridical protection refusing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
tolerance of each type of biopsy 30 days after
Time frame: tolerance at day 30 and at inclusion after the biospy was performed
evaluation of the qualitiy of patient's information at inclusion
Time frame: questionnaire at inclusion
risk factor of sied effect of each biospy
Time frame: standardized questionnaire at inclusion, day 7 and 30
Results and safety
The study was stopped early (reason given: Insufficient accrual. Recruitment was stopped because enrollment targets were unlikely to be achieved. A total of 505 of 600 planned participants were enrolled. Data will be included in planned pooled analyses.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tolerance and Biopsy Site Itching, run by University Hospital, Brest at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient accrual. Recruitment was stopped because enrollment targets were unlikely to be achieved. A total of 505 of 600 planned participants were enrolled. Data will be included in planned pooled analyses.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tolerance of each type of biopsy (time frame: tolerance at day 7 after the biospy was performed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.