Prospective Cohort of Patients With Systemic Sclerosis at Brest University Hospital With Biobanking
SCLEROBREST
1 other identifier
observational
100
1 country
1
Brief Summary
This study corresponds to a monocentric prospective cohort of adult patients with systemic sclerosis. It will allow the constitution of an organized collection of longitudinal clinical data as well as collection of biological samples, including blood samples, as well as stool sample and skin swab for microbiota analysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2022
CompletedFirst Posted
Study publicly available on registry
September 8, 2022
CompletedStudy Start
First participant enrolled
October 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 13, 2032
August 7, 2024
August 1, 2024
10 years
September 5, 2022
August 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
Age
To assess whether age correlates with disease profile and progression
5 years
Sex
To assess whether sex correlates with disease profile and progression
5 years
Weight
To assess whether weight correlates with disease profile and progression
5 years
Medical history
To assess whether medical history predicts the pattern and course of the disease
5 years
Family history
To assess whether family history predicts the pattern and course of the disease
5 years
Rodnan score
This score evaluates the thickness of the skin from 0 to 51. 0 meaning the absence of scleroderma (the healthiest score) and 51 completely sclerotic skin (the worst possible score)
5 years
active digital ulcers
4 characteristics must be taken into account: 1. the type of ulcer: mechanical/on calcinosis/ischemic 2. the recent/semi-recent/chronic character, 3. the painful character or not, 4. the total number of fingers affected on the 10 fingers.
5 years
dyspnea
* stage I: absence of dyspnea for usual efforts: no discomfort is felt in everyday life, * stage II: dyspnoea for usual heavy exertion, such as brisk or hill walking or climbing stairs (≥ 2 floors), * stage III: dyspnea for low intensity efforts of everyday life, such as walking on flat ground or climbing stairs (\< 2 floors), * stage IV: permanent dyspnea at rest or for minimal effort (putting on a garment, for example)
5 years
Free Carbon Monoxide Diffusion (DLCO)
Free Carbon Monoxide Diffusion (DLCO) in percentage.
5 years
6-minute walk test
Distance (in meters) covered in the 6-minute walk test.
5 years
systemic pulmonary arterial pressures
Measured on cardiac ultrasound.
5 years
Secondary Outcomes (3)
SF-36 (Short-Form 36)
5 years
BPI : Pain scale
5 years
HAQ- Health Assessment Questionnaire - Disability Index
5 years
Study Arms (1)
Adults with systemic sclerosis
It is a descriptive cohort of systemic sclerosis patients
Interventions
80 ml of blood samples collected at inclusion and at 18 months
A stool sample for collection of digestive microbiota at inclusion
A skin swab sample for collection of skin microbiota at inclusion and at 18 months
At inclusion and each year for 5 years
Eligibility Criteria
Major patient with systemic sclerosis defined according to the EULAR 2013 criteria
You may qualify if:
- Major patient with systemic sclerosis defined according to the EULAR 2013 criteria (see Appendix 1)
- Patient evaluated within the framework of the reference center for rare autoimmune diseases of the CHU of Brest.
- Patient affiliated to the social security system
- Patient having signed a written informed consent.
You may not qualify if:
- Minor
- Patient under legal protection (guardianship, curatorship)
- Refusal to participate
- Patient unable to consent
- Pregnant or breastfeeding woman
- Hemoglobin (Hb) level \< 7g/dl
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU de Brest
Brest, 29200, France
Biospecimen
Blood samples 80 ml of blood samples collected at inclusion and at 18 months ((60 ml for Peripheral blood mononuclear cell, 6 ml for plasma, 6 ml for sero, 6 ml for DNA and 2.5 ml for RNA) Stool samples A stool sample for collection of digestive microbiota at inclusion Skin swab samples A skin swab sample for collection of skin microbiota at inclusion and at 18 months Skin biopsy (optional) at inclusion and at 18 months Questionnaires on quality of life, pain and disability At inclusion and each year for 5 years
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2022
First Posted
September 8, 2022
Study Start
October 13, 2022
Primary Completion (Estimated)
October 13, 2032
Study Completion (Estimated)
October 13, 2032
Last Updated
August 7, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
- Access Criteria
- Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement
All collected data that underlie results in a publication