Prospective Cohort of Patients With Systemic Sclerosis at Brest University Hospital With Biobanking (SCLEROBREST)

Prospective Cohort of Patients With Systemic Sclerosis at Brest University Hospital and Constitution of a Biobank

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.

Study Overview

• Status: Recruiting
• Conditions: Systemic Sclerosis
• Intervention / Treatment: Other: Blood samples; Other: Stool samples; Other: Skin swab samples; Other: Questionnaires on quality of life, pain and disability

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: CLAIRE DE MOREUIL; Phone Number: 0033298145303; Email: claire.demoreuil@chu-brest.fr
• Study Contact Backup: Name: BENEDICTE ROUVIERE; Phone Number: 0033298347345; Email: benedicte.rouviere@chu-brest.fr

Study Locations

• France
  • Brest, France, 29200
    • Recruiting
    • CHRU de Brest
    • Contact: CLAIRE DE MOREUIL; Phone Number: 0033298145303; Email: claire.demoreuil@chu-brest.fr
    • Contact: BENEDICTE ROUVIERE; Phone Number: 0033298347345; Email: benedicte.rouviere@chu-brest.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Major patient with systemic sclerosis defined according to the EULAR 2013 criteria

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Minor
• Patient under legal protection (guardianship, curatorship)
• Refusal to participate
• Patient unable to consent
• Pregnant or breastfeeding woman
• Hemoglobin (Hb) level < 7g/dl

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adults with systemic sclerosis; It is a descriptive cohort of systemic sclerosis patients	Other: Blood samples; 80 ml of blood samples collected at inclusion and at 18 months; Other: Stool samples; A stool sample for collection of digestive microbiota at inclusion; Other: Skin swab samples; A skin swab sample for collection of skin microbiota at inclusion and at 18 months; Other: Questionnaires on quality of life, pain and disability; At inclusion and each year for 5 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: the type of ulcer: mechanical/on calcinosis/ischemic; the recent/semi-recent/chronic character,; the painful character or not,; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36 (Short-Form 36)	The SF-36 is an indicator of health status and quality of life. The SF-36 has eight dimensions; the scores are weighted sums of the questions in each section. This scores range from 0 - 100. Lower scores indicate more disability and higher scores less disability. The eight dimensions of this score are: Vitality; Physical functioning; Bodily pain; General health perceptions; Physical role functioning; Emotional role functioning; Social role functioning; Mental health	5 years
BPI : Pain scale	A quick and easy way to measure the intensity of pain and its impact on daily activities. Patients rate the maximum, minimum, average and current intensity of their pain and the influence of pain on seven aspects of functional ability. 3 scores are obtained between 0 and 10, with 10 corresponding to : the worst pain experienced in the last 24 hours; the highest pain intensity combining the most intense, the least intense, the average pain and the pain experienced at the time of the questionnaire; the highest interference of the pain on daily activities	5 years
HAQ- Health Assessment Questionnaire - Disability Index	Evolution of HAQ-DI (Health Assessment Questionnaire - Disability Index) during follow-up 8 fields questionnaire (DRESSING & GROOMING, ARISING, EATING, WALKING, HYGIENE, REACH, GRIP, Other activities), scaled from 0 to 3, 3 meaning a worse outcome	5 years

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2022
• Primary Completion (Anticipated): October 13, 2032
• Study Completion (Anticipated): October 13, 2032

Study Registration Dates

• First Submitted: September 5, 2022
• First Submitted That Met QC Criteria: September 5, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Systemic Sclerosis; Patient library
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Connective Tissue Diseases; Sclerosis; Scleroderma, Systemic; Scleroderma, Diffuse
• Other Study ID Numbers: 29BRC21.0258

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No