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

Recruiting

• Conditions: Systemic Sclerosis
• Interventions: Other: Blood samples; Other: Stool samples; Other: Skin swab samples; Other: Questionnaires on quality of life, pain and disability; Other: Skin biopsies

• Registration Number: NCT05532865
• Lead Sponsor: University Hospital, Brest

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-05
• Study First Submitted QC: 2022-09-05
• Study First Posted: 2022-09-08
• Study Start: 2022-10-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Primary Completion: 2032-10-13
• Study Completion: 2032-10-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults with systemic sclerosis	Stool samples	It is a descriptive cohort of systemic sclerosis patients
Adults with systemic sclerosis	Skin biopsies	It is a descriptive cohort of systemic sclerosis patients
Adults with systemic sclerosis	Blood samples	It is a descriptive cohort of systemic sclerosis patients
Adults with systemic sclerosis	Skin swab samples	It is a descriptive cohort of systemic sclerosis patients
Adults with systemic sclerosis	Questionnaires on quality of life, pain and disability	It is a descriptive cohort of systemic sclerosis patients

Primary Outcome Measures

Name	Time	Method
Age	5 years	To assess whether age correlates with disease profile and progression
Medical history	5 years	To assess whether medical history predicts the pattern and course of the disease
dyspnea	5 years	* 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)
Weight	5 years	To assess whether weight correlates with disease profile and progression
active digital ulcers	5 years	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.
6-minute walk test	5 years	Distance (in meters) covered in the 6-minute walk test.
systemic pulmonary arterial pressures	5 years	Measured on cardiac ultrasound.
Sex	5 years	To assess whether sex correlates with disease profile and progression
Family history	5 years	To assess whether family history predicts the pattern and course of the disease
Rodnan score	5 years	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)
Free Carbon Monoxide Diffusion (DLCO)	5 years	Free Carbon Monoxide Diffusion (DLCO) in percentage.

Secondary Outcome Measures

Name	Time	Method
SF-36 (Short-Form 36)	5 years	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
BPI : Pain scale	5 years	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
HAQ- Health Assessment Questionnaire - Disability Index	5 years	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

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France