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

Systemic Sclerosis Clinical Trial

— SCLEROBREST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05532865
• Other study ID #: 29BRC21.0258
• Status: Recruiting
• Start date: October 13, 2022
• Est. completion date: October 13, 2032

Study information

• Verified date: April 2023
• Source: University Hospital, Brest
• Contact: Claire DE MOREUIL
• Phone: 0033298145303
• Email: claire.demoreuil[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 13, 2032
• Est. primary completion date: October 13, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Other:
• Blood samples
80 ml of blood samples collected at inclusion and at 18 months
• 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
• Questionnaires on quality of life, pain and disability
At inclusion and each year for 5 years

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age	To assess whether age correlates with disease profile and progression	5 years
Primary	Sex	To assess whether sex correlates with disease profile and progression	5 years
Primary	Weight	To assess whether weight correlates with disease profile and progression	5 years
Primary	Medical history	To assess whether medical history predicts the pattern and course of the disease	5 years
Primary	Family history	To assess whether family history predicts the pattern and course of the disease	5 years
Primary	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
Primary	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
Primary	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
Primary	Free Carbon Monoxide Diffusion (DLCO)	Free Carbon Monoxide Diffusion (DLCO) in percentage.	5 years
Primary	6-minute walk test	Distance (in meters) covered in the 6-minute walk test.	5 years
Primary	systemic pulmonary arterial pressures	Measured on cardiac ultrasound.	5 years
Secondary	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
Secondary	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
Secondary	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