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NCT Number: NCT05532865

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Samples

Other

80 ml of blood samples collected at inclusion and at 18 months

Stool samples

Other

A stool sample for collection of digestive microbiota at inclusion

Skin swab samples

Other

A skin swab sample for collection of skin microbiota at inclusion and at 18 months

Questionnaires on quality of life, pain and disability

Other

At inclusion and each year for 5 years

Skin biopsies

Other

At inclusion and 18 months

Primary outcomes

  1. Age

    Time frame: 5 years

    To assess whether age correlates with disease profile and progression

  2. Sex

    Time frame: 5 years

    To assess whether sex correlates with disease profile and progression

  3. Weight

    Time frame: 5 years

    To assess whether weight correlates with disease profile and progression

  4. Medical history

    Time frame: 5 years

    To assess whether medical history predicts the pattern and course of the disease

  5. Family history

    Time frame: 5 years

    To assess whether family history predicts the pattern and course of the disease

  6. Rodnan score

    Time frame: 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)

  7. active digital ulcers

    Time frame: 5 years

    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.
  8. dyspnea

    Time frame: 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)
  9. Free Carbon Monoxide Diffusion (DLCO)

    Time frame: 5 years

    Free Carbon Monoxide Diffusion (DLCO) in percentage.

  10. 6-minute walk test

    Time frame: 5 years

    Distance (in meters) covered in the 6-minute walk test.

  11. systemic pulmonary arterial pressures

    Time frame: 5 years

    Measured on cardiac ultrasound.

Secondary outcomes

  1. SF-36 (Short-Form 36)

    Time frame: 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
  2. BPI : Pain scale

    Time frame: 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
  3. HAQ- Health Assessment Questionnaire - Disability Index

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Bénédicte ROUVIERE

CONTACT

[email protected]

0033298347345

Claire DE MOREUIL

CONTACT

[email protected]

0033298145303

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: SCLEROBREST

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
Sep 8, 2022
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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