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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Brest

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Minor

Patient under legal protection (guardianship, curatorship)

Refusal to participate

Patient unable to consent

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Blood samples

    Other intervention

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

  • Stool samples

    Other intervention

    A stool sample for collection of digestive microbiota at inclusion

  • Skin swab samples

    Other intervention

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

  • Questionnaires on quality of life, pain and disability

    Other intervention

    At inclusion and each year for 5 years

  • Skin biopsies

    Other intervention

    At inclusion and 18 months

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Adults with systemic sclerosis5 interventions

Trial outcomes

Primary outcomes

1

Age

To assess whether age correlates with disease profile and progression

Time frame
5 years
2

Sex

To assess whether sex correlates with disease profile and progression

Time frame
5 years
3

Weight

To assess whether weight correlates with disease profile and progression

Time frame
5 years
4

Medical history

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

Time frame
5 years

Secondary outcomes

1

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

Time frame
5 years
2

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

Time frame
5 years
3

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

Time frame
5 years

Other outcomes

Sponsors and contacts

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