CHRU de Brest
Brest, 29200, France
Location status: Recruiting
Location contact
BENEDICTE ROUVIERE
CONTACT
CLAIRE DE MOREUIL
CONTACT
NCT Number: NCT05532865
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Brest, 29200, France
Location status: Recruiting
BENEDICTE ROUVIERE
CONTACT
CLAIRE DE MOREUIL
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
80 ml of blood samples collected at inclusion and at 18 months
A stool sample for collection of digestive microbiota at inclusion
A skin swab sample for collection of skin microbiota at inclusion and at 18 months
At inclusion and each year for 5 years
At inclusion and 18 months
Time frame: 5 years
To assess whether age correlates with disease profile and progression
Time frame: 5 years
To assess whether sex correlates with disease profile and progression
Time frame: 5 years
To assess whether weight correlates with disease profile and progression
Time frame: 5 years
To assess whether medical history predicts the pattern and course of the disease
Time frame: 5 years
To assess whether family history predicts the pattern and course of the disease
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)
Time frame: 5 years
4 characteristics must be taken into account:
Time frame: 5 years
Time frame: 5 years
Free Carbon Monoxide Diffusion (DLCO) in percentage.
Time frame: 5 years
Distance (in meters) covered in the 6-minute walk test.
Time frame: 5 years
Measured on cardiac ultrasound.
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:
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 :
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
Contact information is provided by the study sponsor or research team.
Bénédicte ROUVIERE
CONTACT
Claire DE MOREUIL
CONTACT
University Hospital, Brest
Other
Prospective Cohort of Patients With Systemic Sclerosis at Brest University Hospital and Constitution of a Biobank
Acronym: SCLEROBREST
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.
Published trials that share one or more normalized conditions with this study.
NCT06947460
Autoimmune Diseases, Connective Tissue Diseases
Beijing, China,Beijing, China
View Trial DetailsNCT07295847
Arthritis, Arthritis, Rheumatoid
Tucson, Arizona, United States
View Trial DetailsNCT07085104
Autoimmune Diseases, Connective Tissue Diseases
Phoenix, Arizona, United States
View Trial DetailsNCT06925542
Autoimmune Diseases, Connective Tissue Diseases
Redwood City, California, United States
View Trial Details