Implementation of a Biological Sample Collection in Syste... | NCT04986514

Studies
Implementation of a Biological Sample Collection in Systemic Sclerosis Patients

NCT04986514

Sponsor

University Hospital, Lille

Status

Withdrawn

Last Update Posted

May 4, 2026Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Systemic Sclerosis

Interventions

Bio-banking without genetic analysis

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2021-A00107-34	Other Identifier	ID-RCB number, ANSM

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

withdrawed by the sponsor. A concurrent study is currently underway in the department

Expanded Access Info

Start Date

Apr 2023Estimated

Primary Completion Date

Apr 2043Estimated

Completion Date

Apr 2043Estimated

First Submitted Date

Jul 22, 2021

First Submission Date that Met QC Criteria

Jul 22, 2021

First Posted Date

Aug 3, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2026

Last Update Posted Date

May 4, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Systemic sclerosis (SSc) is the most severe of the systemic autoimmune diseases. It is characterized by skin and organ fibrosis (mainly interstitial lung disease, which affects 40-50% of patients), as well as severe vascular complications such as pulmonary hypertension (5-10%), renal crisis (2%), and digital gangrene (5%). There are currently no validated prognostic biomarkers for the progression of SSc, yet it is crucial to better predict the progression of SSc to optimize patient management, but also to identify the optimal population for clinical trials ("progressor" patients). Furthermore, there are no validated biomarkers of response to immunosuppressive therapies that would be useful both in patient management and in the evaluation of new treatments in clinical trials. The internal medicine department of the Lille University Hospital is a national and European reference center for the management of patients with SSc. Nearly 500 patients are followed annually in the internal medicine department. As part of their routine care, patients are hospitalized in average once a year in the internal medicine department of the Lille University Hospital for a complete assessment of their SSc. This assessment includes a detailed medical observation, complementary examinations and blood and urine biology tests. The purpose of this study would be to collect 2 additional blood samples during the standard evaluation of scleroderma patients. The main objective of this collection of biological samples for scientific research will be the identification of new biomarkers associated with prognosis and treatment response to improve the management of SSc patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with systemic sclerosis			Other: Bio-banking without genetic analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bio-banking without genetic analysis	Other	For patients included in SCLERO-BIOBANK study, 2 blood samples will be collected at each SSc evaluation (usually once a year), in addition to the routine care blood collection.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence during the follow-up period of an aggravation defined as death, onset or worsening of organ damage	Identify biomarkers that are associated with disease prognosis and treatment response during 10 years of follow-up.	Through study completion an average of 10 years

Secondary Outcomes

Measure	Description	Time Frame
EUSTAR score	Identify new biomarkers associated with disease severity and disease activity at study entry and the evolution of disease severity and activity over time	Baseline and through study completion, an average of 10 years
Medsger score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient followed for SSc in the internal medicine or cardiology department of the Lille University Hospital
Fulfilling the ACR/EULAR and/or VEDOSS criteria for SSc
Being insured by the French social security system
Having the ability to understand the requirements of the study and provide informed consent

Exclusion Criteria:

Administrative reasons: unable to receive informed information, lack of social security coverage
Pregnant or lactating women
Persons deprived of liberty
Minors or protected adults
Persons who have refused or are unable to give informed consent
Persons in emergency situations

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient followed for SSc in the internal medicine or cardiology department of the Lille University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Launay, MD,PhD	University Hospital, Lille	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012595	Scleroderma, Systemic

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005820	Genetic Testing

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided