Pathogenic Mechanisms Involved in the Initiation and Prog... | NCT07015060

Studies
Pathogenic Mechanisms Involved in the Initiation and Progression of Systemic Sclerosis

NCT07015060

Sponsor

Université Catholique de Louvain

Status

Not yet recruiting

Last Update Posted

Jun 11, 2025Actual

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Scleroderma (Limited and Diffuse)

Interventions

cutaneous biospy

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

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2025Estimated

Primary Completion Date

Sep 2030Estimated

Completion Date

Mar 2031Estimated

First Submitted Date

May 22, 2025

First Submission Date that Met QC Criteria

Jun 2, 2025

First Posted Date

Jun 11, 2025Actual

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

Jun 2, 2025

Last Update Posted Date

Jun 11, 2025Actual

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

Identify rare variants in candidate genes and pathways identified in familial SSc, in patients with sporadic SSc.

Perform (spatial) transcriptomic and proteomic analyses of affected skin from patients with and without cutaneous fibrosis, for the patterns and levels of expression/activation of candidate genes and pathways.

Test for dysregulation of expression/activation of candidate genes and pathways in live cells isolated from the blood and skin biopsy of patients, and for the impact of these dysregulations on cell appearance, behavior and function.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PathSSc	Other		Procedure: cutaneous biospy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cutaneous biospy	Procedure	cutaneous biospy	PathSSc

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identify rare variants in candidate genes and pathways in SSC patients (blood and skin biopsy)	Genetic analyses in affected skin from patients (Next Generation sequencing, (single cell) RNASeq, real time qPCR)	Through the entire study, approximately during 5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with one of the following:
- Limited SSc
- Limited cutaneous SSc
- Diffuse cutaneous SSc
Patients followed regularly in consultations at CUSL.
Patients between ages 18-80.

Exclusion Criteria:

Other (co-occurring) autoimmune/autoinflammatory disease
Pregnancy
Participants with temporary or definitive disabilities to give consent
Participants unable to sign or read the inform consent form

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Farah Tamirou, Pr	Contact	+32 2 674 53 87		farah.tamirou@saintluc.uclouvain.be

Overall Officials

Name	Affiliation	Role
Nisha Limaye, PhD	Université Catholique de Louvain	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D045743	Scleroderma, Diffuse

Ancestor Terms

ID	Term
D012595	Scleroderma, Systemic
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided