Pathogenic Mechanisms Involved in the Initiation and Progression of Systemic Sclerosis

NCT ID: NCT07015060

Last Updated: 2025-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2031-03-31

Brief Summary

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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

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Conditions

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Scleroderma (Limited and Diffuse)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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PathSSc

Group Type OTHER

cutaneous biospy

Intervention Type PROCEDURE

cutaneous biospy

Interventions

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cutaneous biospy

cutaneous biospy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nisha Limaye, PhD

Role: STUDY_DIRECTOR

Université Catholique de Louvain

Central Contacts

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Farah Tamirou, Pr

Role: CONTACT

+32 2 674 53 87

Other Identifiers

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PathSSC

Identifier Type: -

Identifier Source: org_study_id

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