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Not yet recruiting NCT07015060

Pathogenic Mechanisms Involved in the Initiation and Progression of Systemic Sclerosis

No phase Interventional Scleroderma (Limited and Diffuse)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cutaneous biospy.
Who it may be relevant to
Registry conditions: Scleroderma (Limited and Diffuse). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure cutaneous biospy
    cutaneous biospy

Primary outcome measures

  • Identify rare variants in candidate genes and pathways in SSC patients (blood and skin biopsy) [Time frame: Through the entire study, approximately during 5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07015060 · PathSSC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗