NCT06472362

Brief Summary

The goal of this retrospective observational study is to investigate whether novel imaging biomarkers of airways, vessels, and overall extent of fibrosis at baseline predict ILD progression, vasculopathy development, and survival in SSc-ILD.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2024

Geographic Reach
4 countries

7 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

June 11, 2024

Last Update Submit

September 4, 2025

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (5)

  • Survival

    Transplant-free survival

    15 years

  • Pulmonary hypertension

    Development of pulmonary hypertension

    15 years

  • Decline in FVC

    Change in lung function measure FVC

    15 years

  • Decline in DLCO

    Change in lung function measure DLCO

    15 years

  • Decline in KCO

    Change in lung function measure KCO

    15 years

Interventions

HRCT biomarkersDIAGNOSTIC_TEST

HRCT imaging biomarkers of airways, vessels, and overall extent of fibrosis

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Secondary/tertiary care patients with SSc

You may qualify if:

  • diagnosed with SSc
  • ≥18 years old
  • HRCT between 01/01/1990 and 31/12/2019

You may not qualify if:

  • Patients who do not have SSc
  • \<18 years old
  • lack of availability of HRCT imaging data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Bichat-Claude Bernard hospital

Paris, France

Location

Hanover Medical School

Hanover, Germany

Location

Marche Polytechnic University

Ancona, Italy

Location

Sassari University

Sassari, Italy

Location

Siena University Hospital

Siena, Italy

Location

Leeds Hospital/University of Leeds

Leeds, United Kingdom

Location

Royal Brompton Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Elisabetta A Renzoni

    Royal Brompton and Harefield Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 25, 2024

Study Start

November 1, 2024

Primary Completion

December 1, 2025

Study Completion

March 31, 2026

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(3)GB(2)FR(1)DE(1)