NCT07283081

Brief Summary

The investigators hypothesize that in patients with a new diagnosis of Pulmonary Interstitial Disease (PID), adding capillaroscopy to standard care increases the proportion of patients receiving a diagnosis of PID-Connective Tissue Disease (PID-CTD) within the first three months of follow-up, thereby reducing the time to diagnosis and facilitating the implementation of appropriate treatment as quickly as possible. Therefore, To confirm this hypothesis, it is necessary to know the characteristics of capillaroscopy in patients with a new diagnosis of PID.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

December 2, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

March 16, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

December 2, 2025

Last Update Submit

March 17, 2026

Conditions

Keywords

Pulmonary Interstitial DiseasecapillaroscopyConnective Tissue Diseasediagnosis

Outcome Measures

Primary Outcomes (1)

  • Proportion of capillaroscopy abnormalities according to the classification proposed by the EULAR Study Group on Microcirculation in Rheumatic Diseases

    At baseline (Day 0)

Secondary Outcomes (4)

  • Description of the criteria that may influence the results of capillary examination: proportion of smoking status categories (active smoker/non-smoker/former smoker) and number of cigarettes per day for active smokers

    At baseline (Day 0)

  • Description of the criteria that may influence the results of capillary examination: number of cigarettes per day for active smokers

    At baseline (Day 0)

  • Description of the criteria that may influence the results of capillary examination: proportion of patients who consume alcohol

    At baseline (Day 0)

  • Description of the criteria that may influence the results of capillary examination: average number of standard drinks for active consumers.

    At baseline (Day 0)

Study Arms (1)

Diffuse interstitial lung diseases (DILD)

EXPERIMENTAL
Diagnostic Test: capillaroscopy

Interventions

capillaroscopyDIAGNOSTIC_TEST

Capillaroscopy will be performed during a specific consultation. During this examination, a device called a "video capillaroscope" is used to magnify and visualize the capillaries located at the base of the nail. The examination lasts approximately twenty minutes.

Diffuse interstitial lung diseases (DILD)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female over 18 years of age;
  • Have received a new diagnosis of PID within the last six months, confirmed by a pulmonologist;
  • Have undergone some specific tests within the last six months (Chest CT scan, respiratory function tests (plethysmography and CO transfer capacity measurement, immunological assessment including: screening for FAN, FR, and anti-CCP);
  • French-speaking patient with no comprehension difficulties;
  • Person affiliated with or beneficiary of a social security system;

You may not qualify if:

  • Have previously undergone a capillaroscopy, regardless of the reason;
  • Have a diagnosis or high suspicion of connective tissue disease based on initial clinical and paraclinical evaluation;
  • Have already started one of the following treatments for pulmonary involvement: systemic corticosteroids, immunosuppressive therapy, antifibrotic therapy;
  • Pregnant or breastfeeding women;
  • Patients covered by Articles L 1121-5 to L 1121-8 (persons deprived of their liberty by judicial or administrative decision, minors, adults subject to legal protection measures, or persons unable to give their consent).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux - service de rhumatologie

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Lung Diseases, InterstitialConnective Tissue DiseasesDisease

Interventions

Microscopic Angioscopy

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Intravital MicroscopyMicroscopyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, CardiovascularInvestigative Techniques

Study Officials

  • Marie-Elise TRUCHETET, MD, PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Elise TRUCHETET, MD, PhD

CONTACT

Thomas BARNETCHE, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2025

First Posted

December 15, 2025

Study Start

March 16, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations