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AI could spot hidden lung danger in scleroderma patients

NCT ID NCT07236970

Knowledge-focused Sponsor: Alejandro Cruz Utrilla Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether artificial intelligence (AI) can better detect a serious lung condition called pulmonary arterial hypertension (PAH) in people with scleroderma. Researchers will compare AI algorithms to traditional screening methods in 350 patients across multiple hospitals in Spain. The goal is to see if AI can catch PAH earlier and more accurately, which could lead to better outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
artificial intelligence algorithms
What this could lead to
If successful, this could lead to a more accurate, non-invasive screening method for early detection of pulmonary hypertension in scleroderma patients, potentially improving survival and quality of life.
What could go wrong
This is an observational study using existing data and AI models, not a treatment trial. The algorithms may not perform better than current methods, and results may not apply to all patient groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population consists of patients with systemic sclerosis (SSc), with and without pulmonary arterial hypertension (PAH), recruited from the Spanish national PAH registry (REHAP), the systemic sclerosis registry at the Rheumatology Department, and the CSUR national referral unit for pulmonary hypertension at Hospital Universitario 12 de Octubre, as well as participating centers. Cohort 1 (development cohort): 300 SSc patients without PAH and 50 SSc patients with confirmed PAH, retrospectively selected from 2016 to 2024. Cohort 2 (external validation cohort): 200 SSc patients without PAH and 50 with PAH-SSc, prospectively recruited from participating centers and REHAP during the first 2 years of the study. Cohort 3 (prognostic cohort): 100 patients with PAH-SSc prospectively recruited from REHAP and participating centers between January 2025 and December 2026.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years * Clinical diagnosis of systemic sclerosis (SSc) according to ACR/EULAR criteria * For controls (SSc without PAH): absence of pulmonary arterial hypertension; patients with isolated or combined post-capillary pulmonary hypertension (pulmonary capillary pressure \> 15 mmHg) or Group 3 pulmonary hypertension may be included, limited to 20% of this group * For cases (SSc-associated PAH): confirmed PAH by right heart catheterization (mean pulmonary arterial pressure \> 20 mmHg, pulmonary capillary pressure \< 15 mmHg, pulmonary vascular resistance \> 2 Wood Units) Exclusion Criteria: * Missing data in the main variables at diagnosis (clinical assessment, blood tests, electrocardiogram, transthoracic echocardiogram). * Inability to provide informed consent

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Conditions

The condition(s) this trial relates to.

pulmonary hypertension pulmonary systemic sclerosis systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary hypertension Systemic sclerosis (SSC) Systemic sclerosis-associated PAH

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    5 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Madrid, 28041, Spain

  • Hospital Universitario Clínico San Cecilio

    RECRUITING

    Granada, Andalusia, 18007, Spain

    Contact Email: •••••@•••••

  • Hospital Universitario Marqués de Valdecilla

    RECRUITING

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, Madrid, 28034, Spain

  • Hospital Universitario Vall d'Hebron

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

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