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Blood test may predict aneurysm surgery need in marfan patients

NCT ID NCT05700175

Knowledge-focused Sponsor: IRCCS Policlinico S. Donato Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study looks for biological markers in the blood and tissue of adults with Marfan syndrome that could signal when an aortic aneurysm is dangerous enough to require surgery. Researchers will compare three groups of Marfan patients: those without aortic aneurysms, those with stable aneurysms, and those needing surgery. By analyzing gene activity and other molecules, they hope to find a signature that improves current monitoring and treatment decisions.

What this could mean

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

What this could lead to
If successful, this could lead to a blood test that helps doctors predict which Marfan patients need aortic surgery earlier.
What could go wrong
This is an observational study, not a treatment trial. It may not find clear biomarkers, and any future test would require years of additional validation.

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 99 people

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

Started

Nov 2021

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

Patients treated at the IRCCS Policlinico San Donato.

Ages

18 years and older

Sex

Anyone

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: General criteria: * Clinically and genetically determined Marfan syndrome (according to the revised Ghent-criteria 2010) * Signed informed consent * Patient receiving regular pharmacological prophylaxis or newly diagnosed patients Population without thoracic aortic aneurysms (TAA) Patients with clinically and genetically determined Marfan syndrome, presenting thoracic aortic diameters within established normal limits (mm and base Z-score). Population with TAA "stable dimensions" Patients with clinically and genetically determined Marfan syndrome, presenting stable values for dimension / Z-score of the aortic root during the 12 months preceding the enrolment. Population with TAA with surgery indication: * Patients with clinically and genetically determined Marfan syndrome, presenting indication for surgical correctional according to the relevant International guidelines * Trend of uncontrolled increase of aortic diameter compared to previous measurements * Aortic ectasia associated to a clinically significant valve dysfunction * Evaluation of cut-off for surgical intervention dependant also on familial dissection Exclusion Criteria: * Patients with chronic or acute inflammation states, like: chronic liver disease, chronic renal insufficiency (creatinine \> 1.5 mg/dl) and diseases affecting the thyroid apparatus. * Pregnancy

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Conditions

The condition(s) this trial relates to.

Marfan syndrome thoracic aortic aneurysm

As listed by the trial registrant

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

Marfan syndrome Marfan's syndrome with cardiovascular manifestations

Contacts and locations

Locations

  • Irccs Policlinico San Donato

    San Donato Milanese, Milan, 20097, Italy

More trials for these conditions

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