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Simple blood test could spot hidden liver disease in women

NCT ID NCT07573514

Diagnosis Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a reflex blood test to find primary biliary cholangitis (PBC) earlier in women aged 40 and older. When routine blood work shows certain liver enzyme elevations, the lab automatically checks for antibodies linked to PBC. The goal is to see if this automatic follow-up catches more cases of this often-silent disease, which can lead to cirrhosis if untreated.

What this could mean

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

Active substance
Reflex blood testing (ALP/GGT followed by AMA/ANA)
What this could lead to
If successful, this reflex testing approach could become a standard screening tool to diagnose primary biliary cholangitis earlier, potentially preventing liver damage and improving long-term health.
What could go wrong
This is an observational study, not a treatment trial. It may not prove that earlier diagnosis improves outcomes, and the reflex test could miss some cases or lead to false positives.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,000 people

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

Started

Apr 2026

Expected to finish

Apr 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.

Ages

18 years and older

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: * Female sex, * age ≥ 40 years, * patients attending the pre-hospitalization service for planned admission requiring the measurement of alkaline phosphatase (ALP) and gamma-glutamyl transpeptidase (GGT or gamma-GT) as part of routine clinical practice; * the patient is able to understand the study information and provide informed consent. Exclusion Criteria: * Previous diagnosis of Primary Biliary Cholangitis (PBC) or other liver disease, * patients unable to understand the study information and for whom informed consent cannot be obtained, * patients with known conditions associated with elevated ALP: pregnancy, extrahepatic biliary obstruction (e.g., choledocholithiasis, biliary or pancreatic neoplasms), hepatic neoplasms or metastases, Paget's disease, bone neoplasms or metastases, hyperparathyroidism.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma intrahepatic bile duct cancer liver cancer primary biliary cholangitis

As listed by the trial registrant

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

Cancer liver Intrahepatic bile duct cancer Primary biliary cholangitis

Contacts and locations

Locations

  • Fondazione Policlinico Universitaro A. Gemelli IRCSS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli,

    Roma, 00168, Italy

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