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Blood marker may outshine scans for testicular cancer detection

NCT ID NCT07453082

Knowledge-focused Sponsor: Fondazione del Piemonte per l'Oncologia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 observational study is testing whether a blood marker called miRNA371 can detect active germ cell tumors more accurately than standard imaging. Researchers will collect blood samples and perform scans on 100 adults newly diagnosed with germ cell tumors. The goal is to see if this marker can find hidden malignant cells or predict disease progression earlier.

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 simple blood test to detect active germ cell tumors earlier or more accurately than current imaging.
What could go wrong
This is an early observational study, not a treatment trial. The marker may not prove reliable enough for routine use.

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 100 people

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

Started

Jul 2021

Expected to finish

Dec 2026

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 with newly diagnosed testicular germ cell cancers with: 1. Low risk of relapse (5-25% chance of recurrence with active germ cell malignancy). Patients with low risk designation will be assigned to a low intensity schedule of biospecimen collection and imaging requirements. 2. Moderate risk of relapse (26-50% chance of recurrence). Patients with moderate risk designation will be assigned to a higher intensity schedule of biospecimen collection and imaging requirements including early repeat imaging and classic marker determination.

Ages

18 years and older

Sex

Male participants only

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: * Patients must be ≥ 18 years of age. * Patients must have a new diagnosis of a germ cell tumor confirmed pathologically or serologically (diagnostic elevation of HCG/AFP). All primary sites, stages, histological subtypes of germ cell tumor are eligible. Metachronous second primary germ cell tumors are eligible. * If surgery is planned, male patients with Clinical Stage I testicular cancer must have orchiectomy completed within 42 days prior to registration. * Patients must have risk of relapse assessment determined by the local investigator prior to registration. * Patients must have initial imaging, laboratory and other clinical evaluations (see below) performed within 42 days prior to registration. Imaging reports, pathology reports and performance status will be collected. * Patients must have beta-human chorionic gonadotropin (beta-HCG), alpha- fetoprotein (AFP), and lactate dehydrogenase (LDH) assessments within 42 days prior to registration. * Patients must agree to provide informed consent and required blood specimens for the duration of the study. Exclusion Criteria: * Patients with high risk of relapse or metastatic disease. * Patients with tumour assessments beyond the time frame required by the protocol. * Patients not complaint with the protocol schedule.

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Conditions

The condition(s) this trial relates to.

germ cell tumor testicular germ cell tumor

As listed by the trial registrant

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

Testicular germ cell tumor

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Fondazione del Piemonte per l'Oncologia

    RECRUITING

    Candiolo, Turin, 10060, Italy

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