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Can a simple test predict breast Cancer's next move?

NCT ID NCT07372261

Knowledge-focused Sponsor: Casa Sollievo della Sofferenza 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new tool called PORTENT that uses tumor samples and patient history to estimate the risk of breast cancer spreading (metastasis) in people with early-stage disease. Researchers will analyze tissue from 1000 patients and track their health for up to 10 years. The goal is to see if the algorithm can accurately identify who is most likely to develop distant metastases, which could guide more personalized 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 more accurate tool to predict which early-stage breast cancer patients are at risk of metastasis, helping tailor follow-up care.
What could go wrong
This is an observational study, not a treatment trial. The algorithm may not prove accurate enough for widespread use, 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 1,000 people

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

Started

Mar 2022

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

The study includes three cohorts: CSS-cohort\_2: 350 cases with ≥5 years follow-up, prospectively enrolled 2014-2019 within the TRANSCAN-BREMIR Study (Refs: Prot 116/CE 30/09/2014; Prot 140/CE 28/10/2014; Prot 150/CE 24/10/2018). External cohort: ≥450 patients with available residual tumor tissue, retrospectively selected; each center enrolls ≥75 patients (60 disease-free ≥5 years, 15 with metastatic progression ≥3 years). INT\_Milan cohort: 300 Luminal A breast cancer cases treated with neoadjuvant therapy, with pre-treatment and/or surgical residual tumor tissue available.

Ages

18 years and older

Sex

Female 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: * Stage I-III breast cancer * Residual tumor tissue available * Written informed consent Exclusion Criteria: * Age \<18 * Stage IV at diagnosis * Refusal or inability to provide informed consent

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Conditions

The condition(s) this trial relates to.

breast cancer Neoplasm Metastasis

As listed by the trial registrant

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

Breast cancer early stage breast cancer (stage 1-3)

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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 Casa Sollievo della Sofferenza IRCCS

    San Giovanni Rotondo, FG, 71013, Italy

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