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Could a simple blood test spot breast cancer earlier?

NCT ID NCT05798338

Diagnosis Sponsor: Istituti Clinici Scientifici Maugeri SpA 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Updated 2 times

Summary

This study is testing a new, highly sensitive blood test to measure tiny particles called extracellular vesicles that are released by breast cancer cells. Researchers will compare levels in women with early or metastatic breast cancer to healthy controls. The goal is to see if this test can help diagnose breast cancer or monitor treatment response without needing a tissue biopsy.

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 help detect breast cancer earlier or track how it responds to treatment.
What could go wrong
This is an early-stage study with only 105 participants, so the test may not prove accurate enough for widespread use. It is not a treatment study.

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 105 people

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

Started

Dec 2020

Expected to finish

Sep 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

Breast cancer patients

Ages

18 to 90 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Signing of a specific informed consent for participation to the study * Female sex Population 1: * Diagnosis of early breast cancer; * Indication for surgery after multidisciplinary discussion. Population 2: \- Patients having a negative mammography or breast ultrasound within 12 months from the study enrollment. Population 3: * Diagnosis of metastatic breast cancer confirmed by cytological/histological examination or by imaging; * Indication to chemotherapy. Exclusion Criteria: Population 1: * Presence of distant metastases * Synchronous presence of a different tumor * Indication to neoadjuvant chemotherapy Population 2: * Diagnosis of breast cancer * Synchronous presence of a different tumor or chronic disease Population 3: \- Patients who are unfit for systemic chemotherapy treatment

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm

As listed by the trial registrant

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

Breast cancer

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

  • Istituti Clinici Scientifici Maugeri SpA

    RECRUITING

    Pavia, Lombardy, 27100, Italy

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