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Tiny particles in blood may reveal how well breast cancer chemo works

NCT ID NCT05831397

Diagnosis Sponsor: Istituti Clinici Scientifici Maugeri SpA Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study explores whether tiny particles called extracellular vesicles (EVs) in the blood can serve as a diagnostic and prognostic tool for breast cancer patients undergoing chemotherapy. Researchers will measure EV levels using a highly sensitive technology (SiMoA) in 35 women with breast cancer and compare them to healthy controls. The goal is to see if EV levels change during treatment and can predict how well the chemotherapy works.

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 guide breast cancer treatment decisions.
What could go wrong
This is a small, early-stage study. The new detection method 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 35 people

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

Started

May 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

* Population 1: female patients diagnosed with breast cancer, at any TNM stage, who are candidate to neoadjuvant treatment. * Population 2: a control group of sex and age matched healthy volunteers, not affected by breast cancer (with negative mammography, breast ultrasound or clinical breast examination within 12 months of the study enrolment).

Ages

18 to 80 years

Sex

Female participants only

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 BC patients: * Diagnosis of breast cancer * Any TNM stage * Indication to neoadjuvant chemotherapy after multidisciplinary discussion Healthy controls: • Patients with a negative mammography, breast ultrasound or clinical breast evaluation within 12 months of the study enrolment Exclusion Criteria: BC patients: • Indication to upfront surgery Healthy controls: • Diagnosis of breast cancer

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Conditions

The condition(s) this trial relates to.

breast cancer 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

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Contacts and locations

Locations

  • Istituti Clinici Scientifici Maugeri SpA

    RECRUITING

    Pavia, Lombardy, 27100, Italy

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