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New device hunts for wandering cancer cells to predict relapse

NCT ID NCT05360290

Knowledge-focused Sponsor: RenJi Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a device called GILUPI CellCollector® that captures circulating tumor cells (CTCs) from a vein in breast cancer patients who have already completed surgery and chemotherapy. The goal is to see if the presence of these cells can help predict whether the cancer will come back. About 484 women will take part across multiple hospitals, and researchers will track their health for several years.

What this could mean

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

Active substance
GILUPI CellCollector® (a medical device that captures circulating tumor cells from a vein)
What this could lead to
If successful, this could help doctors better predict which breast cancer patients are at higher risk of their cancer returning after surgery and neoadjuvant treatment.
What could go wrong
This is an observational study, not a treatment trial. The device is already approved, but it is unclear if measuring these cells will actually improve patient outcomes or change how doctors manage care.

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 484 people

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

Started

Sep 2022

Expected to finish

Jun 2029

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 to 70 years

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: * Female, aged ≥18 and ≤70 years; * Histologically confirmed invasive breast cancer (cT2-4N0-2M0 or cT1N1-3M0 before neoadjuvant treatment); * Completed neoadjuvant treamtment and surgery (within 4 years after surgery); * Administered neoadjuvant chemotherapy (regardless of chemotherapy regimen); * ECOG 0-1 Exclusion Criteria: * Metastatic disease (Stage IV); * Female patients who are pregnancy or lactation; * Uncontrollable puncture site infection or systemic infection;

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm invasive breast carcinoma Neoplastic Cells, Circulating

As listed by the trial registrant

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

Breast cancer Circulating tumor cell

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

  • Renji Hospital, School of Medicine, Shanghai Jiao Tong University

    RECRUITING

    Shanghai, Shanghai Municipality, 200127, China

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