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Blood signatures could reveal who beats breast cancer chemo

NCT ID NCT07880106

Diagnosis Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 19, 2026 · Last updated Oct 20, 2026 · Updated 1 time

Summary

Researchers are exploring whether a panel of blood-based tests can predict how women with breast cancer respond to chemotherapy. The study includes women with early and advanced breast cancer, plus a comparison group of healthy volunteers and women with benign breast lumps. By analyzing immune proteins, tumor DNA, exosomes, and metabolites in blood, the team aims to identify signals linked to complete tumor disappearance after treatment.

What this could mean

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

Active substance
liquid biopsy biomarker testing
What this could lead to
If it works, doctors could use a simple blood test to predict who will respond to chemotherapy and adjust treatment earlier.
What could go wrong
This is an observational study, so it may find patterns that do not hold up in larger groups. Blood biomarkers often fail to predict response reliably across different patients.

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 2,000 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2034

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

Study participants will be selected from three main sources: (1) healthy female volunteers recruited for this study; (2) patients receiving clinical treatment at our institution; and (3) patients undergoing relevant diagnostic or clinical examinations at our institution.

Ages

18 to 80 years

Sex

Anyone

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: Retrospective pan-cancer cohort: 1. Aged 18 to 80 years; 2. Both genders 3. Clinically and histopathologically confirmed diagnosis of solid malignant tumors, including but not limited to non-small cell lung cancer, colorectal cancer, gastric cancer, hepatocellular carcinoma, or breast cancer. 4. Complete clinical data available, including definitive TNM stage and established treatment plan; 5. Archived peripheral blood samples (serum/plasma) collected during routine clinical care. Prospective neoadjuvant chemotherapy (NAC) breast cancer cohort: 1. Female, aged 18 to 80 years (inclusive); 2. Clinically and pathologically confirmed non-metastatic (M0) breast cancer; 3. Planned standard NAC at the study site, with complete pre-treatment ER, PR, and HER2 immunohistochemistry results available; 4. Voluntary participation with signed written informed consent. Prospective metastatic breast cancer cohort: 1. Female, aged 18 to 80 years (inclusive); 2. Clinically and pathologically confirmed metastatic (M1) breast cancer; 3. Planned standard systemic therapy at the study site, with complete ER, PR, and HER2 immunohistochemistry results available; 4. Voluntary participation with signed written informed consent. Benign/Healthy control group: 1. Healthy female volunteers, or female patients with breast fibroadenoma undergoing minimally invasive biopsy during the same period; 2. Voluntary participation with signed written informed consent. Exclusion Criteria: For prospective breast cancer cohorts: 1. History of mastitis, or systemic rheumatic/autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis); 2. Acute or chronic infectious diseases within the past 6 months (e.g., pneumonia, pulmonary tuberculosis, active hepatitis); 3. Long-term use of glucocorticoids, immunosuppressants, biologic agents, or psychotropic medications (short-term or as-needed use excepted); 4. Inability or refusal to provide informed consent.

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Conditions

The condition(s) this trial relates to.

breast cancer breast fibroadenoma breast neoplasm colorectal cancer colorectal neoplasm gastric cancer gastric neoplasm hepatocellular carcinoma non-small cell lung carcinoma

As listed by the trial registrant

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

Breast cancer Colorectal cancer Hepatocellular carcinoma Lung cancer non-small cell Stomach 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

  • Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Shanwei, Guangdong, 516601, China

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