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Blood test may spot colon cancer return months before scans

NCT ID NCT07795528

Knowledge-focused Sponsor: Ruijin Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This study follows 392 people with stage I-III colon cancer who have had surgery to remove their tumor. Researchers will take blood samples at regular intervals over three years to look for tiny pieces of tumor DNA, called molecular residual disease (MRD). The goal is to see if a positive MRD test after surgery is linked to a higher chance of the cancer coming back, and whether it can warn of recurrence earlier than standard imaging. The findings could help doctors decide who needs extra treatment after surgery.

What this could mean

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

Active substance
Longitudinal ctDNA-MRD NGS testing (blood test for tumor DNA)
What this could lead to
If successful, this could lead to a blood test that detects colon cancer recurrence earlier than scans, and helps doctors tailor adjuvant therapy to each patient's risk.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly improve outcomes. The test's accuracy and clinical utility need validation, and it may not benefit all 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 392 people

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

Started

Aug 2026

Expected to finish

Dec 2030

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

Patients will be selected from consecutive adults evaluated for curative-intent surgery for pathologically confirmed stage I-III colon adenocarcinoma at 10 participating tertiary hospitals in China with colorectal surgery and molecular pathology capabilities. The study cohort will include eligible patients aged 18-75 years whose tumor tissue harbors at least one prespecified oncogenic driver mutation and who consent to serial postoperative blood collection and 3 years of follow-up.

Ages

18 to 75 years

Sex

Anyone

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: 1. Age 18-75 years, regardless of sex 2. Pathologically confirmed colon adenocarcinoma, clinical stage I-III without preoperative endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR) 3. Planned curative surgical resection, no prior anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy) before surgery 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 5. Tumor tissue positive for at least one driver mutation among KRAS, NRAS, BRAF, PIK3CA 6. Voluntary participation with signed written informed consent, good compliance with scheduled follow-up and blood collection. Exclusion Criteria: 1. Received neoadjuvant chemotherapy, radiotherapy or targeted therapy before surgery 2. History of other malignant tumors (excluding non-adenomatous colorectal neoplasms) 3. Pregnant or breastfeeding women 4. Severe concurrent systemic diseases that interfere with long-term follow-up or short-term survival (uncontrolled severe infection, organ failure, mental disorders, or other serious conditions) 5. Abnormal laboratory values or social/family factors judged by investigator to impede sample collection and follow-up 6. Simultaneous participation in other interventional clinical trials with mandatory assigned postoperative treatment regimen

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Conditions

The condition(s) this trial relates to.

colon adenocarcinoma colon carcinoma colonic neoplasm colorectal neoplasm hereditary sensory and autonomic neuropathy malignant colon neoplasm

As listed by the trial registrant

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

Colon adenocarcinoma Stage I colon cancer Stage II colon cancer Stage III colon 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

  • Ruijin Hospital North

    RECRUITING

    Shanghai, Shanghai Municipality, 201801, China

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