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A blood and stool test could spot digestive cancers before they spread

NCT ID NCT07769892

Diagnosis Sponsor: Xijing 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This study is testing whether a combination of blood and stool biomarkers can accurately screen for cancers of the digestive tract, including stomach, esophagus, and colon. Researchers will collect blood and stool samples from 5,000 people aged 45-74 who are already scheduled for an endoscopy. The test results will be compared against endoscopy and biopsy findings to see how sensitive and specific the new screening method is, with participants followed for five years.

What this could mean

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

Active substance
Combined blood multi-gene methylation test and fecal biomarkers (FIT and calprotectin)
What this could lead to
If successful, this could lead to a simple, non-invasive screening method for early detection of digestive tract cancers, potentially reducing cancer deaths.
What could go wrong
The test may not be accurate enough to replace endoscopy, and early results may not hold up in larger, more diverse populations. False positives or negatives remain a risk.

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 5,000 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2035

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

Eligible subjects shall be aged 45 to 74 years at enrollment, scheduled to receive digestive tract endoscopic screening, willing to complete five-year follow-up as specified by the protocol, and capable of signing the informed consent form.

Ages

45 to 74 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: * 1.Subjects aged 45-74 years at enrollment; 2.Scheduled to undergo digestive tract endoscopic screening; 3.Agree to receive five-year follow-up in accordance with the study protocol; 4.Willing to provide written informed consent. Exclusion Criteria: * 1\. Having received upper gastrointestinal endoscopy within one year; 2.History of any type of malignant tumor; 3.Complicated with severe illnesses that reduce screening benefits, such as severe pulmonary, renal, hepatic, cardiovascular, cerebrovascular and hematological diseases; 4.Other conditions assessed by physicians as excessively high risk for endoscopic screening (e.g., hemodynamic instability) or non-beneficial (short life expectancy); 5.Pregnant or lactating women.

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Conditions

The condition(s) this trial relates to.

digestive system cancer digestive system neoplasm

As listed by the trial registrant

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

Gastrointestinal cancers

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. 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

  • Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province

    RECRUITING

    Zhaoqing, Guangdong, China

  • The 960th Hospital of the Joint Support Force of the People's Liberation Army of China

    RECRUITING

    Jinan, China

  • The First Affiliated Hospital of Air Force Military Medical University

    RECRUITING

    Xi'an, Shaanxi, 710032, China

  • Wuwei Cancer Hospital of Gansu Province

    RECRUITING

    Wuwei, China

  • Wuxi People's Hospital

    RECRUITING

    Wuxi, China

  • Yanting County Tumor Hospital

    RECRUITING

    Mianyang, China

  • Zhaoqing First People's Hospital, Guangdong Province

    RECRUITING

    Zhaoqing, China

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