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Can a simple blood test replace colonoscopy for cancer screening?

NCT ID NCT07090291

Diagnosis Sponsor: Zhejiang University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares three ways to screen for colorectal cancer in average-risk people aged 45-74: colonoscopy, a stool test (FIT), and a stool test plus a blood test. Over 60,000 participants will be randomly assigned to one of the three methods. The goal is to see if the simpler tests are as good as colonoscopy at reducing deaths from colorectal cancer over 10 years.

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 show that simpler, non-invasive tests like FIT or a blood test are as effective as colonoscopy for screening, potentially making screening easier and more accessible.
What could go wrong
This is a large trial but results won't be available for 10 years. The blood test is still experimental, and it may not prove as accurate or effective as hoped.

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 60,300 people

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

Started

Aug 2025

Expected to finish

Jul 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.

Ages

45 to 74 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: 45-74 years old; 2. In good general condition, with normal mental state and voluntarily signing the informed consent form; Exclusion Criteria: 1. Personal history of colorectal cancer or precancerous lesions; 2. History of previous colonrectal resection surgery; 3. Diagnosed with cancer before enrollment or currently receiving any cancer-related treatment; 4. Having received colonoscopy, flexible sigmoidoscopy, CT colonography and other examinations within the past 5 years; 5. Having received FIT or FIT-sDNA or cfDNA test within the past 1 year; 6. Symptomatic lower gastrointestinal diseases or symptoms suggesting the need for diagnostic colonoscopy for confirmation; 7. Accompanied by severe diseases that are not suitable for colorectal cancer screening;

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Conditions

The condition(s) this trial relates to.

colorectal neoplasm colorectal adenoma prevention target colorectal cancer prevention target

As listed by the trial registrant

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

Advanced adenoma Colorectal cancer

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

  • Maoming People's Hospital

    RECRUITING

    Guangdong, China

  • Nanjing Medical University

    RECRUITING

    Nanjing, China

  • Shanghai Municipal Center For Disease Control & Prevention

    RECRUITING

    Shanghai, China

  • Sichuan Cancer Hospital & Institute, Sichuan Cancer Center

    RECRUITING

    Sichuan, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guandong, China

  • The Fourth Hospital of Hebei Medical University

    RECRUITING

    Hebei, China

  • Zhejiang Provincial Center for Disease Control and Prevention

    RECRUITING

    Zhejiang, China

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