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Blood test could spot returning colon cancer months before scans

NCT ID NCT04084249

Knowledge-focused Sponsor: Claus Lindbjerg Andersen Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a simple blood test that looks for tumor DNA can detect colorectal cancer coming back earlier than standard CT scans. About 359 people who had surgery for stage II or III colorectal cancer will be randomly assigned to either the blood test plus frequent PET/CT scans or standard follow-up. The goal is to see if the blood test helps more patients get curative treatment when the cancer returns.

What this could mean

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

Active substance
ctDNA blood test
What this could lead to
If successful, this approach could help detect cancer recurrence earlier and allow more patients to have surgery or other treatments that aim for a cure.
What could go wrong
This is a relatively early-stage study, and the blood test may not be accurate enough to replace standard scans. It also may not improve survival or quality of life.

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

359 people

The number who actually took part.

Started

Jan 2020

Expected to finish

Jun 2028

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 years and older

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: * Colon or rectal cancer, tumor stage III (pT1-4N1-2,cM0) or stage II high-risk (pT4N0,cM0 and pT3N0, cM0 with risk factors) * Have received curative intend resection and be candidates for adjuvant chemotherapy Exclusion Criteria: * Not treated with adjuvant chemotherapy * Synchronous colorectal and non-colorectal cancer diagnosed per-operative (except skin cancer other than melanoma) * Other cancers (excluding colorectal cancer or skin cancer other than melanoma) within 3 years from screening * Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study.

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Conditions

The condition(s) this trial relates to.

colon carcinoma colonic disorder colonic neoplasm colorectal cancer colorectal neoplasm digestive system cancer Digestive System Diseases digestive system disorder digestive system neoplasm Digestive System Neoplasms intestinal disorder rectal cancer rectal disorder rectal neoplasm

As listed by the trial registrant

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

Colo-rectal cancer Colonic cancer Colonic diseases Colonic neoplasms Colorectal cancer Colorectal neoplasms CTDNA Digestive system disease Digestive system neoplasm Gastro-intestinal disorder Gastrointestinal cancer Gastrointestinal neoplasms Rectal cancer Rectal diseases Rectal neoplasms

Contacts and locations

Locations

  • Aalborg University Hospital

    Aalborg, North Denmark, 9000, Denmark

  • Aarhus University Hospital

    Aarhus, 8000, Denmark

  • Bispebjerg Hospital

    Copenhagen, 2400, Denmark

  • Gødstrup Hospital

    Herning, Central Jutland, 7400, Denmark

  • Herlev Hospital

    Herlev, Capital Region of Denmark, 2730, Denmark

  • Odense University Hospital

    Odense, The Region of Southern Denmark, 5000, Denmark

  • Regional Hospital Horsens

    Horsens, Central Jutland, 8700, Denmark

  • Regional Hospital Randers

    Randers, Central Jutland, 8930, Denmark

  • Regional Hospital Viborg

    Viborg, 8800, Denmark

  • Zealand University Hospital

    Køge, 4600, Denmark

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