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Blood test could predict cancer return after surgery

NCT ID NCT03637686

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a simple blood test can find tiny bits of cancer DNA left in the body after surgery for colorectal cancer. The goal is to identify patients at high risk of the cancer coming back, so doctors can adjust follow-up care. Over 3,000 people with stage I-III colorectal cancer are taking part. The test is not a treatment itself, but a way to better understand and monitor the disease.

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

3,182 people

The number who actually took part.

Started

Jun 2018

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.

Who is studied

All patients with stage I-III colon or rectal cancer, scheduled for curative intended resectional surgery.

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.

Part I: Surgery Inclusion Criteria: * Colon or rectal cancer, clinical tumor stage I-III * Patient able to understand and sign written informed consent * Scheduled for curative intended resectional surgery Exclusion Criteria: * Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome * Inflammatory bowel disease (Crohn's disease or ulcerative colitis) * Verified distant metastases * Malignant colorectal polyps diagnosed after polypectomy * 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 Part II: Surveillance: Inclusion criteria: One of the following: * TNM stage III CRC, * or TNM stage II CRC and risk factors qualifying for adjuvant chemotherapy, * or TNM stage I or stage II CRC without risk factors, but ctDNA positive in the post-operative day14 plasma sample. Inclusion requires that the patient declined participation in the IMPROVE IT trial. Exclusion criteria: * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Aalborg University Hospital

    Aalborg, North Denmark, 9000, Denmark

  • Aarhus University Hospital

    Aarhus, 8000, Denmark

  • Bispebjerg Hospital

    Copenhagen, 2400, Denmark

  • Herlev Hospital

    Herlev, 2730, Denmark

  • Odense University Hospital

    Odense, The Region of Southern Denmark, 5000, Denmark

  • Regional Hospital Horsens

    Horsens, 8700, Denmark

  • Regional Hospital Randers

    Randers, 8930, Denmark

  • Regional Hospital Viborg

    Viborg, 8800, Denmark

  • Regional Hospital West Jutland

    Herning, 7400, Denmark

  • Zealand University Hospital

    Køge, 4600, Denmark

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