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Blood test may predict when colorectal cancer treatment fails

NCT ID NCT05487248

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Updated 2 times

Summary

This study looks at whether changes in tumor DNA found in the blood (ctDNA) can predict if chemotherapy is working in people with advanced colorectal cancer that no longer responds to standard treatments. About 103 participants will give blood samples and have regular scans to track their cancer. The goal is to find the best time and cutoff for ctDNA changes to signal when the cancer is progressing, which could help doctors adjust treatment sooner.

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

103 people

The number who actually took part.

Started

Oct 2023

Finished

Aug 2026

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: 1. Age ≥ 18 years old 2. Male or female 3. ECOG performance status ≤2 4. Must have histologically or cytologically verified colorectal cancer adenocarcinoma 5. Inoperable locally advanced or metastatic disease 6. Presence of measurable disease (by RECIST criteria version 1.1) on baseline CT scan of the thorax/abdomen/pelvis or CT scan of the thorax and MRI of the abdomen/pelvis 7. At least two prior systemic treatments for advanced/metastatic colorectal cancer including oxaliplatin and irinotecan-based therapy (adjuvant or neoadjuvant systemic chemotherapy will be considered if tumour progression was documented within 6 month of the last chemotherapy dose) 8. Candidate for standard third-line or subsequent lines of therapy as per decision of the treating physician 9. Life expectancy of at least 3 months 10. Women of childbearing potential must have a negative serum pregnancy test done within 28 days prior to enrolment. 11. Effective contraception is in place for women of childbearing potential. 12. Completion of all necessary screening procedures within 28 days prior to enrolment. 13. Availability of archived tumour tissue 14. Signed Informed Consent form (ICF) obtained prior to any study related procedure. Inclusion criterion applicable to FRANCE only 15. Affiliated to the French Social Security System Exclusion Criteria: 1. Tumours other than colorectal cancer 2. Histologies other than adenocarcinoma 3. Any baseline medical condition that would contraindicate the use of systemic chemotherapy or may preclude the regular administration of the same 4. Any psychiatric condition that would prohibit the understanding or rendering of informed consent 5. Other invasive malignancy within 3 years except for non-invasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured 6. Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study. 7. Pregnant and/ or lactating women Exclusion criterion applicable to FRANCE only 8. Vulnerable persons according to the article L.1121-6 of the Public Health Code, adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the Public Health Code.

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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

  • CHIREC Delta

    Brussels, Belgium

  • CHU Ambroise Pare

    Mons, 7000, Belgium

  • CHU Poitiers

    Poitiers, France

  • Centre Georges François Leclerc

    Dijon, France

  • Cliniques Universitaires Saint Luc

    Woluwe-Saint-Lambert, 1200, Belgium

  • Hopital Franco-Britannique - Fondation Cognacq-Jay

    Levallois-Perret, 92300, France

  • Hopital St-Louis

    Paris, France

  • Hopital privé Jean Mermoz

    Lyon, France

  • ICANS Strasbourg

    Strasbourg, France

  • ICO Saint-Herblain

    Saint-Herblain, France

  • Institut Jules Bordet

    Anderlecht, 1070, Belgium

  • UZ Antwerpen

    Antwerp, Belgium

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Other studies related to the condition(s) this trial covers.