Blood test may predict when colorectal cancer treatment fails
NCT ID NCT05487248
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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103 people
The number who actually took part.
- Started
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Oct 2023
- Finished
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Aug 2026
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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CHIREC Delta
Brussels, Belgium
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CHU Ambroise Pare
Mons, 7000, Belgium
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CHU Poitiers
Poitiers, France
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Centre Georges François Leclerc
Dijon, France
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Cliniques Universitaires Saint Luc
Woluwe-Saint-Lambert, 1200, Belgium
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Hopital Franco-Britannique - Fondation Cognacq-Jay
Levallois-Perret, 92300, France
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Hopital St-Louis
Paris, France
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Hopital privé Jean Mermoz
Lyon, France
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ICANS Strasbourg
Strasbourg, France
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ICO Saint-Herblain
Saint-Herblain, France
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Institut Jules Bordet
Anderlecht, 1070, Belgium
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UZ Antwerpen
Antwerp, Belgium
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a targeted drug boost chemotherapy in advanced colorectal cancer?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Two-Step PET scan aims to spot hidden colorectal cancer spread
- Can a targeted drug conjugate outsmart advanced colorectal cancer?
- Can an antimalarial drug boost immunotherapy against colorectal cancer?