Clinical trial · Observational
Analysis of Circulating Tumor DNA to Monitor Metastatic Colorectal Cancer Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Colorectal cancer (CRC) is the third of the most common cancers and the second leading cause of cancer death in western countries. CRC is diagnosed at metastatic stage in approximately 35% of cases, while about 20% to 50% of patients diagnosed at earlier stage (stage II and III) will develop distant metastasis subsequently. Treatment efficacy is usually evaluated by computer tomography (CT) scan with RECIST criteria and dosage of carcinoembryonic antigen (CEA) and carbohydrate antigen (CA) 19-9, which were performed every two weeks during the chemotherapy. The management of treatment for metastatic CRC need the development of early biomarkers to evaluate the efficacy in order to avoid unnecessary toxicity in case of early chemotherapy resistance. In this prospective study, the investigators will compare the monitoring of circulating tumor DNA with the results of CT scan according the RECIST criteria and the blood level of CEA and CA 19-9. The investigators carried out a microfluidic digital polymerase-chain-reaction (PCR) assay to measure the specific somatic genomic alterations in plasma to identify the circulating tumor DNA.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| To Compare the Monitoring of Circulating Tumor DNA With the Efficacy of Chemotherapy Evaluated by Computer Tomography Scan. | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- To compare the monitoring of circulating tumor DNA with the results of computer tomography scan according the RECIST criteria
- timeFrame
- From first biomarker date to first clinical event
- measure
- To compare the monitoring of circulating tumor DNA with the response tumor evaluated by RECIST criteria on computer tomography scan
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 ans, * histologically proven metastatic colorectal adenocarcinoma, * at least one measurable lesion (RECIST criteria), * strating a new line of chemotherapy including fluoropyrimidin and/or oxaliplatin and/or irinotecan with or without targeted therapy(EGFR-targeted therapy or antiangiogenic), and written informed consent. Exclusion Criteria: * Patient unable to read or understand and sign the information sheet and consent form * Patient not insured under the social security
References
Publications (1)
- DERIVEDUnseld M, Belic J, Pierer K, Zhou Q, Moser T, Bauer R, Piringer G, Gerger A, Siebenhuner A, Speicher M, Heitzer E, Prager GW. A higher ctDNA fraction decreases survival in regorafenib-treated metastatic colorectal cancer patients. Results from the regorafenib's liquid biopsy translational biomarker phase II pilot study. Int J Cancer. 2021 Mar 15;148(6):1452-1461. doi: 10.1002/ijc.33303. Epub 2020 Oct 16. PMID 32949150