An interventional study of Blood draw for ctDNA analysis in Colorectal Neoplasms, Colorectal Cancer (Diagnosis) and Minimal Residual Disease, sponsored by Masaryk Memorial Cancer Institute. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Masaryk Memorial Cancer Institute · Not applicable, Interventional, and Diagnostic
This clinical study evaluates the use of free circulating tumor DNA (ctDNA) analysis from peripheral blood, known as liquid biopsy. The objective is to detect minimal residual disease (MRD) early and to predict disease relapse or progression in patients with colorectal cancer (stages II-IV). By monitoring specific KRAS gene mutations (G12 and G13) using the ddPCR method, the study aims to improve risk stratification and treatment response monitoring following primary therapy.
This prospective study evaluates the use of free circulating tumor DNA (ctDNA) as a molecular biomarker for monitoring minimal residual disease (MRD) in patients with colorectal cancer (CRC) stages II through IV.
The objective of the project is to validate the ddPCR method for detecting specific KRAS gene mutations (G12 and G13) from patient blood samples. For patients with stage II and III CRC, plasma samples are collected at least 2 weeks after surgery prior to adjuvant therapy or follow-up, and subsequently at regular 3-month intervals for a duration of 2 years. For patients with clinical stage IV disease, blood samples are collected before resection or local treatment of metastatic disease, at least 2 weeks after the procedure, and thereafter at 3-month intervals for 2 years. The primary intent is the early detection of recurrence and improved patient risk stratification.
5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's planned enrollment of 60 is below the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Masaryk Memorial Cancer Institute is the lead sponsor of 13 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Patients with colorectal cancer (stages II-IV) receiving standard care and undergoing routine blood draws for ctDNA/MRD monitoring.
Diagnostic Test: Blood draw for ctDNA analysis
Peripheral blood sampling for ctDNA isolation and subsequent KRAS mutation detection (G12, G13) via ddPCR. This is an observational procedure for MRD monitoring and not a therapeutic intervention.
Also known as: Liquid Biopsy, ddPCR ctDNA Assay
ctDNA Detection Rate and Correlation with Minimal Residual Disease (MRD)
Evaluation of free circulating tumor DNA (ctDNA) presence in blood plasma by detecting KRAS gene mutations (G12/G13) using digital droplet PCR (ddPCR) to assess minimal residual disease after primary therapy.
Time frame: Up to 2 years (samples collected post-surgery/treatment and every 3 months during follow-up).
Plan to share: Yes — IPD to be shared in pseudonymized form during the study. IPD to be published in anonymized form.
Supporting information: Clinical study report
Time frame: after study completion
Access criteria: During the study, data will be managed in pseudonymized form in a protected database environment, available only for study team.After completion of the study, the data will be fully anonymized for publication purposes. All publication outputs of the study will be carried out by a team of researchers led by the principal investigator. The submission of each publication is subject to the approval of the principal investigator.The results of this study may be published or presented at scientific meetings after approval by the PI and always after anonymization of the subjects' personal data in accordance with Act No. 101/2000 Coll., on the protection of personal data.
Data sharing details ↗ · www.mou.cz
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Masaryk Memorial Cancer Institute