Colorectal NeoplasmsRezidRASNCT07895459
MRD Monitoring in Colorectal Cancer Using ctDNA
A study testing Blood draw for ctDNA analysis in people with Colorectal Neoplasms and Colorectal Cancer (Diagnosis), run by Masaryk Memorial Cancer Institute at 1 site in Czechia.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Colorectal Cancer (Diagnosis), Minimal Residual Disease
- What is being tested?
- Blood draw for ctDNA analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 7 Feb 2023to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of colorectal cancer (clinical stage II, III, or IV).
- Presence of KRAS gene mutation (specifically G12 or G13 mutations) confirmed in the primary tumor tissue.
- Age 18 years or older at the time of inclusion.
- Patient scheduled for standard primary surgical resection, local treatment, or adjuvant therapy as per institutional guidelines.
- Signed written informed consent to participate in the study.
Who cannot join
- Absence of target KRAS mutations (G12/G13) in the primary tumor.
- Inability or unwillingness to comply with scheduled blood sampling and follow-up visits.
- Active second primary malignancy that could interfere with ctDNA interpretation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Masaryk Memorial Cancer Institute
Brno, Czech Republic, 65653
Igor Kiss, doc. MUDr. Ph.D., MBA
About this study
Official title: Monitoring of Minimal Residual Disease (MRD) in Selected Patients With Colorectal Cancer (Stages II-IV) Using Analysis of Circulating Tumor DNA (ctDNA) by the ddPCR Method
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.
Read the detailed description
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.
- Being tested
- Blood draw for ctDNA analysis
- Keywords
- ctDNA, Circulating Tumor DNA, ddPCR, Minimal Residual Disease, MRD, KRAS Mutation, Liquid Biopsy, Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms, Disease, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw for ctDNA analysisDiagnostic test
Also called Liquid Biopsy, ddPCR ctDNA Assay
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.
| Study group | Role | What they receive |
|---|---|---|
| CRC Patient Cohort | Other | Patients with colorectal cancer (stages II-IV) receiving standard care and undergoing routine blood draws for ctDNA/MRD monitoring. Receives: Diagnostic Test: Blood draw for ctDNA analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
ctDNA Detection Rate for Minimal Residual Disease Assessment
Percentage of patients with detectable circulating tumor DNA (ctDNA) in blood plasma (KRAS G12/G13 mutations assessed by ddPCR) to evaluate minimal residual disease (MRD) after primary therapy.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start7 Feb 2023
- Primary completionJan 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk Memorial Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895459
- Sponsor's protocol ID
- NI-2023/1
- Acronym
- RezidRAS
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD to be shared in pseudonymized form during the study. IPD to be published in anonymized form.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Minimal Residual Disease (MRD) in Selected Patients With Colorectal Cancer (Stages II-IV) Using Analysis of Circulating Tumor DNA (ctDNA) by the ddPCR Method
- ClinicalTrials.gov ID
- NCT07895459
- Acronym / sponsor ID
- RezidRAS / NI-2023/1
- Keywords
- ctDNA, Circulating Tumor DNA, ddPCR, Minimal Residual Disease, MRD, KRAS Mutation, Liquid Biopsy, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Masaryk Memorial Cancer InstituteUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRC Patient Cohort | Other | Diagnostic Test: Blood draw for ctDNA analysisPatients with colorectal cancer (stages II-IV) receiving standard care and undergoing routine blood draws for ctDNA/MRD monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed diagnosis of colorectal cancer (clinical stage II, III, or IV).
- Presence of KRAS gene mutation (specifically G12 or G13 mutations) confirmed in the primary tumor tissue.
- Age 18 years or older at the time of inclusion.
- Patient scheduled for standard primary surgical resection, local treatment, or adjuvant therapy as per institutional guidelines.
- Signed written informed consent to participate in the study.
Key exclusion criteria (3 listed)
- Absence of target KRAS mutations (G12/G13) in the primary tumor.
- Inability or unwillingness to comply with scheduled blood sampling and follow-up visits.
- Active second primary malignancy that could interfere with ctDNA interpretation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draw for ctDNA analysisAlso: Liquid Biopsy, ddPCR ctDNA AssayPeripheral 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. | Diagnostic test | CRC Patient Cohort |
Primary outcome
ctDNA Detection Rate for Minimal Residual Disease Assessment
Time frame: Up to 24 months
Percentage of patients with detectable circulating tumor DNA (ctDNA) in blood plasma (KRAS G12/G13 mutations assessed by ddPCR) to evaluate minimal residual disease (MRD) after primary therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD to be shared in pseudonymized form during the study. IPD to be published in anonymized form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood draw for ctDNA analysis in people with Colorectal Neoplasms and Colorectal Cancer (Diagnosis), run by Masaryk Memorial Cancer Institute at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Igor Kiss, doc. MUDr. Ph.D., MBA (+42054313111, igor.kiss@mou.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ctDNA Detection Rate for Minimal Residual Disease Assessment (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.