Colorectal CancerNCT06903325
A Prospective Multicentre Clinical Study of Dynamic Monitoring of Plasma ctDNA Methylation Markers to Predict Recurrence of Colorectal Cancer After Complete Resection of Peritoneal Metastases
An observational study of Colorectal Cancer and Peritoneal Metastases, run by Fudan University at 1 site in China.
Trial summary
The goal of this clinical trial is to explore the predictive effect of postoperative plasma ctDNA methylation status on postoperative recurrence free survival (RFS) of colorectal cancer patients with peritoneal metastasis after R0/R1 resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Peritoneal Metastases
- What is being tested?
- As an observational study, we did not intervene
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 31 Oct 2027
- Phase
- Observational
- 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
Study population: Patients with peritoneal metastasis from colorectal cancer whose preoperative imaging PCI score was ≤20 and could be evaluated for R0/R1 resection were screened for enrollment. Preoperative plasma samples and tumor tissue samples were collected for ctDNA multigene methylation markers detection. Patients who achieved R0/R1 resection of peritoneal carcinomatosis were enrolled in this clinical study.
Who may be able to join
- -1. No gender limit, age greater than 18 years old; 2, ECOG score ≤1; 3. Life expectancy ≥2 years; 4. Colorectal adenocarcinoma/mucinous adenocarcinoma/signet ring cell carcinoma confirmed by histopathology; 5, preoperative PCI score ≤20, peritoneal tumor cytoreductive surgery (CRS), surgery to achieve R0/1 resection; 6. Be able to understand the situation of this study and sign the informed consent.
- 7. The primary colorectal cancer has undergone R0 resection, and there is no extraperitoneal metastasis (except ovary).
Who cannot join
- 1. Combined with primary malignant tumors of other organs (current or within the past 5 years) (excluding patients with skin basal cell carcinoma and cervical carcinoma in situ undergoing radical treatment); 2. Severe mental illness or drug abuse; 3, severe heart, lung, vascular disease can not tolerate surgery; 4. Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Weijing Zhang, 021-64175590 ext. 88503
About this study
The goal of this clinical trial is to explore the predictive effect of postoperative plasma ctDNA methylation status on postoperative recurrence free survival (RFS) of colorectal cancer patients with peritoneal metastasis after R0/R1 resection. The main questions it aims to answer are:
Preoperative and postoperative plasma ctDNA methylation detection (ColonAiQ) was performed in patients with peritoneal metastasis from colorectal cancer who underwent R0/R1 resection. Clinical information of patients was collected to explore the predictive effect of postoperative plasma ctDNA methylation status on postoperative recurrence free survival (RFS) of colorectal cancer patients with peritoneal metastasis.
Read more
Participants will:
The patients were followed up according to the normal review procedure of the hospital and the NCCN guidelines until at least 24 months after surgery. The review content included CT/MRI imaging evaluation and blood CEA (every 3 months). Whole-blood samples were obtained for timely plasma separation and ctDNA extraction at 1 month after surgery (before the start of postoperative chemotherapy) and every 3 months through 24 months after surgery. One blood sample was obtained when tumor recurrence was first detected on imaging.
Detection of methylation in tissue and plasma samples
- GutSeer methylation NGS was performed on peritoneal metastatic cancer tissues and paired normal peritoneal tissues.
- ctDNA GutSeer methylation NGS was performed on plasma samples before surgery, 1 month after surgery, 24 months after surgery, and when tumor recurrence was first detected by imaging examination.
- ctDNA methylation PCR (ColonAiQ) was performed on plasma samples before surgery, 1 month after surgery, every 3 months to 24 months after surgery, and when tumor recurrence was first detected by imaging examination.
- Conditions
- Colorectal Cancer, Peritoneal Metastases
- Being tested
- As an observational study, we did not intervene
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
As an observational study, we did not interveneOther
Interventions
| Study group | Role | What they receive |
|---|---|---|
| POM1 positive | Patients whose 1-month-postoperative plasma ctDNA methylation status is positive Receives: Other: As an observational study, we did not intervene | |
| POM1 negative | Patients whose 1-month-postoperative plasma ctDNA methylation status is negative Receives: Other: As an observational study, we did not intervene |
What is being measured
The primary outcome is the main question the study is designed to answer.
predictive value of ColonAiQ postoperative recurrence free survival (RFS)
explore the predictive effect of postoperative plasma ctDNA methylation status on postoperative recurrence free survival (RFS) of colorectal cancer patients with peritoneal metastasis.
Measured: 2023.10-2027.10
Secondary outcomes (4)
predictive value of GutSeer for RFS
Preoperative and postoperative plasma ctDNA polygene methylation test (GutSeer) was performed in patients with peritoneal metastasis from colorectal cancer who underwent R0/R1 resection, and the clinical information of patients' recurrence-free survival (RFS) was collected to explore the predictive effect of postoperative plasma ctDNA methylation status on postoperative RFS of colorectal cancer peritoneal metastasis.
Measured: 2023.10-2027.10
predictive value of ctDNA for dynamic monitoring
To explore the predictive value of plasma ctDNA methylation status before surgery, after postoperative adjuvant chemotherapy, and regularly monitored after surgery for recurrence and metastasis of colorectal cancer patients with peritoneal metastasis
Measured: 2023.10-2027.10
difference of predictive value of ColonAiQ and GutSeer
Compare the prognostic value of GutSeer and ColonAiQ and CEA at 1 month after surgery;
Measured: 2023.10-2027.10
the advance time of dynamic detection of plasma ctDNA methylation compared with imaging monitoring
To explore the advance time of dynamic detection of plasma ctDNA methylation compared with imaging monitoring in monitoring recurrence after complete resection of peritoneal metastasis from colorectal cancer
Measured: 2023.10-2027.10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 Oct 2023
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University
- Responsible party
- Principal investigator, Guoxiang Cai, Fudan University
- Investigators
- Guoxiang Cai, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903325
- Sponsor's protocol ID
- CRIP-ctDNA
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results of clinical trials will be published in the form of a paper, but content involving patient personal information or sensitive information will be kept confidential as required by the Ethics Committee
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicentre Clinical Study of Dynamic Monitoring of Plasma ctDNA Methylation Markers to Predict Recurrence of Colorectal Cancer After Complete Resection of Peritoneal Metastases
- ClinicalTrials.gov ID
- NCT06903325
- Acronym / sponsor ID
- CRIP-ctDNA
- Conditions
- Colorectal Cancer, Peritoneal Metastases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 30 Mar 2025 (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.
The goal of this clinical trial is to explore the predictive effect of postoperative plasma ctDNA methylation status on postoperative recurrence free survival (RFS) of colorectal cancer patients with peritoneal metastasis after R0/R1 resection. The main questions it aims to answer are:
Preoperative and postoperative plasma ctDNA methylation detection (ColonAiQ) was performed in patients with peritoneal metastasis from colorectal cancer who underwent R0/R1 resection. Clinical information of patients was collected to explore the predictive effect of postoperative plasma ctDNA methylation status on postoperative recurrence free survival (RFS) of colorectal cancer patients with peritoneal metastasis.
Participants will:
The patients were followed up according to the normal review procedure of the hospital and the NCCN guidelines until at least 24 months after surgery. The review content included CT/MRI imaging evaluation and blood CEA (every 3 months). Whole-blood samples were obtained for timely plasma separation and ctDNA extraction at 1 month after surgery (before the start of postoperative chemotherapy) and every 3 months through 24 months after surgery. One blood sample was obtained when tumor recurrence was first detected on imaging.
Detection of methylation in tissue and plasma samples
- GutSeer methylation NGS was performed on peritoneal metastatic cancer tissues and paired normal peritoneal tissues.
- ctDNA GutSeer methylation NGS was performed on plasma samples before surgery, 1 month after surgery, 24 months after surgery, and when tumor recurrence was first detected by imaging examination.
- ctDNA methylation PCR (ColonAiQ) was performed on plasma samples before surgery, 1 month after surgery, every 3 months to 24 months after surgery, and when tumor recurrence was first detected by imaging examination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POM1 positive | – | Other: As an observational study, we did not intervenePatients whose 1-month-postoperative plasma ctDNA methylation status is positive |
| POM1 negative | – | Other: As an observational study, we did not intervenePatients whose 1-month-postoperative plasma ctDNA methylation status is negative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with peritoneal metastasis from colorectal cancer whose preoperative imaging PCI score was ≤20 and could be evaluated for R0/R1 resection were screened for enrollment. Preoperative plasma samples and tumor tissue samples were collected for ctDNA multigene methylation markers detection. Patients who achieved R0/R1 resection of peritoneal carcinomatosis were enrolled in this clinical study.
Key inclusion criteria (2 listed)
- -1. No gender limit, age greater than 18 years old; 2, ECOG score ≤1; 3. Life expectancy ≥2 years; 4. Colorectal adenocarcinoma/mucinous adenocarcinoma/signet ring cell carcinoma confirmed by histopathology; 5, preoperative PCI score ≤20, peritoneal tumor cytoreductive surgery (CRS), surgery to achieve R0/1 resection; 6. Be able to understand the situation of this study and sign the informed consent.
- 7. The primary colorectal cancer has undergone R0 resection, and there is no extraperitoneal metastasis (except ovary).
Key exclusion criteria (1 listed)
- 1. Combined with primary malignant tumors of other organs (current or within the past 5 years) (excluding patients with skin basal cell carcinoma and cervical carcinoma in situ undergoing radical treatment); 2. Severe mental illness or drug abuse; 3, severe heart, lung, vascular disease can not tolerate surgery; 4. Pregnant or lactating women.
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 |
|---|---|---|
| As an observational study, we did not interveneInterventions | Other | POM1 negative, POM1 positive |
Primary outcome
predictive value of ColonAiQ postoperative recurrence free survival (RFS)
Time frame: 2023.10-2027.10
explore the predictive effect of postoperative plasma ctDNA methylation status on postoperative recurrence free survival (RFS) of colorectal cancer patients with peritoneal metastasis.
4 secondary outcomes
predictive value of GutSeer for RFS
Time frame: 2023.10-2027.10
predictive value of ctDNA for dynamic monitoring
Time frame: 2023.10-2027.10
difference of predictive value of ColonAiQ and GutSeer
Time frame: 2023.10-2027.10
the advance time of dynamic detection of plasma ctDNA methylation compared with imaging monitoring
Time frame: 2023.10-2027.10
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 30 Mar 2025.
- Individual participant dataSharing planned: No. The results of clinical trials will be published in the form of a paper, but content involving patient personal information or sensitive information will be kept confidential as required by the Ethics Committee
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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.
Guoxiang Cai principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Peritoneal Metastases, run by Fudan University at 1 site in China.
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 2 inclusion and 1 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 30 Mar 2025. 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 China. 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 Guoxiang Cai, MD, PhD (+86-18819431363, hanlingyu_ann@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predictive value of ColonAiQ postoperative recurrence free survival (RFS) (time frame: 2023.10-2027.10). 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 30 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.