Non-metastatic Colorectal CancerNCT05904665
Circulating Tumor DNA Methylation Guided Postoperative Follow-up Strategy for Non-metastatic Colorectal Cancer
A study testing ctDNA methylation dynamic monitoring in people with Non-metastatic Colorectal Cancer and Circulating Tumor DNA Methylation, run by Fudan University at 1 site in China.
Trial summary
Colorectal cancer (CRC) is one of the most common gastrointestinal tumors. According to the latest cancer report, the incidence and mortality rates of CRC are both ranked top 5 among malignant tumors worldwide and continue to rise. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-metastatic Colorectal Cancer, Circulating Tumor DNA Methylation
- What is being tested?
- ctDNA methylation dynamic monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 584 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2023to Jun 2028
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, regardless of gender;
- Personal status (PS) score as over 80 or Eastern Cooperative Oncology Group (ECOG) score as 0 ~ 2;
- Preoperative imaging examinations reveal no definite distant metastatic lesions, and postoperative pTNM staging confirms patients with stage I to III colorectal cancer;
- Radical operation performed ;
- With expected survival of more than 12 months;
- The subjects (or their legal representative / Guardian) must sign the informed consent form, indicating that they understand the purpose of the study, understand the necessary procedures of the study, and are willing to participate in the study.
Who cannot join
- Blood transfusion performed during operation or within 2 weeks before operation;
- Incomplete baseline samples, including preoperative plasma samples;
- Two consecutive test points missing or three plasma samples missing in total before a positive ctDNA time point;
- Pregnant or lactating women who have fertility and do not take adequate contraceptive measures;
- Have a history of other malignant tumors within 5 years, except cured cervical carcinoma in situ or non melanoma skin cancer;
- Primary brain tumor or central nerve metastasis is not under control, with obvious intracranial hypertension or neuropsychiatric symptoms;
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- Patients with the following serious or uncontrollable diseases: severe heart disease, the condition is still unstable after treatment, including myocardial infarction, congestive heart failure, unstable angina pectoris, pericardial effusion with obvious symptoms or unstable arrhythmia within 6 months before enrollment; definite neuropathy or psychosis, including dementia or seizures; severe or uncontrolled infection; active disseminated intravascular coagulation and obvious bleeding tendency;
- Significant impairment of important organ function;
- Other conditions in which the investigator believes that the patient should not participate in this trial.
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
Junjie Peng, MD, PhD, 86-18017317122, pengjj67@hotmail.com
Shaobo Mo, MD, PhD, 86-18121290562, shaobom@126.com
About this study
Official title: Circulating Tumor DNA Methylation Guided Postoperative Follow-up Strategy for Non-metastatic Colorectal Cancer: a Multicenter, Prospective, Randomized Controlled Cohort Study (FIND Trial)
Colorectal cancer (CRC) is one of the most common gastrointestinal tumors. According to the latest cancer report, the incidence and mortality rates of CRC are both ranked top 5 among malignant tumors worldwide and continue to rise. Patients who receive treatment in the early stage (stage I) have a 5-year survival rate of approximately 90%. However, for high-risk stage II and III colorectal cancer patients, the 5-year survival rate is only 40%-70%, and almost half of the patients experience postoperative recurrence and metastasis.
Circulating tumor DNA (ctDNA) is a small fraction of total cell-free DNA (cfDNA) in peripheral blood circulation, carrying tumor-specific genetic and epigenetic information. It can usually be detected in the serum or plasma of tumor patients in peripheral blood. Studies have shown that methylation detection of plasma ctDNA can be used for predicting the efficacy and prognosis of tumor postoperatively, as well as for dynamic monitoring.
Read more
Current methods for monitoring CRC recurrence include testing for carcinoembryonic antigen (CEA) in blood and periodic computed tomography (CT) scans. However, due to the low sensitivity of CEA and the radiation and cost limitations of CT examination, the disease status of postoperative CRC patients cannot be well-monitored.
ctDNA is a promising biomarker for monitoring the recurrence and metastasis of CRC. Research results have shown that ctDNA can be detected in nearly all subjects before surgery, and the changes in ctDNA levels are related to the extent of surgical resection. The detection of ctDNA after surgery generally indicates recurrence within one year. ctDNA may be a more reliable and sensitive indicator than the current standard biomarker CEA, providing a window for early intervention.
This multicenter, prospective, and randomized controlled cohort study uses a single-tube methylation-specific quantitative PCR (mqMSP) detection, which detects 10 different methylation markers and can quantitatively analyze plasma samples containing tumor DNA as low as 0.01%. This study will use the ctDNA methylation detection technology to conduct quantitative detection of ctDNA methylation in the plasma of enrolled patients, hoping to predict the recurrence and metastasis risk of patients at an earlier stage through ctDNA changes, and to explore the value of ctDNA detection in guiding postoperative follow-up for non-metastatic CRC.
- Being tested
- ctDNA methylation dynamic monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ctDNA methylation dynamic monitoringDiagnostic test
ctDNA methylation detection is performed within one month before surgery, within one month after surgery, and every three months after surgery, for a period of 2 years.
| Study group | Role | What they receive |
|---|---|---|
| ctDNA dynamic monitoring + routine postoperative follow-up | Experimental | Dynamic monitoring of ctDNA + routine postoperative follow-up: ctDNA detection is performed within one month before surgery, within one month after surgery, and every three months after surgery, for a period of 2 years. At the same time, routine postoperative follow-up is given.
Follow-up intervention*: After completion of adjuvant chemotherapy in the patient, if ctDNA detection suggests positive, immediate chest, abdomen, and pelvis CT and other imaging examinations are performed to determine whether there is recurrence or metastasis. If it is not confirmed, repeat imaging examinations are carried out every two months in the follow-up process, and ctDNA detection is continued every three months according to the schedule. If two consecutive ctDNA retests are negative, the above imaging follow-up will resume at the frequency of routine follow-up. Receives: Diagnostic Test: ctDNA methylation dynamic monitoring |
| Routine postoperative follow-up | No intervention | Routine postoperative follow-up: Only routine postoperative follow-up is given as follows: Physical examination and CEA were performed every 3-6 months for the first 2 years, every 6 months within the third to fifth year, and then annually. Chest/abdominal/pelvis computed tomography was performed annually for up to 5 years, and colonoscopy was performed for proper patients the first year after treatment and repeated in the third year if no advanced adenoma was found and then every 5 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary curative-intent rate
This study primarily evaluates whether ctDNA-informed surveillance after surgery increases the proportion of patients with CRC recurrence who receive curative-intent or metastasis-directed therapy, compared to the standard follow-up protocol within 2 years of initial surgery.
Measured: Up to 24 months
Secondary outcomes (10)
TTCR
To exam whether ctDNA-guided surveillance leads to a reduced time to clinical recurrence (TTCR) compared to standard surveillance.
Measured: Up to 60 months
DFS
To investigate ctDNA-based disease-free survival (ctDNA-DFS), CT-based disease-free survival (CT-DFS), and the difference between ctDNA-DFS and CT-DFS (△-DFS).
Measured: Up to 60 months
Sensitivity of postoperative ctDNA monitoring for detecting recurrence
To investigate sensitivity of postoperative ctDNA monitoring for detecting recurrence (Sensitivity=Number of ctDNA-positive patients confirmed with recurrence by imaging/Total number of patients confirmed with recurrence by imaging).
Measured: Up to 60 months
Specificity of postoperative ctDNA monitoring for detecting recurrence
To investigate specificity of postoperative ctDNA monitoring for detecting recurrence (Specificity= Number of ctDNA-negative patients confirmed without recurrence by imaging /Total number of patients confirmed without recurrence by imaging).
Measured: Up to 60 months
OS
To exam whether 3- and 5-year overall survival (OS) with ctDNA-guided surveillance is comparable to that achieved with standard CT-based monitoring.
Measured: Up to 60 months
Patient-reported outcomes (quality of life)
To assess patient-reported outcomes-quality of life (EORTC QLQ-C30)-in those receiving ctDNA-guided versus standard surveillance.
Measured: Up to 60 months
Patient-reported outcomes (fear of cancer recurrence)
To assess patient-reported outcomes-fear of cancer recurrence (FCRI)-in those receiving ctDNA-guided versus standard surveillance.
Measured: Up to 60 months
Patient-reported outcomes (cancer-related distress)
To assess patient-reported outcomes-cancer-related distress (IES-C)-in those receiving ctDNA-guided versus standard surveillance.
Measured: Up to 60 months
Patient-reported outcomes [emotional distress (PHQ-9 scales)]
To assess patient-reported outcomes-emotional distress (PHQ-9 scales)-in those receiving ctDNA-guided versus standard surveillance.
Measured: Up to 60 months
Patient-reported outcomes [emotional distress (GAD-7 scales)]
To assess patient-reported outcomes-emotional distress (GAD-7 scales)-in those receiving ctDNA-guided versus standard surveillance.
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start15 Jun 2023
- Primary completion15 Jul 2025
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-metastatic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 584 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junjie Peng, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904665
- Sponsor's protocol ID
- FIND Trial
- Status last verified
- Sep 2025
- First submitted
- 6 Jun 2023
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mo S, Zhou C, Ma M, Luo W, Li Y, Lu P, Tang P, Li Y, Ma X, Hu X, Cheng C, Yang J, Zhuo C, Jian J, Yu C, Ding J, Xiong C, Jiang F, Mu R, Lu Z, Yu J, Jin S, Luan J, Li X, Cai S, Zou H, Li Y, Li Q, Liu F, Ding C, Peng J. Dynamic Circulating Tumor DNA Methylation Monitoring Guiding Postoperative Surveillance in Nonmetastatic Colorectal Cancer: A Prospective, Randomized, Phase III FIND Trial. J Clin Oncol. 2026 Jul 29:JCO2503009. doi: 10.1200/JCO-25-03009. Online ahead of print.
PubMed 42525894
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA Methylation Guided Postoperative Follow-up Strategy for Non-metastatic Colorectal Cancer: a Multicenter, Prospective, Randomized Controlled Cohort Study (FIND Trial)
- ClinicalTrials.gov ID
- NCT05904665
- Acronym / sponsor ID
- FIND Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 584 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- Jun 2028 (estimated)
- First posted
- 15 Jun 2023 (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.
Colorectal cancer (CRC) is one of the most common gastrointestinal tumors. According to the latest cancer report, the incidence and mortality rates of CRC are both ranked top 5 among malignant tumors worldwide and continue to rise. Patients who receive treatment in the early stage (stage I) have a 5-year survival rate of approximately 90%. However, for high-risk stage II and III colorectal cancer patients, the 5-year survival rate is only 40%-70%, and almost half of the patients experience postoperative recurrence and metastasis.
Circulating tumor DNA (ctDNA) is a small fraction of total cell-free DNA (cfDNA) in peripheral blood circulation, carrying tumor-specific genetic and epigenetic information. It can usually be detected in the serum or plasma of tumor patients in peripheral blood. Studies have shown that methylation detection of plasma ctDNA can be used for predicting the efficacy and prognosis of tumor postoperatively, as well as for dynamic monitoring.
Current methods for monitoring CRC recurrence include testing for carcinoembryonic antigen (CEA) in blood and periodic computed tomography (CT) scans. However, due to the low sensitivity of CEA and the radiation and cost limitations of CT examination, the disease status of postoperative CRC patients cannot be well-monitored.
ctDNA is a promising biomarker for monitoring the recurrence and metastasis of CRC. Research results have shown that ctDNA can be detected in nearly all subjects before surgery, and the changes in ctDNA levels are related to the extent of surgical resection. The detection of ctDNA after surgery generally indicates recurrence within one year. ctDNA may be a more reliable and sensitive indicator than the current standard biomarker CEA, providing a window for early intervention.
This multicenter, prospective, and randomized controlled cohort study uses a single-tube methylation-specific quantitative PCR (mqMSP) detection, which detects 10 different methylation markers and can quantitatively analyze plasma samples containing tumor DNA as low as 0.01%. This study will use the ctDNA methylation detection technology to conduct quantitative detection of ctDNA methylation in the plasma of enrolled patients, hoping to predict the recurrence and metastasis risk of patients at an earlier stage through ctDNA changes, and to explore the value of ctDNA detection in guiding postoperative follow-up for non-metastatic CRC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ctDNA dynamic monitoring + routine postoperative follow-up | Experimental | Diagnostic Test: ctDNA methylation dynamic monitoringDynamic monitoring of ctDNA + routine postoperative follow-up: ctDNA detection is performed within one month before surgery, within one month after surgery, and every three months after surgery, for a period of 2 years. At the same time, routine postoperative follow-up is given. Follow-up intervention*: After completion of adjuvant chemotherapy in the patient, if ctDNA detection suggests positive, immediate chest, abdomen, and pelvis CT and other imaging examinations are performed to determine whether there is recurrence or metastasis. If it is not confirmed, repeat imaging examinations are carried out every two months in the follow-up process, and ctDNA detection is continued every three months according to the schedule. If two consecutive ctDNA retests are negative, the above imaging follow-up will resume at the frequency of routine follow-up. |
| Routine postoperative follow-up | No intervention | –Routine postoperative follow-up: Only routine postoperative follow-up is given as follows: Physical examination and CEA were performed every 3-6 months for the first 2 years, every 6 months within the third to fifth year, and then annually. Chest/abdominal/pelvis computed tomography was performed annually for up to 5 years, and colonoscopy was performed for proper patients the first year after treatment and repeated in the third year if no advanced adenoma was found and then every 5 years. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years old, regardless of gender;
- Personal status (PS) score as over 80 or Eastern Cooperative Oncology Group (ECOG) score as 0 ~ 2;
- Preoperative imaging examinations reveal no definite distant metastatic lesions, and postoperative pTNM staging confirms patients with stage I to III colorectal cancer;
- Radical operation performed ;
- With expected survival of more than 12 months;
Key exclusion criteria (9 listed)
- Blood transfusion performed during operation or within 2 weeks before operation;
- Incomplete baseline samples, including preoperative plasma samples;
- Two consecutive test points missing or three plasma samples missing in total before a positive ctDNA time point;
- Pregnant or lactating women who have fertility and do not take adequate contraceptive measures;
- Have a history of other malignant tumors within 5 years, except cured cervical carcinoma in situ or non melanoma skin cancer;
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 |
|---|---|---|
| ctDNA methylation dynamic monitoringctDNA methylation detection is performed within one month before surgery, within one month after surgery, and every three months after surgery, for a period of 2 years. | Diagnostic test | ctDNA dynamic monitoring + routine postoperative follow-up |
Primary outcome
Secondary curative-intent rate
Time frame: Up to 24 months
This study primarily evaluates whether ctDNA-informed surveillance after surgery increases the proportion of patients with CRC recurrence who receive curative-intent or metastasis-directed therapy, compared to the standard follow-up protocol within 2 years of initial surgery.
10 secondary outcomes
TTCR
Time frame: Up to 60 months
DFS
Time frame: Up to 60 months
Sensitivity of postoperative ctDNA monitoring for detecting recurrence
Time frame: Up to 60 months
Specificity of postoperative ctDNA monitoring for detecting recurrence
Time frame: Up to 60 months
OS
Time frame: Up to 60 months
Patient-reported outcomes (quality of life)
Time frame: Up to 60 months
Patient-reported outcomes (fear of cancer recurrence)
Time frame: Up to 60 months
Patient-reported outcomes (cancer-related distress)
Time frame: Up to 60 months
Patient-reported outcomes [emotional distress (PHQ-9 scales)]
Time frame: Up to 60 months
Patient-reported outcomes [emotional distress (GAD-7 scales)]
Time frame: Up to 60 months
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 18 Sep 2025.
- Derived from this study: PubMed 42525894Mo S, Zhou C, Ma M, Luo W, Li Y, Lu P, Tang P, Li Y, Ma X, Hu X, Cheng C, Yang J, Zhuo C, Jian J, Yu C, Ding J, Xiong C, Jiang F, Mu R, Lu Z, Yu J, Jin S, Luan J, Li X, Cai S, Zou H, Li Y, Li Q, Liu F, Ding C, Peng J. Dynamic Circulating Tumor DNA Methylation Monitoring Guiding Postoperative Surveillance in Nonmetastatic Colorectal Cancer: A Prospective, Randomized, Phase III FIND Trial. J Clin Oncol. 2026 Jul 29:JCO2503009. doi: 10.1200/JCO-25-03009. Online ahead of print.
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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 ctDNA methylation dynamic monitoring in people with Non-metastatic Colorectal Cancer and Circulating Tumor DNA Methylation, 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 6 inclusion and 9 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 18 Sep 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Secondary curative-intent rate (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?
On the ClinicalTrials.gov record for NCT05904665, which also lists 1 linked publication.
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 18 Sep 2025.