Colorectal Cancer (CRC)SURIIINCT06879899
MRD-Guided Surveillance in Locally Advanced Mid-Low Rectal Cancer (SURVEILLANCE-III)
An observational study of Colorectal Cancer (CRC), run by Fudan University.
Trial summary
This study aims to explore the relationship between minimal residual disease (MRD) status and disease recurrence in patients with locally advanced mid-low rectal cancer. MRD refers to the presence of cancer cells that remain in the body after treatment but are undetectable by traditional imaging methods. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer (CRC)
- How many people
- 139 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 31 Jul 2029
- How long will I take part?
- 3 Years
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients diagnosed with locally advanced mid-low rectal cancer (cT3/N+, M0, tumor ≤10 cm from the anal verge) who have not received prior treatment. Participants will be recruited from multiple clinical centers and must meet specific eligibility criteria to ensure the study's validity. Key Characteristics of the Study Population: Diagnosis: Histologically confirmed rectal adenocarcinoma (including adenocarcinoma, mucinous adenocarcinoma, signet-ring cell carcinoma, and undifferentiated carcinoma; excluding adenosquamous carcinoma). Stage: Clinical locally advanced mid-low rectal cancer (cT3/N+, M0) confirmed by preoperative imaging and clinical assessment. Treatment History: No prior chemotherapy, radiotherapy, targeted therapy, or other anti-cancer treatments. Surgical Eligibility: Candidates must be eligible for curative-intent surgery following neoadjuvant therapy. General Health Status: ECOG performance status 0-1, indicating good functional status
Who may be able to join
- 1） Age 18-80 years old, male or female; 2) histologically confirmed diagnosis of rectal adenocarcinoma (i.e., adenoepithelial carcinoma, including adenocarcinoma, mucinous carcinoma, imprinted cell carcinoma, and undifferentiated carcinoma; excluding adenosquamous carcinoma); 3) Preoperative clinical stage cT3 /N+, M0, the lower edge of the tumor is ≤10cm from the anal verge, and no surgical resection is performed; (4) Not receiving chemotherapy, radiotherapy, targeted therapy or other anti-tumor therapy; 5) Radical surgery is available; 6) ECOG score 0-1; 7) Subjects voluntarily enrolled in this study and signed the informed consent, good compliance, follow the planned schedule and actively cooperate with the return to the hospital for regular clinical follow-up and necessary treatment.
Who cannot join
- previous other malignant tumors (including non-adenocarcinoma colorectal cancer);
- Previously received other anti-tumor therapy;
- Pregnant and lactating women; (4) Patients with other medical conditions that, in the judgment of the investigator, may interfere with follow-up and short-term survival;
- 5) Subjects have other factors that may lead to forced termination of this study, such as other serious illnesses (including mental illness, infectious diseases, fever ≥38℃, etc.) that require combined treatment, serious laboratory test abnormalities, accompanied by family or social factors that will affect the safety of the subjects, or the collection of data and samples.
About this study
This study aims to explore the relationship between minimal residual disease (MRD) status and disease recurrence in patients with locally advanced mid-low rectal cancer. MRD refers to the presence of cancer cells that remain in the body after treatment but are undetectable by traditional imaging methods. The study will use a blood-based circulating tumor DNA (ctDNA) methylation test to assess its ability to predict cancer recurrence and survival outcomes.
Patients who are newly diagnosed with cT3/N+, M0 mid-low rectal cancer (tumor ≤10 cm from the anal verge) and are eligible for curative-intent treatment will be enrolled. Blood samples will be collected at multiple time points, including before neoadjuvant therapy, before surgery, after surgery, and during follow-up visits over three years. The study will compare MRD status with disease-free survival (DFS), recurrence-free survival (RFS), overall survival (OS), and the time it takes for MRD to detect recurrence compared to standard imaging methods.
The goal is to determine whether MRD monitoring can provide an early warning of cancer recurrence and help guide treatment decisions. This study may offer valuable insights into improving postoperative surveillance and personalized treatment strategies for rectal cancer patients.
Read the detailed description
This is a multicenter, prospective, observational study designed to evaluate the effectiveness of ctDNA-based MRD monitoring in predicting disease recurrence and survival outcomes in patients with locally advanced mid-low rectal cancer. The study will enroll 139 patients who have not previously received chemotherapy, radiotherapy, or targeted therapy.
Key Objectives
Primary Objective:
To explore the correlation between MRD status and disease-free survival (DFS) in locally advanced mid-low rectal cancer patients.
Secondary Objectives:
To assess the relationship between MRD status and 1-year/2-year recurrence-free survival (1yRFS, 2yRFS).
To evaluate the association between MRD status and overall survival (OS).
Exploratory Objectives:
To determine the average time by which MRD detection precedes imaging-based detection of disease recurrence.
To assess the correlation between post-neoadjuvant therapy MRD status and pathological complete response (pCR).
Study Design
Patients will undergo blood sampling at key time points:
Baseline (pre-neoadjuvant therapy) Pre-surgery (0-7 days before surgery) Post-surgery (7±2 days after surgery) Follow-up visits at 1, 3, 6, 9, 12, 18, 24, and 36 months post-surgery MRD status will be assessed using a ctDNA methylation-based PCR test, which provides a rapid, cost-effective alternative to traditional NGS-based methods.
Statistical Analysis Kaplan-Meier survival analysis will be used to estimate DFS, RFS, and OS. Cox proportional hazards models will assess whether MRD status serves as an independent prognostic factor for recurrence.
Multivariate analysis will adjust for clinical variables, including tumor burden and treatment history.
Ethical Considerations The study adheres to the principles of the Declaration of Helsinki and Chinese Good Clinical Practice (GCP) guidelines.
Informed consent will be obtained from all participants, and privacy and confidentiality will be strictly maintained.
Expected Outcomes This study aims to validate the clinical utility of ctDNA-based MRD monitoring in predicting recurrence and survival outcomes for locally advanced mid-low rectal cancer patients. If successful, MRD testing may offer a more effective tool for postoperative surveillance and treatment planning, allowing for earlier interventions and improved long-term outcomes.
- Conditions
- Colorectal Cancer (CRC)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MRD-Guided Surveillance in Locally Advanced Mid-Low Rectal Cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploring the correlation between MRD status and disease-free survival (DFS) in patients with locally progressive low and intermediate rectal cancer
Exploring the correlation between MRD status and disease-free survival (DFS) in patients with locally progressive low and intermediate rectal cancer
Measured: From surgery to disease recurrence or up to 36 months
Secondary outcomes (3)
Correlation of MRD status with 1-year recurrence-free survival (1yRFS)
Correlation of MRD status with 1-year recurrence-free survival (1yRFS)
Measured: From surgery to 12 months
Correlation of MRD status with 2-year event-free survival (2yRFS)
Correlation of MRD status with 2-year event-free survival (2yRFS)
Measured: From surgery to 24 months
Correlation of MRD status with overall survival (OS)
Correlation of MRD status with overall survival (OS)
Measured: From surgery to death or up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies 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
- 139 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879899
- Sponsor's protocol ID
- SURVEILLANCE-III
- Acronym
- SURIII
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRD-Guided Surveillance in Locally Advanced Mid-Low Rectal Cancer (SURVEILLANCE-III)
- ClinicalTrials.gov ID
- NCT06879899
- Acronym / sponsor ID
- SURIII / SURVEILLANCE-III
- Conditions
- Colorectal Cancer (CRC)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 17 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.
This study aims to explore the relationship between minimal residual disease (MRD) status and disease recurrence in patients with locally advanced mid-low rectal cancer. MRD refers to the presence of cancer cells that remain in the body after treatment but are undetectable by traditional imaging methods. The study will use a blood-based circulating tumor DNA (ctDNA) methylation test to assess its ability to predict cancer recurrence and survival outcomes.
Patients who are newly diagnosed with cT3/N+, M0 mid-low rectal cancer (tumor ≤10 cm from the anal verge) and are eligible for curative-intent treatment will be enrolled. Blood samples will be collected at multiple time points, including before neoadjuvant therapy, before surgery, after surgery, and during follow-up visits over three years. The study will compare MRD status with disease-free survival (DFS), recurrence-free survival (RFS), overall survival (OS), and the time it takes for MRD to detect recurrence compared to standard imaging methods.
The goal is to determine whether MRD monitoring can provide an early warning of cancer recurrence and help guide treatment decisions. This study may offer valuable insights into improving postoperative surveillance and personalized treatment strategies for rectal cancer patients.
Detailed description
This is a multicenter, prospective, observational study designed to evaluate the effectiveness of ctDNA-based MRD monitoring in predicting disease recurrence and survival outcomes in patients with locally advanced mid-low rectal cancer. The study will enroll 139 patients who have not previously received chemotherapy, radiotherapy, or targeted therapy.
Key Objectives
Primary Objective:
To explore the correlation between MRD status and disease-free survival (DFS) in locally advanced mid-low rectal cancer patients.
Secondary Objectives:
To assess the relationship between MRD status and 1-year/2-year recurrence-free survival (1yRFS, 2yRFS).
To evaluate the association between MRD status and overall survival (OS).
Exploratory Objectives:
To determine the average time by which MRD detection precedes imaging-based detection of disease recurrence.
To assess the correlation between post-neoadjuvant therapy MRD status and pathological complete response (pCR).
Study Design
Patients will undergo blood sampling at key time points:
Baseline (pre-neoadjuvant therapy) Pre-surgery (0-7 days before surgery) Post-surgery (7±2 days after surgery) Follow-up visits at 1, 3, 6, 9, 12, 18, 24, and 36 months post-surgery MRD status will be assessed using a ctDNA methylation-based PCR test, which provides a rapid, cost-effective alternative to traditional NGS-based methods.
Statistical Analysis Kaplan-Meier survival analysis will be used to estimate DFS, RFS, and OS. Cox proportional hazards models will assess whether MRD status serves as an independent prognostic factor for recurrence.
Multivariate analysis will adjust for clinical variables, including tumor burden and treatment history.
Ethical Considerations The study adheres to the principles of the Declaration of Helsinki and Chinese Good Clinical Practice (GCP) guidelines.
Informed consent will be obtained from all participants, and privacy and confidentiality will be strictly maintained.
Expected Outcomes This study aims to validate the clinical utility of ctDNA-based MRD monitoring in predicting recurrence and survival outcomes for locally advanced mid-low rectal cancer patients. If successful, MRD testing may offer a more effective tool for postoperative surveillance and treatment planning, allowing for earlier interventions and improved long-term outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRD-Guided Surveillance in Locally Advanced Mid-Low Rectal Cancer | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients diagnosed with locally advanced mid-low rectal cancer (cT3/N+, M0, tumor ≤10 cm from the anal verge) who have not received prior treatment. Participants will be recruited from multiple clinical centers and must meet specific eligibility criteria to ensure the study's validity. Key Characteristics of the Study Population: Diagnosis: Histologically confirmed rectal adenocarcinoma (including adenocarcinoma, mucinous adenocarcinoma, signet-ring cell carcinoma, and undifferentiated carcinoma; excluding adenosquamous carcinoma). Stage: Clinical locally advanced mid-low rectal cancer (cT3/N+, M0) confirmed by preoperative imaging and clinical assessment. Treatment History: No prior chemotherapy, radiotherapy, targeted therapy, or other anti-cancer treatments. Surgical Eligibility: Candidates must be eligible for curative-intent surgery following neoadjuvant therapy. General Health Status: ECOG performance status 0-1, indicating good functional status
Key inclusion criteria (1 listed)
- 1） Age 18-80 years old, male or female; 2) histologically confirmed diagnosis of rectal adenocarcinoma (i.e., adenoepithelial carcinoma, including adenocarcinoma, mucinous carcinoma, imprinted cell carcinoma, and undifferentiated carcinoma; excluding adenosquamous carcinoma); 3) Preoperative clinical stage cT3 /N+, M0, the lower edge of the tumor is ≤10cm from the anal verge, and no surgical resection is performed; (4) Not receiving chemotherapy, radiotherapy, targeted therapy or other anti-tumor therapy; 5) Radical surgery is available; 6) ECOG score 0-1; 7) Subjects voluntarily enrolled in this study and signed the informed consent, good compliance, follow the planned schedule and actively cooperate with the return to the hospital for regular clinical follow-up and necessary treatment.
Key exclusion criteria (4 listed)
- previous other malignant tumors (including non-adenocarcinoma colorectal cancer);
- Previously received other anti-tumor therapy;
- Pregnant and lactating women; (4) Patients with other medical conditions that, in the judgment of the investigator, may interfere with follow-up and short-term survival;
- 5) Subjects have other factors that may lead to forced termination of this study, such as other serious illnesses (including mental illness, infectious diseases, fever ≥38℃, etc.) that require combined treatment, serious laboratory test abnormalities, accompanied by family or social factors that will affect the safety of the subjects, or the collection of data and samples.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exploring the correlation between MRD status and disease-free survival (DFS) in patients with locally progressive low and intermediate rectal cancer
Time frame: From surgery to disease recurrence or up to 36 months
Exploring the correlation between MRD status and disease-free survival (DFS) in patients with locally progressive low and intermediate rectal cancer
3 secondary outcomes
Correlation of MRD status with 1-year recurrence-free survival (1yRFS)
Time frame: From surgery to 12 months
Correlation of MRD status with 2-year event-free survival (2yRFS)
Time frame: From surgery to 24 months
Correlation of MRD status with overall survival (OS)
Time frame: From surgery to death or up to 36 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 17 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer (CRC), run by Fudan University.
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 1 inclusion and 4 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: opening soon, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploring the correlation between MRD status and disease-free survival (DFS) in patients with locally progressive low and intermediate rectal cancer (time frame: From surgery to disease recurrence or up to 36 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 17 Mar 2025.