MRD-Guided Surveillance in Resectable Stage IV Metastatic Colorectal Cancer (SURVEILLANCE-II)

NCT06879886 | Not Yet Recruiting DMC

• 1 other identifier: SURVEILLANCE-II
• Study Type: observational
• Target: 181
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to explore the relationship between minimal residual disease (MRD) status and disease recurrence in patients with resectable stage IV metastatic colorectal cancer (mCRC). 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 resectable stage IV mCRC and have not yet received any treatment will be enrolled. Blood samples will be collected at multiple time points, including before surgery, after surgery, and during follow-up visits over two years. The study will compare MRD status with 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 metastatic colorectal cancer patients.

Conditions

Colorectal Cancer (CRC); Colorectal Cancer Liver Metastases (CRLM)

Outcome Measures

Primary Outcomes (1)

• Exploring the correlation between MRD status and rate of disease recurrence (RFS) in people with stage IV metastatic resectable colorectal cancer

  Exploring the correlation between MRD status and rate of disease recurrence (RFS) in people with stage IV metastatic resectable colorectal cancer

  From surgery to disease recurrence or up to 24 months

Secondary Outcomes (4)

• Correlation of MRD status with 1-year event-free survival (1yEFS)

  From surgery to 12 months

• Correlation of MRD status with 2-year event-free survival (2yEFS)

  From surgery to 24 months

• Correlation of MRD status with 2-year recurrence-free survival (2yRFS)

  From surgery to 24 months

• Correlation of MRD status with overall survival (OS)

  From surgery to death or up to 24 months

Other Outcomes (1)

• MRD detects disease recurrence earlier than imaging (CT) average advance time

  From surgery to disease recurrence, assessed up to 24 months

Study Arms (1)

MRD-Guided Surveillance in Resectable Stage IV Metastatic Colorectal Cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients diagnosed with resectable stage IV metastatic colorectal cancer (mCRC) who have not received prior systemic 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 colorectal adenocarcinoma (including adenocarcinoma, mucinous adenocarcinoma, signet-ring cell carcinoma, and undifferentiated carcinoma; excluding adenosquamous carcinoma). Stage: Clinical stage IV disease, confirmed by preoperative imaging and clinical assessment as having resectable primary and metastatic lesions. Treatment History: No prior chemotherapy, radiotherapy, targeted therapy, or other anti-cancer treatments. Surgical Eligibility: Candidates must be eligible for curative-intent resection of both the primary tumor and metastatic lesions. General Health Status: ECOG performance status 0-1, indicating

You may qualify if:

• Age 18-80 years old, male or female;
• histologically confirmed primary foci of colorectal adenocarcinoma (i.e., adenoepithelial carcinoma, including adenocarcinoma, mucinous adenocarcinoma, imprinted cell carcinoma, and undifferentiated carcinoma; excluding adenosquamous carcinoma); (3) Preoperative stage IV and no surgical resection; (4) Not receiving chemotherapy, radiotherapy, targeted therapy or other anti-tumor therapy;
• \) Surgical resection of primary/metastatic foci is possible; 6) ECOG score 0-1; 7) Subjects voluntarily enrolled in the study and signed the informed consent, good compliance, and actively cooperate with the regular clinical follow-up clinic back in the hospital.

You may not qualify if:

• Previous other malignant tumors (including non-adenocarcinoma colorectal cancer);
• Pregnant and lactating women;
• Patients with other concurrent illnesses that, in the judgment of the investigator, may interfere with follow-up and short-term survival;
• The subject has other factors that may cause this study to be forced to be terminated halfway, such as other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory test abnormalities, accompanied by family or social factors that would affect the safety of the subject, or the collection of data and samples.

Sponsors & Collaborators

• Fudan University: lead

Biospecimen

Retention: SAMPLES WITH DNA

In this study, the specific types of samples that will be retained are peripheral blood samples collected from patients at multiple time points. These samples will be used for circulating tumor DNA (ctDNA) analysis to assess minimal residual disease (MRD) status.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Colorectal Surgery Department, Zhongshan hospital, Fudan University

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share