MRD-Guided Surveillance in Locally Advanced Mid-Low Rectal Cancer (SURVEILLANCE-III)

NCT06879899 | Not Yet Recruiting DMC

• 1 other identifier: SURVEILLANCE-III
• Study Type: observational
• Target: 139
• 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 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.

Conditions

Colorectal Cancer (CRC)

Outcome Measures

Primary Outcomes (1)

• 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

  From surgery to disease recurrence or up to 36 months

Secondary Outcomes (3)

• Correlation of MRD status with 1-year recurrence-free survival (1yRFS)

  From surgery to 12 months

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

  From surgery to 24 months

• Correlation of MRD status with overall survival (OS)

  From surgery to death or up to 36 months

Other Outcomes (2)

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

  From surgery to disease recurrence, assessed up to 36 months

• Correlation between MRD status and pathologic complete remission rate (pCR) after neoadjuvant therapy

  From completion of neoadjuvant therapy to surgery

Study Arms (1)

MRD-Guided Surveillance in Locally Advanced Mid-Low Rectal 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 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

You may qualify if:

• ） 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.

You may not qualify if:

• 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;
• \) 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.

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: 3 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): July 31, 2027
• Study Completion (Estimated): July 31, 2029
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share