MRD-Guided Surveillance in Operable Colon Adenocarcinoma (I-III)(SURVEILLANCE-I)

NCT06879873 | Not Yet Recruiting DMC

• 1 other identifier: SURVEILLANCE-I
• Study Type: observational
• Target: 390
• 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 stage I-III operable colon adenocarcinoma. 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 test to detect circulating tumor DNA (ctDNA) and assess its ability to predict cancer recurrence and survival outcomes. Patients who are newly diagnosed with stage I-III colon adenocarcinoma and are eligible for surgery will be enrolled. Blood samples will be collected at multiple time points, including before surgery, after surgery, and during follow-up visits over three 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 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 colon cancer patients.

Conditions

Colorectal Cancer (CRC)

Outcome Measures

Primary Outcomes (1)

• Exploring the correlation between MRD status and disease recurrence rate (RFS) in stage I-III operable colon adenocarcinoma

  Exploring the correlation between MRD status and disease recurrence rate (RFS) in stage I-III operable colon adenocarcinoma

  From surgery until disease recurrence or up to 36 months, whichever occurs first

Secondary Outcomes (3)

• The correlation between MRD status and 1-year recurrence free survival (1yRFS)

  From surgery until 12 months post-surgery

• The correlation between MRD status and 2-year recurrence free survival (2yRFS)

  From surgery until 24 months post-surgery

• The correlation between MRD status and overall survival (OS)

  From surgery until death or up to 36 months, whichever occurs first

Other Outcomes (1)

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

  From surgery until disease recurrence or up to 36 months, whichever occurs first

Study Arms (1)

MRD-Guided Surveillance of I-III CRC

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 stage I-III resectable colon adenocarcinoma 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 colon adenocarcinoma (including adenocarcinoma, mucinous adenocarcinoma, signet-ring cell carcinoma, and undifferentiated carcinoma; excluding adenosquamous carcinoma). Stage: Clinical stage I-III, 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. General Health Status: ECOG performance status 0-1, indicating good functional status. Age Range: 18 to 80 years old. Consent \& Compliance: Participants must provide informed consent and be willing

You may qualify if:

• Age range: 18-80 years old, male or female not limited;
• Histologically confirmed colon adenocarcinoma (i.e. adenocarcinoma, including adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, undifferentiated carcinoma; excluding adenosquamous cell carcinoma);
• Preoperative staging of stages I-III, without undergoing endoscopic ESD or EMR surgical resection;
• Not receiving chemotherapy, radiotherapy, targeted therapy, or other anti-tumor treatments;
• Radical surgery can be performed;
• ECOG score 0-1 points;
• The subjects voluntarily joined this study and signed an informed consent form, demonstrating good compliance and actively cooperating to return to the hospital for regular clinical follow-up diagnosis and treatment.

You may not qualify if:

• Previously suffered from other malignant tumors (including non adenocarcinoma colorectal cancer);
• Pregnant and lactating women;
• According to the researchers' assessment, the patient also suffers from other diseases that may affect follow-up and short-term survival
• Subjects have other factors that may lead to the forced termination of this study, such as other serious diseases (including mental illness, infectious diseases, fever ≥ 38 ℃, etc.) requiring combined treatment, serious laboratory examination abnormalities, accompanied by family or social factors, which will affect the safety of 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