Using FIT-DNA detection to monitor colorectal cancer after surgery

Application of FIT-DNA Detection in Following Colorectal Cancer Resection-Implications for Surveillance

This study is testing a new way to use FIT-DNA technology to help monitor patients who have had surgery for colorectal cancer to see if it can catch any return of the disease early.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05528783 on ClinicalTrials.gov

What this trial studies

This observational study focuses on the application of FIT-DNA detection technology to monitor patients who have undergone radical surgery for colorectal cancer (CRC). It aims to assess the effectiveness of this non-invasive method in detecting recurrence and metastasis in high-risk patients during the mid- to long-term follow-up period. The study will include patients aged 18 to 80 who have been diagnosed with colorectal adenocarcinoma and have not received preoperative antitumor therapy. The goal is to improve surveillance strategies for CRC patients post-surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who have undergone radical surgery for colorectal adenocarcinoma without prior antitumor therapy.

Not a fit: Patients with a history of other digestive tract tumors or those requiring additional surgical interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to earlier detection of CRC recurrence and improve patient outcomes.

How similar studies have performed: While the application of FIT-DNA detection in CRC monitoring is novel in this context, similar approaches have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

* 1). The pathological diagnosis was colorectal adenocarcinoma； 2). Age: 18 to 80 years old,allgenders； 3). Radical surgery for CRC is required； 4). No preoperative antitumor therapy (including chemotherapy, radiation therapy, targeted therapy, and immunotherapy)； 5). Preoperative examination revealed no distant metastasis； 6). There were no severe hemorrhoids or other known conditions that can cause gastrointestinal bleeding before surgery； 7). The clinical treatment data were complete；

Exclusion Criteria:

* 1). With a history of digestive tract tumors other than CRC； 2). Previous colorectal surgery； 3). Patients requiring a fistula； 4). With complete intestinal obstruction or perforation； 5). Women who are pregnant or breastfeeding； 6). Patients with metastases found in other sites during surgery that cannot be removed radically； 7). Patients unwilling or unable to sign an informed consent form； 8). A strict vegetarian； 9). Patients who are unwilling to follow up according to the protocol or have poor follow-up compliance； 10). Any conditions that the study physician deemed inappropriate for inclusion。

Exit or terminate criteria：

1. . Follow-up information for the patients was not available
2. . Distant metastasis was diagnosed after surgery
3. . Subjects died before the end of follow-up.

Where this trial is running

Guangzhou, Guangdong

• Colorectal Department,SunYat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Junzhong Lin

Conditions Colorectal Cancer; Colorectal cancer; FIT-DNA; Detection