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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05528783
• Other study ID #: 2021-AFFCCR
• Status: Recruiting
• Start date: April 25, 2022
• Est. completion date: January 31, 2027

Study information

• Verified date: September 2022
• Source: Sun Yat-sen University
• Contact: Junzhong Lin
• Phone: +86-13802446666
• Email: linjzh[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Colorectal cancer (CRC) is a common cancer that threatens human health, with the incidence ranking the third in the world. 70% of patients are in the middle and late stages whendiagnosed, and even after radical surgery, 30% - 50% of patients with CRC have recurrence or metastasis after radical surgery. Therefore, after radical surgery and adjuvant chemotherapy, regular monitoring of CRC patients should be paid attention to in order to detect the recurrence and metastasis lesions that can be resected and the early non-invasive metachronous multiple primary tumors. The sensitivity of FIT-DNA to CRC was 95.5%, the sensitivity to advanced adenoma (AA) was 63.5%, and the specificity was 87.5%, showing a good ability to screen colorectal cancer and precancerous lesions. At present, there is no report on the application of FIT-DNA combined detection technology in the high-risk recurrence period and mid - and long-term monitoring after CRC surgery in China. In this study, Fit-DNA combined detection technology was applied to the follow-up monitoring of patients after CRC surgery, so as to optimize the current typical postoperative follow-up strategy, find early recurrence and multiple primary colorectal tumors after CRC surgery, seek the best postoperative follow-up model, improve the compliance of patients to follow-up, and ultimately benefit survival. Detailed Description:Outline:This study was a single-center, observational study. Fit-DNA detection technology was used as a target method, and colonoscopy was used as the gold standard control to follow up and monitor patients with colorectal tumors after surgery, and to explore whether it is an effective non-invasive auxiliary method for monitoring CRC recurrence and metastasis and multiple primary colorectal tumors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 31, 2027
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
China	Colorectal Department,SunYat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	New Horizon Health

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The diagnostic sensitivity and specificity of FIT-DNA detection for local recurrence and advanced colorectal neoplasm of CRC.	The diagnostic sensitivity and specificity of FIT-DNA detection for local recurrence and advanced colorectal neoplasm of CRC.	up to 5 years
Secondary	1.The AUC of FIT-DNA in recurrent CRC and advanced colorectal stage.	1.The AUC of FIT-DNA in recurrent CRC and advanced colorectal stage.	up to 5 years
Secondary	2.NPV?PPVof FIT-DNA in recurrent CRC and advanced colorectal stage.	2.NPV?PPVof FIT-DNA in recurrent CRC and advanced colorectal stage.	up to 5 years
Secondary	3.The time interval between CRC recurrence and advanced colorectal neogenesis after the first positive appearance was detected by FIT-DNA detection.	3.The time interval between CRC recurrence and advanced colorectal neogenesis after the first positive appearance was detected by FIT-DNA detection.	up to 5 years