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

NCT05528783 | Recruiting

• 1 other identifier: 2021-AFFCCR
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer

Keywords

Colorectal cancer; FIT-DNA; Detection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 1.The AUC of FIT-DNA in recurrent CRC and advanced colorectal stage.

  up to 5 years

• 2.NPV、PPVof FIT-DNA in recurrent CRC and advanced colorectal stage.

  up to 5 years

• 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

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

Patients who were newly diagnosed with colorectal cancer by colorectal endoscopy and required surgical radical surgery for TNM stage I, II and III non-stoma patients

You may qualify if:

• ). 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；

You may not qualify if:

• Exit or terminate criteria：
• Follow-up information for the patients was not available
• Distant metastasis was diagnosed after surgery
• Subjects died before the end of follow-up.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• New Horizon Health: collaborator

Study Sites (1)

Colorectal Department,SunYat-sen University Cancer Center

Guangzhou, Guangdong, 510062, China

RECRUITING

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

Central Study Contacts

Junzhong Lin

CONTACT

+86-13802446666; linjzh@sysucc.org.cn

Zhizhong Pan

CONTACT

+86-13719388166; panzhzh@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director, M.D., Ph.D

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 6, 2022
• Study Start: April 25, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)