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

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ClinicalTrials.gov Identifier: NCT05528783
Recruitment Status : Recruiting
First Posted : September 6, 2022
Last Update Posted : September 21, 2022
Sponsor:
Collaborator:
New Horizon Health
Information provided by (Responsible Party):
ZHI-ZHONG PAN, Sun Yat-sen University

Tracking Information
First Submitted Date September 1, 2022
First Posted Date September 6, 2022
Last Update Posted Date September 21, 2022
Actual Study Start Date April 25, 2022
Estimated Primary Completion Date November 30, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 1, 2022)		 The diagnostic sensitivity and specificity of FIT-DNA detection for local recurrence and advanced colorectal neoplasm of CRC. [ Time Frame: up to 5 years ]
The diagnostic sensitivity and specificity of FIT-DNA detection for local recurrence and advanced colorectal neoplasm of CRC.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 1, 2022)
  • 1.The AUC of FIT-DNA in recurrent CRC and advanced colorectal stage. [ Time Frame: up to 5 years ]
    1.The AUC of FIT-DNA in recurrent CRC and advanced colorectal stage.
  • 2.NPV、PPVof FIT-DNA in recurrent CRC and advanced colorectal stage. [ Time Frame: up to 5 years ]
    2.NPV、PPVof FIT-DNA in recurrent CRC and advanced colorectal stage.
  • 3.The time interval between CRC recurrence and advanced colorectal neogenesis after the first positive appearance was detected by FIT-DNA detection. [ Time Frame: 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Application of FIT-DNA Detection in Following Colorectal Cancer Resection-Implications for Surveillance
Official Title Application of FIT-DNA Detection in Following Colorectal Cancer Resection-Implications for Surveillance
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Colorectal Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 1, 2022)		 200
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 31, 2027
Estimated Primary Completion Date November 30, 2026   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Junzhong Lin +86-13802446666 linjzh@sysucc.org.cn
Contact: Zhizhong Pan +86-13719388166 panzhzh@sysucc.org.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT05528783
Other Study ID Numbers 2021-AFFCCR
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Share to New Horizon Health
Current Responsible Party ZHI-ZHONG PAN, Sun Yat-sen University
Original Responsible Party Same as current
Current Study Sponsor Sun Yat-sen University
Original Study Sponsor Same as current
Collaborators New Horizon Health
Investigators Not Provided
PRS Account Sun Yat-sen University
Verification Date September 2022