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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

Study Description
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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.


Condition or disease
Colorectal Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Application of FIT-DNA Detection in Following Colorectal Cancer Resection-Implications for Surveillance
Actual Study Start Date : April 25, 2022
Estimated Primary Completion Date : November 30, 2026
Estimated Study Completion Date : January 31, 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05528783


Contacts
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Contact: Junzhong Lin +86-13802446666 linjzh@sysucc.org.cn
Contact: Zhizhong Pan +86-13719388166 panzhzh@sysucc.org.cn

Locations
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China, Guangdong
Colorectal Department,SunYat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510062
Contact: Junzhong lin, PhD    +86-13802446666    linjzh@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
New Horizon Health
More Information
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Responsible Party: ZHI-ZHONG PAN, Professor, Director, M.D., Ph.D, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT05528783    
Other Study ID Numbers: 2021-AFFCCR
First Posted: September 6, 2022    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Share to New Horizon Health

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ZHI-ZHONG PAN, Sun Yat-sen University:
Colorectal cancer
FIT-DNA
Detection
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases