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RecruitingNCT05528783Updated Sep 21, 2022

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

An observational study in Colorectal Cancer, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-09-21.

Sponsored by Sun Yat-sen University · Observational

From the registry’s dates

  • Started Apr 2022; still recruiting 4 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • Colorectal cancer
  • FIT-DNA
  • Detection
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 200 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

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.

    Time frame: up to 5 years

Secondary outcomes

  1. 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.

    Time frame: up to 5 years

  2. 2.NPV、PPVof 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

  3. 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.

    Time frame: up to 5 years

07

Study locations

1 of 1 sites recruiting
  • Colorectal Department,SunYat-sen University Cancer Center
    Guangzhou, Guangdong 510062, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Share to New Horizon Health

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05528783
Lead sponsor
Sun Yat-sen University
Collaborators
New Horizon Health
Responsible party
ZHI-ZHONG PAN (Professor, Director, M.D., Ph.D, Sun Yat-sen University) — Principal investigator
First posted
Sep 6, 2022
Start date
Apr 25, 2022
Primary completion
Nov 30, 2026 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Sep 21, 2022

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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