ClinicalTrials.gg
Status unknownNCT05638243METHOD-3Updated Dec 6, 2022

Evaluation of a Model for the Early Diagnosis of Colorectal Cancer by the Detection of 5-hydroxymethylcytosine (5-hmC) in Plasma Cell-free DNA to the Community Colorectal Cancer Screening Program

An observational study in Colorectal Cancer and Colorectal Neoplasms, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-06.

Sponsored by Fudan University · Observational

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
50 Years to 75 Years
Sex
All
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Study summary

The incidence rate and mortality of colorectal cancer are increasing year by year. Most colorectal cancer develops from colorectal adenoma and is a disease that can be prevented and controlled. Thanks to early screening, the incidence rate and mortality of colorectal cancer have declined year by year. However, due to poor compliance with colonoscopy and the lack of efficient and convenient early screening methods, it is difficult to screen for colorectal cancer in China. According to the data from Shanghai Xuhui District Center for Disease Control and Prevention, the proportion of colonoscopies in high-risk groups for colorectal cancer is less than 18%.

This project plans to use the latest colorectal cancer screening technology, namely, 5hmC detection in peripheral blood and DNA methylation detection in feces, for those who are positive in the colorectal cancer incidence risk questionnaire or fecal occult blood in Xuhui District, Shanghai. It is strongly recommended that subjects with positive screening should undergo colonoscopy, to effectively improve the rate of colonoscopy and the early diagnosis rate of colorectal cancer. At the same time, to explore the screening efficiency of the early diagnosis model of 5hmC cancer.

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Conditions studied

  • Colorectal Cancer
  • Colorectal Neoplasms
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In context

Colorectal Neoplasms

5,738 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 250 across 1,253 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.

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

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Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Residents of Xuhui District, Shanghai, who are initially screened as high-risk for colorectal cancer by Shanghai Xuhui District Center for Disease Control and Prevention, and do not receive a colonoscopy. People who are willing to accept the screening program.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 50 years old and\<75 years old;

    • The initial screening was positive (fecal occult blood or colorectal cancer risk questionnaire was positive); ③ Receive sample collection; ④ Sign the informed consent form.

Exclusion criteria

Exclusion Criteria:

① History of colorectal cancer, colorectal adenoma, and treatment;

  • Enteroscopy was performed after the initial screening was positive; ③ The subject or family members could not understand the conditions and objectives of the study or refused to participate in the study.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • High-risk residents
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What researchers measure

Primary outcomes

  1. Proportion of subjects receiving colonoscopy

    Proportion of subjects receiving colonoscopy

    Time frame: Three years

  2. Proportion of subjects suffering early colorectal cancer

    Proportion of stageⅠcancer in total colorectal cancer

    Time frame: Three years

  3. Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma

    Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma

    Time frame: Three years

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Study locations

1 of 1 sites recruiting
  • Community Health Centers in Xuhui District
    Shanghai, Shanghai Municipality 200032, China
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05638243
Lead sponsor
Fudan University
Responsible party
Xu jianmin (Director of Colorectal Surgery, Fudan University) — Principal investigator
First posted
Dec 6, 2022
Start date
Aug 20, 2022
Primary completion
Feb 2025 (estimated)
Completion
Sep 2025 (estimated)
Last update
Dec 6, 2022

Study contacts

Donghao Xu, M.D.
Contact
xdh1225@yeah.net
+86 17621317456
Jianmin Xu, M.D., PhD
principal investigator · Fudan University

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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