NCT07033156Recruiting
An Exploratory Study on Gene Methylation Detection of Colorectal Cancer
An Exploratory Study on Gene Methylation Detection of Colorectal Cancer(CRC)
Source: ClinicalTrials.gov · Last updated 29 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this exploration study is to evaluate the performance of a colorectal cancer (CRC) early screening model based on the DNA methylation technology platform. The study focuses on individuals over the age of 40 and aims to identify and verify methylation biomarkers for colorectal cancer using stool samples . The main question it aims to answer is: Can a DNA methylation-based model effectively detect colorectal cancer and adenoma in individuals over 40 using non-invasive stool samples? Participants will provide stool samples for methylation analysis. The study results will be used solely for internal product performance evaluation and optimization by the sponsor and will not be used for product registration or influence any clinical diagnosis.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 450 (estimated)
- First submitted
- 13 Jun 2025
- Start date
- Dec 2024
- Primary completion date
- Aug 2025
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07033156
What you commit to
- Study type: Observational
- Planned participants: 450
- From Dec 2024 to the primary completion date, Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unclear Sample Collection Information: Samples with unclear collection time, or stool samples not collected within 3 months prior to colonoscopy, or samples with incomplete clinical information that cannot be traced;
Other illness
- History of Disease: Subjects with a history or treatment of colorectal cancer (CRC) or advanced precancerous lesions;
- Hereditary Diseases: Subjects with a diagnosis or family history of the following diseases:Familial adenomatous polyposis (FAP), including attenuated FAP and Gardner syndrome;Hereditary nonpolyposis colorectal cancer syndrome (HNPCC or Lynch syndrome);Other hereditary cancer syndromes, including but not limited to Peutz-Jeghers syndrome, MYH-associated polyposis (MAP), Turcot syndrome (or Crail syndrome), Cowden syndrome, juvenile polyposis, neurofibromatosis, or familial proliferative polyposis (FAP);
- Inflammatory Bowel Disease (IBD): Subjects with a diagnosis or personal history of IBD, including chronic ulcerative colitis and/or Crohn's disease;
- Cronkhite-Canada Syndrome: Subjects with a diagnosis of Cronkhite-Canada syndrome.
Other
- Non-compliance with Sample Requirements: Samples that do not meet the collection and storage requirements;
- Insufficient Sample Volume: Samples with insufficient volume that cannot meet the requirements of the assessment system testing;
Who the study is looking for
- Sample Source: Hospital physical examination, outpatient, and inpatient patients;
- Patient Information: Patient information (such as age, hospital ID number, gender, clinical diagnosis, colonoscopy and pathology results) is traceable;
- Age Requirement: ≥ 40 years old;
- Sampling Time Requirement: Stool and plasma samples must be collected within 3 months prior to colonoscopy (stool samples are preferred).
Age in the registry: 40 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Provincial People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.