CRC (Colorectal Cancer)NCT07033156
An Exploratory Study on Gene Methylation Detection of Colorectal Cancer
An observational study of CRC (Colorectal Cancer) and Adenoma Colon, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- CRC (Colorectal Cancer), Adenoma Colon
- What is being tested?
- This study does not require intervention trials
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2024to 20 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hospital physical examination, outpatient, and inpatient patients;
Who may be able to join
- 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).
Who cannot join
- 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;
- Non-compliance with Sample Requirements: Samples that do not meet the collection and storage requirements;
- History of Disease: Subjects with a history or treatment of colorectal cancer (CRC) or advanced precancerous lesions;
- Insufficient Sample Volume: Samples with insufficient volume that cannot meet the requirements of the assessment system testing;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
zhenyuan qian, +86 13858195659, dr_qianzhenyuan@163.com
About this study
Official title: An Exploratory Study on Gene Methylation Detection of Colorectal Cancer（CRC）
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.
- Conditions
- CRC (Colorectal Cancer), Adenoma Colon
- Being tested
- This study does not require intervention trials
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This study does not require intervention trialsDiagnostic test
This study does not require intervention trials
What is being measured
The primary outcome is the main question the study is designed to answer.
human stool gene methylation
The core of the study is to detect the methylation levels of three genes in human stool samples. These three genes are SDC2, COL4A2, and C9orf50. The procedure includes stool sample collection, stool nucleic acid extraction, bisulfite conversion, and detection using the qMSP (quantitative Methylation-Specific PCR) method.
Measured: 2024.12-2025.8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start24 Dec 2024
- Primary completion20 Aug 2025 (estimated)
- Study completion20 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRC (Colorectal Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jinjiang Central Hospital, Xilingol League Central Hospital, Zybio Inc., Haining Central Hospital, Tiantai County People's Hospital, Xianju People's Hospital, Fuyang District People's Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Responsible party
- Principal investigator, Zhenyuan Qian, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033156
- Sponsor's protocol ID
- QT2024274
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on Gene Methylation Detection of Colorectal Cancer（CRC）
- ClinicalTrials.gov ID
- NCT07033156
- Acronym / sponsor ID
- QT2024274
- Conditions
- CRC (Colorectal Cancer), Adenoma Colon
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Jinjiang Central Hospital, Xilingol League Central Hospital, Zybio Inc., Haining Central Hospital, Tiantai County People's Hospital, Xianju People's Hospital, Fuyang District People's Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 24 Dec 2024 (actual)
- Primary completion
- 20 Aug 2025 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital physical examination, outpatient, and inpatient patients;
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- 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;
- Non-compliance with Sample Requirements: Samples that do not meet the collection and storage requirements;
- History of Disease: Subjects with a history or treatment of colorectal cancer (CRC) or advanced precancerous lesions;
- Insufficient Sample Volume: Samples with insufficient volume that cannot meet the requirements of the assessment system testing;
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This study does not require intervention trialsThis study does not require intervention trials | Diagnostic test | – |
Primary outcome
human stool gene methylation
Time frame: 2024.12-2025.8
The core of the study is to detect the methylation levels of three genes in human stool samples. These three genes are SDC2, COL4A2, and C9orf50. The procedure includes stool sample collection, stool nucleic acid extraction, bisulfite conversion, and detection using the qMSP (quantitative Methylation-Specific PCR) method.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CRC (Colorectal Cancer) and Adenoma Colon, run by Zhejiang Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zhenyuan qian (+86 13858195659, dr_qianzhenyuan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
human stool gene methylation (time frame: 2024.12-2025.8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.