- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05431621
Establishment of Molecular Classification Models for Early Diagnosis of Digestive System Cancers
April 15, 2024 updated by: Singlera Genomics Inc.
This is a single blind, case control, multicenter study jointly developed by Zhongshan Hospital of Fudan University, Shanghai Public Health Clinical Center, Shanghai Xuhui Central Hospital, Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University, and Shanghai Singlera Genomics Company.
The enrolled population will include positive group, precancerous lesions and healthy control group, which is expected to enroll 2,430 participants.
The primary objective is to establish molecular testing methods for non-invasive screening and early diagnosis of digestive system cancers through ctDNA methylation and mutation, cfDNA and ctDNA fragment size, and end motif based model (for esophageal, gastric, colorectal cancer), and through ctDNA methylation detection, ctDNA low-pass WGS, miRNA7 and CTC detection and analysis technology based model (for hepatocellular carcinoma).
The sensitivity and specificity of the models in cancer early detection will be evaluated.
Study Overview
Status
Completed
Detailed Description
Design of the project: 1) Participants who sign informed consent forms will complete the disease history information collection;2) Collect samples of cancer tissue and corresponding paracancer samples, as well as peripheral blood; 3) Using the MONOD patent detection data of the company's previous research and combining with literature retrieval, to analyze the tissue samples of digestive system cancers to screen the methylation mutation sites;4) ctDNA methylation markers are preliminarily screened by plasma of healthy persons paired with tissues;5) Using the screened blood ctDNA specific methylation markers together with other molecular markers to establish a targeted detection method for early digestive system cancer lesions;6) Retain the most distinguishing targets in the original panel test and establish the second version of the panel;7) Establish and validate predictive models to finalize multitype molecular target detection for peripheral blood DNA;8) Construct statistical learning models based on ctDNA methylation and fragment features, miRNA7™ and CTC, and optimize the models respectively;9) Evaluate the sensitivity and specificity of the models in cancer early detection.
Study Type
Observational
Enrollment (Actual)
2430
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xinrong Yang, Doctor
- Phone Number: 18616881978
- Email: yang.xinrong@zs-hospital.sh.cn
Study Contact Backup
- Name: Rui Liu, Doctor
- Email: rliu@singleragenomics.com
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 201500
- Shanghai Public Health Clinical Center
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Shanghai, Shanghai, China, 200030
- Xuhui Central Hospital, Shanghai
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Shanghai, Shanghai, China, 200030
- Zhongshan Hospital of Fudan University
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Shanghai, Shanghai, China, 201700
- Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
This study aims to enroll 2430 participants from Zhongshan Hospital, Xuhui central hospitial, Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University and Shanghai Public Health Clinical Center.
Description
Colorectal cancer, Esophageal cancer and Gastric (stomach) cancer Group
Inclusion Criteria:
- Aged 18 to 80, no gender limitation, no pregnant or breastfeeding for women;
- Those who can accept gastroscopy and/or total colonoscopy;
- Newly-diagnosed patients who had not received surgery, radiotherapy, chemotherapy, targeted therapy or other anti-tumor intervention;
- Stop anticoagulant drugs such as warfarin, aspirin, and bolivir for 1 week, and stop low molecular weight heparin that day;
- No previous history of other tumor diseases, and no abnormalities in the liver and kidney;
- No major trauma requiring blood transfusion treatment within one week.
Exclusion Criteria:
- Previous esophageal cancer, stomach cancer, bowel cancer and gastrointestinal adenoma;
- Have a history of other cancers;
- Systemic inflammatory response syndrome;
- Previously experienced esophageal, gastric or colorectal adenoma removal or tumor resection;
- Patients with Lynch syndrome in the family;
- A history of severe cardiovascular disease (e.g., previous myocardial infarction, coronary artery bypass grafting, coronary stenting, congestive heart failure, myocardial infarction within 6 months, or uncontrolled severe hypertension, etc.) who were deemed unsuitable for inclusion by the investigator;
- Have participated in an "interventional" clinical trial within the past 30 days and have taken the experimental drug;
- Unsuitable for this trial determined by the researchers;
- Failure to collect blood on time according to plan;
- The blood sample does not meet the requirements.
Hepatocellular Carcinoma Group
Inclusion Criteria:
- Applicable to all enrolled volunteers (1) Aged 18 to 80, no gender limitation, no pregnant or breastfeeding for women; (2) No previous history of malignancy in other sites; (3) To avoid the risk of bleeding caused by taking anticoagulants during sampling, the following provisions shall be made according to different types of samples: stop anticoagulant drugs such as warfarin, aspirin, and bolivir for 1 week, and stop low molecular weight heparin that day; the doctor in charge decides whether to stop anticoagulant drugs before blood draw, according to the specific situation of the volunteers, ; (4) No major trauma requiring blood transfusion treatment within one week;
- Only for patients with hepatocellular carcinoma (HCC). (1) Diagnosed with stage I-IV hepatocellular carcinoma; (2) Newly-diagnosed patients with liver cancer, who had not received surgery, radiotherapy, chemotherapy, targeted therapy or other anti-tumor intervention;
- Only for high-risk groups (1) Diagnosis of child-Pugh grade A or B, chronic hepatitis B or cirrhosis; (2) No history of liver cancer or malignancy in other sites;
- For healthy people only (1) Normal liver function test results on the day of blood collection; (2) No history of hepatitis B, hepatitis C and cirrhosis; (3) No history of liver cancer or malignancy in other sites.
Exclusion Criteria:
- Patients with liver cancer who have received surgery, radiotherapy, chemotherapy, targeted therapy;
- Cancer patients except HCC, or patients with liver metastasis;
- Systemic inflammatory response syndrome;
- A history of severe cardiovascular disease (e.g., previous myocardial infarction, coronary artery bypass grafting, coronary stenting, congestive heart failure, myocardial infarction within 6 months, or uncontrolled severe hypertension, etc.) who were deemed unsuitable for inclusion by the investigator;
- Have participated in an "interventional" clinical trial within the past 30 days and have taken the experimental drug;
- Unsuitable for this trial determined by the researchers;
- Failure to collect blood on time according to plan;
- The blood sample does not meet the requirements.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Digestive system cancer group
A total of about 1035 cases are expected to be enrolled, including 432 cases in stage I and 603 cases in II-IV.
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Negative group
985 healthy individuals.
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High risk group
410 cases with precancerous diseases.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Establish ctDNA-targeted sequencing models for early detection of esophageal, gastric, colorectal and hepatocellular cancer, and evaluate the diagnosis value
Time Frame: assessed up to 1 year
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To discover the characteristic targets of ctDNA methylation, fragment, and mutation in esophageal, gastric, colorectal cancers, and hepatocellular carcinoma, and establish the early detection panel.
Then, evaluate the sensitivity and specificity of multi-cancer early detection models.
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assessed up to 1 year
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Establish and evaluate the non-invasive early detection model for hepatocellular carcinoma
Time Frame: assessed up to 1 year
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To establish and evaluate the early detection model for hepatocellular carcinoma based on ctDNA methylation detection, ctDNA low-pass WGS, miRNA7™ and CTC detection.
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assessed up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Jian Zhou, Doctor, Fudan University
- Study Director: Yunshi Zhong, Doctor, Fudan University
- Study Director: Bin Yan, Doctor, Shanghai Zhongshan Hospital
- Study Director: Dongli He, Master, Xuhui Central Hospital, Shanghai
- Principal Investigator: Rui Liu, Doctor, Singlera Genomics Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Guo S, Diep D, Plongthongkum N, Fung HL, Zhang K, Zhang K. Identification of methylation haplotype blocks aids in deconvolution of heterogeneous tissue samples and tumor tissue-of-origin mapping from plasma DNA. Nat Genet. 2017 Apr;49(4):635-642. doi: 10.1038/ng.3805. Epub 2017 Mar 6.
- Chen X, Gole J, Gore A, He Q, Lu M, Min J, Yuan Z, Yang X, Jiang Y, Zhang T, Suo C, Li X, Cheng L, Zhang Z, Niu H, Li Z, Xie Z, Shi H, Zhang X, Fan M, Wang X, Yang Y, Dang J, McConnell C, Zhang J, Wang J, Yu S, Ye W, Gao Y, Zhang K, Liu R, Jin L. Non-invasive early detection of cancer four years before conventional diagnosis using a blood test. Nat Commun. 2020 Jul 21;11(1):3475. doi: 10.1038/s41467-020-17316-z.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2020
Primary Completion (Actual)
June 30, 2023
Study Completion (Actual)
July 31, 2023
Study Registration Dates
First Submitted
June 19, 2022
First Submitted That Met QC Criteria
June 19, 2022
First Posted (Actual)
June 24, 2022
Study Record Updates
Last Update Posted (Actual)
April 17, 2024
Last Update Submitted That Met QC Criteria
April 15, 2024
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019YFC1315802-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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