Esophageal CancerNCT05431621
Establishment of Molecular Classification Models for Early Diagnosis of Digestive System Cancers
An observational study of Esophageal Cancer and Gastric (Stomach) Cancer, run by Shanghai Zhongshan Hospital at 4 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophageal Cancer, Gastric (Stomach) Cancer, Colorectal Cancer
- Type of treatment
- Injection or infusion
- How many people
- 2,430 participants
- Where
- 4 sitesChina
- Study dates
- 15 Nov 2020to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
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- 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
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Xuhui Central Hospital, Shanghai
Shanghai, Shanghai Municipality, 200030
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200030
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201500
Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 201700
About this study
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.
Read the 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.
- Keywords
- ctDNA markers, DNA methylation, DNA fragment feature, miRNA, CTC, Cancer early detection
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Colorectal Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| Negative group | 985 healthy individuals. | |
| High risk group | 410 cases with precancerous diseases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish ctDNA-targeted sequencing models for early detection of esophageal, gastric, colorectal and hepatocellular cancer, and evaluate the diagnosis value
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.
Measured: assessed up to 1 year
Establish and evaluate the non-invasive early detection model for hepatocellular carcinoma
To establish and evaluate the early detection model for hepatocellular carcinoma based on ctDNA methylation detection, ctDNA low-pass WGS, miRNA7™ and CTC detection.
Measured: assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start15 Nov 2020
- Primary completion30 Jun 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2,430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xuhui Central Hospital, Shanghai, Changhai Hospital, Hubei Cancer Hospital, Shanghai Public Health Clinical Center, Singlera Genomics Inc.
- Responsible party
- Sponsor
- Investigators
- Jian Zhou, Doctor, Study director, Fudan UniversityYunshi Zhong, Doctor, Study director, Fudan UniversityRui Liu, Doctor, Principal investigator, Singlera Genomics Inc.Bin Yan, Doctor, Study director, Shanghai Zhongshan HospitalDongli He, Master, Study director, Xuhui Central Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431621
- Sponsor's protocol ID
- 2019YFC1315802-01
- Status last verified
- Jan 2025
- First submitted
- 19 Jun 2022
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28263317Chen 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.
PubMed 32694610Huang A, Guo DZ, Su ZX, Zhong YS, Liu L, Xiong ZG, He DL, Yan B, Li QL, Feng Z, Wang WQ, Lu PX, He MJ, Qi ZP, Guo Q, Cheng JW, Zhang SY, Guo W, Li Q, Lin GY, Sun HC, Qiu SJ, He QY, Fan J, Goel A, Liu R, Jin G, Yang XR, Zhou J. GUIDE: a prospective cohort study for blood-based early detection of gastrointestinal cancers using targeted DNA methylation and fragmentomics sequencing. Mol Cancer. 2025 Jun 5;24(1):163. doi: 10.1186/s12943-025-02367-x.
PubMed 40468355Guo DZ, Huang A, Wang YC, Zhou S, Wang H, Xing XL, Zhang SY, Cheng JW, Xie KH, Yang QC, Ma CC, Li Q, Chen Y, Su ZX, Fan J, Liu R, Liu XL, Zhou J, Yang XR. Early detection and prognosis evaluation for hepatocellular carcinoma by circulating tumour DNA methylation: A multicentre cohort study. Clin Transl Med. 2024 May;14(5):e1652. doi: 10.1002/ctm2.1652.
PubMed 38741204
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Molecular Classification Models for Early Diagnosis of Digestive System Cancers
- ClinicalTrials.gov ID
- NCT05431621
- Acronym / sponsor ID
- 2019YFC1315802-01
- Keywords
- ctDNA markers, DNA methylation, DNA fragment feature, miRNA, CTC, Cancer early detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,430 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Xuhui Central Hospital, Shanghai, Changhai Hospital, Hubei Cancer Hospital, Shanghai Public Health Clinical Center, Singlera Genomics Inc.
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 24 Jun 2022 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
| Negative group | – | –985 healthy individuals. |
| High risk group | – | –410 cases with precancerous diseases. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
Establish and evaluate the non-invasive early detection model for hepatocellular carcinoma
Time frame: assessed up to 1 year
To establish and evaluate the early detection model for hepatocellular carcinoma based on ctDNA methylation detection, ctDNA low-pass WGS, miRNA7™ and CTC detection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Background: PubMed 28263317Guo 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.
- Background: PubMed 32694610Chen 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.
- Derived from this study: PubMed 40468355Huang A, Guo DZ, Su ZX, Zhong YS, Liu L, Xiong ZG, He DL, Yan B, Li QL, Feng Z, Wang WQ, Lu PX, He MJ, Qi ZP, Guo Q, Cheng JW, Zhang SY, Guo W, Li Q, Lin GY, Sun HC, Qiu SJ, He QY, Fan J, Goel A, Liu R, Jin G, Yang XR, Zhou J. GUIDE: a prospective cohort study for blood-based early detection of gastrointestinal cancers using targeted DNA methylation and fragmentomics sequencing. Mol Cancer. 2025 Jun 5;24(1):163. doi: 10.1186/s12943-025-02367-x.
- Derived from this study: PubMed 38741204Guo DZ, Huang A, Wang YC, Zhou S, Wang H, Xing XL, Zhang SY, Cheng JW, Xie KH, Yang QC, Ma CC, Li Q, Chen Y, Su ZX, Fan J, Liu R, Liu XL, Zhou J, Yang XR. Early detection and prognosis evaluation for hepatocellular carcinoma by circulating tumour DNA methylation: A multicentre cohort study. Clin Transl Med. 2024 May;14(5):e1652. doi: 10.1002/ctm2.1652.
- 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. This study is not recruiting at the moment.
Jian Zhou, Doctor study director
Fudan University
Yunshi Zhong, Doctor study director
Fudan University
Rui Liu, Doctor principal investigator
Singlera Genomics Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Gastric (Stomach) Cancer, run by Shanghai Zhongshan Hospital at 4 sites 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 10 inclusion and 19 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: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05431621, which also lists 4 linked publications.
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 Jan 2025.