Clinical trial · Observational
Establishment of Molecular Classification Models for Early Diagnosis of Digestive System Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric (Stomach) Cancer | Childhood Gastric Carcinoma | ALIAS | 0.90 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Digestive system cancer group
- description
- A total of about 1035 cases are expected to be enrolled, including 432 cases in stage I and 603 cases in II-IV.
- label
- Negative group
- description
- 985 healthy individuals.
- label
- High risk group
- description
- 410 cases with precancerous diseases.
Primary outcomes (2)
- measure
- Establish ctDNA-targeted sequencing models for early detection of esophageal, gastric, colorectal and hepatocellular cancer, and evaluate the diagnosis value
- timeFrame
- assessed up to 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Colorectal cancer, Esophageal cancer and Gastric (stomach) cancer Group Inclusion Criteria: 1. Aged 18 to 80, no gender limitation, no pregnant or breastfeeding for women; 2. Those who can accept gastroscopy and/or total colonoscopy; 3. Newly-diagnosed patients who had not received surgery, radiotherapy, chemotherapy, targeted therapy or other anti-tumor intervention; 4. Stop anticoagulant drugs such as warfarin, aspirin, and bolivir for 1 week, and stop low molecular weight heparin that day; 5. No previous history of other tumor diseases, and no abnormalities in the liver and kidney; 6. No major trauma requiring blood transfusion treatment within one week. Exclusion Criteria: 1. Previous esophageal cancer, stomach cancer, bowel cancer and gastrointestinal adenoma; 2. Have a history of other cancers; 3. Systemic inflammatory response syndrome; 4. Previously experienced esophageal, gastric or colorectal adenoma removal or tumor resection; 5. Patients with Lynch syndrome in the family; 6. 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; 7. Have participated in an "interventional" clinical trial within the past 30 days and have taken the experimental drug; 8. Unsuitable for this trial determined by the researchers; 9. Failure to collect blood on time according to plan; 10. The blood sample does not meet the requirements. Hepatocellular Carcinoma Group Inclusion Criteria: 1. 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; 2. 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; 3. 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; 4. 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: 1. Patients with liver cancer who have received surgery, radiotherapy, chemotherapy, targeted therapy; 2. Cancer patients except HCC, or patients with liver metastasis; 3. Systemic inflammatory response syndrome; 4. 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; 5. Have participated in an "interventional" clinical trial within the past 30 days and have taken the experimental drug; 6. Unsuitable for this trial determined by the researchers; 7. Failure to collect blood on time according to plan; 8. The blood sample does not meet the requirements.
References
Publications (4)
- BACKGROUNDGuo 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. PMID 28263317
- BACKGROUNDChen 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. PMID 32694610
- DERIVEDHuang 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. PMID 40468355
- DERIVEDGuo 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. PMID 38741204