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Development and validation of a next generation sequencing-based non-invasive diagnostic system utilizing multiple types of plasma ctDNA markers for the early screen of digestive tract cancers

Development and validation of a next generation sequencing-based non-invasive diagnostic system utilizing multiple types of plasma ctDNA markers for the early screen of digestive tract cancers

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200060528
Enrollment
Unknown
Registered
2022-06-04
Start date
2022-05-25
Completion date
Unknown
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early gastrointestinal cancer

Interventions

Gold Standard:Pathological diagnosis

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18~80 years old, no gender restrictions, women are not during pregnancy and lactation; 2. Endoscopy and/or colonoscopy are acceptable; 3. The enrolled patients are newly diagnosed patients and have not received surgery, radiotherapy, chemotherapy, targeted therapy, or other tumor-related interventions; 4. Stop anticoagulant drugs such as warfarin, aspirin, and Plavix for 1 week, and stop low molecular weight heparin on the same day; 5. No history of other tumor diseases, normal liver and kidney function; 6. No major trauma requiring blood transfusion occurred within one week.

Exclusion criteria

Exclusion criteria: 1. Previously suffered from esophageal cancer, gastric cancer, intestinal cancer, and digestive tract 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. History of severe cardiovascular disease (such as the previous history of myocardial infarction, coronary artery bypass grafting or coronary stenting; history of congestive heart failure; myocardial infarction within 6 months, uncontrolled severe hypertension, etc.) and the investigators determine that they are not suitable for enrollment; 7. Participated in an "interventional" clinical trial within the past 30 days and took the trial drug; 8. Patients with other diseases who were judged by the investigator to be unsuitable for inclusion; 9. Failure to follow the test plan to collect blood on time; 10. The blood samples failed to meet the requirements.

Design outcomes

Primary

MeasureTime frame
DNA methylation;

Secondary

MeasureTime frame
Pathological diagnosis;

Countries

China

Contacts

Public ContactZhong Yunshi

Zhongshan Hospital, Fudan University

zhong.yunshi@zs-hospital.sh.cn+86 13564623481

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026