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Clinical value of DNA methylation, protein and metabolic levels in peripheral blood in early screening of gastrointestinal malignancies

Clinical value of DNA methylation, protein and metabolic levels in peripheral blood in early screening of gastrointestinal malignancies

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500095967
Enrollment
Unknown
Registered
2025-01-15
Start date
2024-05-07
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

esophageal cancer, gastric cancer, colorectal cancer

Interventions

Sponsors

The Second Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: Gastrointestinal Malignant Tumor Group (1) Between the ages of 20 (inclusive) and 80 (inclusive), both male and female; (2) Patients with gastrointestinal malignancies such as esophageal cancer, gastric cancer, and colorectal cancer were first diagnosed by histopathological examination; (3) Did not receive any form of treatment (including surgery, radiotherapy, chemotherapy and immunotherapy, etc.) before peripheral blood sample collection; (4) It can provide complete medical history and complete postoperative pathological information. Non-cancer group of digestive tract (1) Between the ages of 20 (inclusive) and 80 (inclusive), both male and female; (2) Patients confirmed by histopathological examination as polyps, gastritis, ulcers and other non-cancer diseases of the digestive tract; (3) Did not receive any form of treatment (including surgery, radiotherapy, chemotherapy and immunotherapy, etc.) before peripheral blood sample collection; (4) It can provide complete medical history and complete postoperative pathological information. Group of healthy controls (1) Between the ages of 20 (inclusive) and 80 (inclusive), both male and female; (2) Colonoscopy report indicated no obvious abnormality; (3) The subject can provide a complete disease history.

Exclusion criteria

Exclusion criteria: Gastrointestinal Malignant Tumor Group (1) Patients with malignant lymphoma, neuroendocrine carcinoma, carcinoid, etc.; (2) the combination of any malignant tumor at any site other than the primary site of malignant tumor or any previous malignant tumor; (3) Diseases complicated with autoimmune diseases, acute/chronic infections, lymphoma and other diseases that may affect the expression and function of PBMCs in the body; (4) Patients who have received allogeneic blood transfusion or immune cell therapy within 1 year; (5) Blood samples are contaminated or appear hemolysis, lipemia and other phenomena. Non-cancer group of digestive tract (1) Serological or imaging findings indicate malignant tumors at any site; (2) Autoimmune diseases, acute/chronic infections, lymphoma and other immune diseases; (3) Patients who have received allogeneic blood transfusion or immune cell therapy within 1 year; (4) Laboratory examination results indicate abnormal function of major organs, liver and kidney; (5) Women who are pregnant or breastfeeding; (6) The peripheral blood sample is unqualified, and the phenomenon of hemolysis and lipemia occurs. Group of healthy controls (1) Serological or imaging findings indicate malignant tumors at any site; (2) Autoimmune diseases, acute/chronic infections, lymphoma and other immune diseases; (3) Patients who have received allogeneic blood transfusion or immune cell therapy within 1 year; (4) Laboratory examination results indicate abnormal function of major organs, liver and kidney; (5) Women who are pregnant or breastfeeding; (6) The peripheral blood sample is unqualified, and the phenomenon of hemolysis and lipemia occurs.

Design outcomes

Primary

MeasureTime frame
Area Under the Curve (AUC);sensitivity;

Secondary

MeasureTime frame
Specificity;Positive Predictive Value (PPV);Negative Predictive Value (NPV);

Countries

China

Contacts

Public ContactWang Chuanxin

The Second Hospital of Shandong University

cxwang@sdu.edu.cn+86 176 6008 1675

Outcome results

None listed

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