Detection of G-quadruplex DNA Methylation in Cancer

NCT ID: NCT06537063

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2024-12-30

Brief Summary

This study aims to evaluate the early diagnosis value of G-quadruplex DNA methylation in patients with cancer.

Detailed Description

Global DNA hypomethylation is a hallmark of most cancers that occurs early during oncogenesis. We would like to investigate whether cancer-specific transcription factor binding to DNA G-quadruplex drives DNA hypomethylation in cancer. In this observational study, we would like to clarify whether DNA hypomethylation around G-quadruplex loci in cell-free DNA could be detected in early-stage cancer patients from healthy donors with high sensitivity and specificity.

Conditions

Cancer; DNA G-quadruplex; Methylation; Cell-free DNA

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Asymptomatic population

Asymptomatic medical examination population.

G4 DNAm test

Intervention Type: OTHER

Detection of DNA methylation (DNAm) around G-quadruplex loci in cell-free DNA from blood.

Interventions

G4 DNAm test

Detection of DNA methylation (DNAm) around G-quadruplex loci in cell-free DNA from blood.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers identified as asymptomatic during medical examination;
• Age≥42 years old;
• Voluntarily participate in this study and sign the informed consent.

Exclusion Criteria

• History of malignancy or having achieved complete remission following tumor surgery;
• Certain autoimmune diseases (e.g., systemic lupus erythematosus, Sjögren's syndrome, antiphospholipid syndrome, rheumatoid arthritis, Crohn's disease, IgA nephropathy, myasthenia gravis, dermatomyositis, immune thrombocytopenic purpura, etc.);
• Pregnancy;
• Acute trauma (including surgical procedures), sudden onset organ failure (e.g., resulting from a car accident, fulminant hepatic failure, acute pancreatitis, severe pneumonia due to influenza virus), or diagnosis of sepsis;
• Previous receipt of allogeneic blood transfusion, transplant surgery, or allogeneic cell therapy;
• Volunteers who cannot provide informed consent.

• Minimum Eligible Age: 42 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhongnan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yu Xiao

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hubei Locations

Wuhan, Hubei, China

Countries

China

Other Identifiers

YX202401

Identifier Type: -

Identifier Source: org_study_id