Detection of G-quadruplex DNA Methylation in Cancer

Withdrawn

• Conditions: Methylation; Cell-free DNA; DNA G-quadruplex; Cancer
• Interventions: Other: G4 DNAm test

• Registration Number: NCT06537063
• Lead Sponsor: Zhongnan Hospital

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.

Study Timeline

• Study Start: 2024-04-30
• Status Verified: 2024-07
• Study First Submitted: 2024-07-31
• Study First Submitted QC: 2024-07-31
• Study First Posted: 2024-08-05
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-30
• Last Update Submitted: 2025-01-05
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Asymptomatic population	G4 DNAm test	Asymptomatic medical examination population.

Primary Outcome Measures

Name	Time	Method
G-quadruplex DNAm score	2024.04.30-2024.09.30	Detection of DNAm around G-quadruplex loci in cell-free DNA from blood.

Trial Locations

Locations (1)

Hubei Locations; 🇨🇳 Wuhan, Hubei, China