Detection of G-quadruplex DNA Methylation in Cancer

Early Diagnosis Value of G-quadruplex DNA Methylation in Patients with Cancer

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

Study Overview

• Status: Withdrawn
• Conditions: Cancer; Methylation; Cell-free DNA; DNA G-quadruplex
• Intervention / Treatment: Other: G4 DNAm test

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 Type: Observational

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Hubei Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Healthy volunteers, aged 42 years or older, who are asymptomatic as determined by medical examination and willing to participate voluntarily in the study with signed informed consent.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Asymptomatic population; Asymptomatic medical examination population.	Other: G4 DNAm test; Detection of DNA methylation (DNAm) around G-quadruplex loci in cell-free DNA from blood.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
G-quadruplex DNAm score	Detection of DNAm around G-quadruplex loci in cell-free DNA from blood.	2024.04.30-2024.09.30

Collaborators and Investigators

• Sponsor: Zhongnan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 5, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: YX202401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No