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WithdrawnNCT06537063Updated Jan 7, 2025

Detection of G-quadruplex DNA Methylation in Cancer

An observational study in Cancer, DNA G-quadruplex and Methylation, sponsored by Zhongnan Hospital. Withdrawn at 1 site in China. Open to participants aged 42 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-07.

Sponsored by Zhongnan Hospital · Observational

Why this study was withdrawn
The existing basic research and the latest literature reports do not support the proposed protocol, therefore, the project is withdrawn.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
42 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cancer
  • DNA G-quadruplex
  • Methylation
  • Cell-free DNA
03

In context

Lead sponsor

Zhongnan Hospital is the lead sponsor of 103 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
42 Years and older
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Asymptomatic population

    Asymptomatic medical examination population.

    Other: G4 DNAm test

Interventions

  • OtherG4 DNAm test

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

06

What researchers measure

Primary outcomes

  1. G-quadruplex DNAm score

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

    Time frame: 2024.04.30-2024.09.30

07

Study locations

1 site
  • Hubei Locations
    Wuhan, Hubei 430071, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06537063
Lead sponsor
Zhongnan Hospital
Responsible party
Yu Xiao (Director, Zhongnan Hospital) — Principal investigator
First posted
Aug 5, 2024
Start date
Apr 30, 2024
Primary completion
Sep 30, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Jan 7, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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