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Trial Title:
Detection of G-quadruplex DNA Methylation in Cancer
NCT ID:
NCT06537063
Condition:
Cancer
DNA G-quadruplex
Methylation
Cell-free DNA
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
G4 DNAm test
Description:
Detection of DNA methylation (DNAm) around G-quadruplex loci in cell-free DNA from blood.
Arm group label:
Asymptomatic population
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
42 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Hubei Locations
Address:
City:
Wuhan
Zip:
430071
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Xiao, Dr.
Phone:
+86-27-67811472
Start date:
April 30, 2024
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Zhongnan Hospital
Agency class:
Other
Source:
Zhongnan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06537063
