NCT06537063

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

January 7, 2025

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

July 31, 2024

Last Update Submit

January 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • G-quadruplex DNAm score

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

    2024.04.30-2024.09.30

Study Arms (1)

Asymptomatic population

Asymptomatic medical examination population.

Other: G4 DNAm test

Interventions

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

Asymptomatic population

Eligibility Criteria

Age42 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hubei Locations

Wuhan, Hubei, 430071, China

Location

MeSH Terms

Conditions

Neoplasms
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 31, 2024

First Posted

August 5, 2024

Study Start

April 30, 2024

Primary Completion

September 30, 2024

Study Completion

December 30, 2024

Last Updated

January 7, 2025

Record last verified: 2024-07

Locations