CancerNCT06537063
Detection of G-quadruplex DNA Methylation in Cancer
An observational study of Cancer and DNA G-quadruplex, run by Zhongnan Hospital at 1 site in China.
Trial summary
This study aims to evaluate the early diagnosis value of G-quadruplex DNA methylation in patients with cancer. Read more about this study
- Who is it for?
- Ages 42 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, DNA G-quadruplex, Methylation
- What is being tested?
- G4 DNAm test
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2024to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Healthy volunteers identified as asymptomatic during medical examination;
- Age≥42 years old;
- Voluntarily participate in this study and sign the informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Cancer, DNA G-quadruplex, Methylation, Cell-free DNA
- Being tested
- G4 DNAm test
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G4 DNAm testOther
Detection of DNA methylation (DNAm) around G-quadruplex loci in cell-free DNA from blood.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic population | Asymptomatic medical examination population. Receives: Other: G4 DNAm test |
What is being measured
The primary outcome is the main question the study is designed to answer.
G-quadruplex DNAm score
Detection of DNAm around G-quadruplex loci in cell-free DNA from blood.
Measured: 2024.04.30-2024.09.30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start30 Apr 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Why it stopped: The existing basic research and the latest literature reports do not support the proposed protocol, therefore, the project is withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Xiao, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537063
- Sponsor's protocol ID
- YX202401
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis Value of G-quadruplex DNA Methylation in Patients with Cancer
- ClinicalTrials.gov ID
- NCT06537063
- Acronym / sponsor ID
- YX202401
- Conditions
- Cancer, DNA G-quadruplex, Methylation, Cell-free DNA
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The existing basic research and the latest literature reports do not support the proposed protocol, therefore, the project is withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic population | – | Other: G4 DNAm testAsymptomatic medical examination population. |
Who may qualify
- Ages
- 42 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Healthy volunteers identified as asymptomatic during medical examination;
- Age≥42 years old;
- Voluntarily participate in this study and sign the informed consent.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G4 DNAm testDetection of DNA methylation (DNAm) around G-quadruplex loci in cell-free DNA from blood. | Other | Asymptomatic population |
Primary outcome
G-quadruplex DNAm score
Time frame: 2024.04.30-2024.09.30
Detection of DNAm around G-quadruplex loci in cell-free DNA from blood.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and DNA G-quadruplex, run by Zhongnan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
G-quadruplex DNAm score (time frame: 2024.04.30-2024.09.30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.