Cancer ScreeningNCT03096938
Cell-free DNA Methylation Markers for Cancer Screening
A study testing methylation markers screening in people with Cancer Screening, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the role of cell-free DNA methylation markers in cancer screening. Read more about this study
- Who is it for?
- Ages 40 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Screening
- What is being tested?
- methylation markers screening
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 1 May 2021
- Phase
- Interventional
- 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 40 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is average risk for development of cancer
- Subject able and willing to undergo screening test within 90 days of enrollment
- Subject is 40 to 74 years of age inclusive
- Subject is able to comprehend, sign, and date the written informed consent document to participate in the study
Who cannot join
- Subject has any condition which, in the opinion of the investigator should preclude participation in the study
- Subject has a history of cancer
- Participation in any "interventional" clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Hui-yan Luo, MD.PhD., 862087343008, luohy@sysucc.org.cn
Rui-hua Xu, MD.PhD., 862087343228, xurh@sysucc.org.cn
About this study
The purpose of this study is to evaluate the role of cell-free DNA methylation markers in cancer screening.
- Conditions
- Cancer Screening
- Being tested
- methylation markers screening
- Keywords
- cell-free DNA, methylation, markers, cancer, screening
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylation markers screeningDiagnostic test
Cell-free DNA extraction from plasma samples-Bisulfite conversion of cfDNA-Determination of DNA methylation levels by deep sequencing-Sequencing data analysis
| Study group | Role | What they receive |
|---|---|---|
| Normal screening group | Placebo comparator | patients receive the routine screening examination Receives: Diagnostic Test: methylation markers screening |
| methylation markers screening group | Experimental | patients receive the methylation markers screening Receives: Diagnostic Test: methylation markers screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity (true positive rate)
The proportion of persons with disease who have a positive test (positive test results among persons with disease)
Measured: 2 year
Specificity (true negative rate)
The proportion of persons without disease who have a negative test (negative test results among persons without disease)
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start1 Jun 2017
- Primary completion1 Oct 2020 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruihua Xu, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096938
- Sponsor's protocol ID
- cancer screening
- Status last verified
- Dec 2017
- First submitted
- 15 Mar 2017
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Imperiale TF, Ransohoff DF, Itzkowitz SH, Levin TR, Lavin P, Lidgard GP, Ahlquist DA, Berger BM. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014 Apr 3;370(14):1287-97. doi: 10.1056/NEJMoa1311194. Epub 2014 Mar 19.
PubMed 24645800
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell-free DNA Methylation Markers for Cancer Screening
- ClinicalTrials.gov ID
- NCT03096938
- Acronym / sponsor ID
- cancer screening
- Conditions
- Cancer Screening
- Keywords
- cell-free DNA, methylation, markers, cancer, screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 30 Mar 2017 (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.
The purpose of this study is to evaluate the role of cell-free DNA methylation markers in cancer screening.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal screening group | Placebo comparator | Diagnostic Test: methylation markers screeningpatients receive the routine screening examination |
| methylation markers screening group | Experimental | Diagnostic Test: methylation markers screeningpatients receive the methylation markers screening |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is average risk for development of cancer
- Subject able and willing to undergo screening test within 90 days of enrollment
- Subject is 40 to 74 years of age inclusive
- Subject is able to comprehend, sign, and date the written informed consent document to participate in the study
Key exclusion criteria (3 listed)
- Subject has any condition which, in the opinion of the investigator should preclude participation in the study
- Subject has a history of cancer
- Participation in any "interventional" clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups.
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 |
|---|---|---|
| methylation markers screeningCell-free DNA extraction from plasma samples-Bisulfite conversion of cfDNA-Determination of DNA methylation levels by deep sequencing-Sequencing data analysis | Diagnostic test | Normal screening group, methylation markers screening group |
Primary outcome
sensitivity (true positive rate)
Time frame: 2 year
The proportion of persons with disease who have a positive test (positive test results among persons with disease)
Specificity (true negative rate)
Time frame: 2 year
The proportion of persons without disease who have a negative test (negative test results among persons without disease)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.
- Results publication: PubMed 24645800Imperiale TF, Ransohoff DF, Itzkowitz SH, Levin TR, Lavin P, Lidgard GP, Ahlquist DA, Berger BM. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014 Apr 3;370(14):1287-97. doi: 10.1056/NEJMoa1311194. Epub 2014 Mar 19.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing methylation markers screening in people with Cancer Screening, run by Sun Yat-sen University 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Dec 2017. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity (true positive rate) (time frame: 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03096938, which also lists 1 linked publication.
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 27 Dec 2017.