Cell-free DNA Methylation Markers for Cancer Screening

Sun Yat-sen University

Status: Unknown

Conditions: Cancer Screening

Treatments: Diagnostic Test: methylation markers screening

Study type: Interventional

Funder types: Other

Identifiers

NCT03096938

cancer screening

Details and patient eligibility

About

The purpose of this study is to evaluate the role of cell-free DNA methylation markers in cancer screening.

Enrollment: 15,000 estimated patients

Sex: All

Ages: 40 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subject is average risk for development of cancer
2. Subject able and willing to undergo screening test within 90 days of enrollment
3. Subject is 40 to 74 years of age inclusive
4. Subject is able to comprehend, sign, and date the written informed consent document to participate in the study

Exclusion criteria

1. Subject has any condition which, in the opinion of the investigator should preclude participation in the study
2. Subject has a history of cancer
3. 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 design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15,000 participants in 2 patient groups, including a placebo group

Normal screening group

Placebo Comparator group

Description:

patients receive the routine screening examination

Treatment:

Diagnostic Test: methylation markers screening

methylation markers screening group

Experimental group

Description:

patients receive the methylation markers screening

Treatment:

Diagnostic Test: methylation markers screening