Cell-free DNA Methylation Markers for Cancer Screening

NCT ID: NCT03096938

Last Updated: 2017-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2021-05-01

Brief Summary

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

Detailed Description

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Conditions

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Cancer Screening

Keywords

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cell-free DNA methylation markers cancer screening

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Normal screening group

patients receive the routine screening examination

Group Type PLACEBO_COMPARATOR

methylation markers screening

Intervention Type DIAGNOSTIC_TEST

Cell-free DNA extraction from plasma samples-Bisulfite conversion of cfDNA-Determination of DNA methylation levels by deep sequencing-Sequencing data analysis

methylation markers screening group

patients receive the methylation markers screening

Group Type EXPERIMENTAL

methylation markers screening

Intervention Type DIAGNOSTIC_TEST

Cell-free DNA extraction from plasma samples-Bisulfite conversion of cfDNA-Determination of DNA methylation levels by deep sequencing-Sequencing data analysis

Interventions

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methylation markers screening

Cell-free DNA extraction from plasma samples-Bisulfite conversion of cfDNA-Determination of DNA methylation levels by deep sequencing-Sequencing data analysis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Ruihua Xu

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Hui-yan Luo, MD.PhD.

Role: primary

Rui-hua Xu, MD.PhD.

Role: backup

References

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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.

Reference Type RESULT
PMID: 24645800 (View on PubMed)

Other Identifiers

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cancer screening

Identifier Type: -

Identifier Source: org_study_id