Discovery and Validation of Plasma DNA Methylation Biomarker for Detection of Stomach Cancer
2 other identifiers
observational
440
1 country
1
Brief Summary
Background: Stomach cancer is common around the world. The US is a low-risk region. But the 5-year survival rate in the US is low. This is because the cancer is usually in a late stage by the time it is diagnosed. One way to detect it earlier is to screen many people with a procedure called endoscopy. But this may not be feasible in low-risk or developing countries. Researchers want to find a biomarker for early-stage disease to help them create an effective way of screening. DNA methylation is a chemical modification of DNA. It generates a signal for certain cancers, including stomach cancer. Researchers want to find a blood-based DNA methylation marker for stomach cancer. Objective: To study plasma DNA methylation as a potential biomarker for detection of stomach cancer. Eligibility: Participants from 2 studies already done in China Design: Researchers will use blood samples from participants in the 2 studies. The blood was collected in 1999/2000. They will use samples from some who developed stomach cancer between those years and 2006. The other samples will be from some who stayed cancer free in that time. Participants already gave written informed consent. Researchers will take DNA from the samples. They will look for methylation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2017
Typical duration for all trials
1 active site
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
First Submitted
Initial submission to the registry
March 9, 2017
CompletedStudy Start
First participant enrolled
March 9, 2017
CompletedFirst Posted
Study publicly available on registry
March 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2020
CompletedFebruary 25, 2020
February 1, 2020
2.9 years
March 9, 2017
February 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relation of DNA methylation marakers to gastric cancer status
Relation of markers tested to cancer
ongoing
Study Arms (2)
case
Stomach cancer cases from two previously conducted studies in China
control
Controls from two previously conducted studies in China
Eligibility Criteria
Nutrition Intervention Trials (NIT) - Community Sample Shanxi - Hospital and community samples@@@@@@
You may qualify if:
- Data samples already exist from 2 other IRB approved studies (OH99-C-N031, OH95-C-N027)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cancer Institute (NCI)
Bethesda, Maryland, 20892, United States
Biospecimen
Testing pre-existing serum samples from 2 ongoing studies covered by other SSIRB approvals - OH95-C-N027-G (Esophageal CA Genetic Studies) and PH99-C-N031-H (Nutritional Intervention Trials in Linxian China - Continued Follow-Up)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alisa M Goldstein, Ph.D.
National Cancer Institute (NCI)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2017
First Posted
March 10, 2017
Study Start
March 9, 2017
Primary Completion
February 14, 2020
Study Completion
February 21, 2020
Last Updated
February 25, 2020
Record last verified: 2020-02