Association Between Mitochondrial DNA Content and Risk of Gastric Cancer

Compelling epidemiological evidence indicates that alterations of mitochondrial DNA, including mutations and abnormal content of mitochondrial DNA (mtDNA), are associated with the initiation and development of gastric cancer.The aim of this study was to explore association between mtDNA content in peripheral blood cells could be used as a risk predictor for gastric cancer.

Study Overview

• Status: Completed
• Conditions: Stomach Neoplasms

• Study Type: Observational
• Enrollment (Actual): 600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A total of 300 eligible gastric cancer patients were anticipated to include in this study. Moreover, 300 healthy controls without previous cancer history were also recruited from individuals who visited investigator's hospital for physical examination during the same time period.

Description

Inclusion Criteria:

• 1.histological confirmed gastric adenocarcinoma; 2.receiving surgical resection; 3.no preoperative anticancer treatment; 4.alive at least 1 months after surgery.

Exclusion Criteria:

• 1.history of other malignancy; 2.blood transfusion within one month or prior bone marrow transplantation; 3.patients who reluctant to sign informed consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Gastric cancer group; 300 consecutive patients were recruited, who have diagnosed with gastric cancer by biopsy
Control group; The 300 healthy controls without previous cancer history were recruited from individuals who visited investigator's hospital for physical examination during the same time period as the case enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative copy number of mitochondrial DNA	The ratio of mitochondrial DNA contents to hemoglobin contents was calculated for each sample from standard curves. After that, the ratio for each sample was normalized to a calibrator DNA in order to standardize between different runs, and then defined as the measurement of relative mtDNA contents.Relative expression of mtDNA were measured in patients suffered from gastric cancer when compared with control group.	From date of percutaneous coronary intervention until the date of discharging from hospital, assessed up to 5 days

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 24, 2016
• First Submitted That Met QC Criteria: October 24, 2016
• First Posted (Estimate): October 26, 2016

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Gastric cancer; Mitochondrial DNA copy number
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: ZJ20161024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No