NCT02944539

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

Status
completed

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

Study Start

First participant enrolled

March 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

6 months

First QC Date

October 24, 2016

Last Update Submit

October 24, 2016

Conditions

Keywords

Mitochondrial DNA copy numberGastric cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Mitochondria are responsible for multiple cellular functions including regulation of energy production, modulation of oxidation-reduction status, generation of reactive oxygen species and apoptosis. Each mitochondrion possesses multiple copies of a mitochondrial genome comprised of independently replicating double stranded DNA (mtDNA).

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Department of Cardiology of Xijing Hospital

Study Record Dates

First Submitted

October 24, 2016

First Posted

October 26, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share