NCT02041312

Brief Summary

Investigators have a plan to conduct nested case-control study to investigate the association between serum cholesterol levels including TC, HDL-C, LDL-C, triglyceride (TG), apolipoproteins and gastric neoplasm. In addition, further analyses were performed to evaluate the possible role of the serum cholesterol as a predictor for the differentiation and prognosis of gastric neoplasm.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,178

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

4.8 years

First QC Date

January 2, 2014

Last Update Submit

December 4, 2016

Conditions

Keywords

CholesterolGastric cancerStage

Outcome Measures

Primary Outcomes (1)

  • Cholesterol level in paitents with and withoutgastric neoplasm

    Serum cholesterol levels including TC, HDL-C, LDL-C, triglyceride (TG), apolipoproteins will be checked and compared in paitents with and withoutgastric neoplasm.

    up to 24 months

Secondary Outcomes (1)

  • Degree of decresed serum cholesterol levels in paitents with gastric neoplasm

    up to 24 months

Study Arms (1)

Gastric cancer

No intervention

Other: No intervention

Interventions

No intervention will be needed.

Gastric cancer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All subjects who visited the department of gastroenterology, surgery, or Healthcare Screening \& Promotion Center at Asan Medical Center and diagnosed as gastric cancer

You may qualify if:

  • All subjects who visited the department of gastroenterology, surgery, or Healthcare Screening \& Promotion Center at Asan Medical Center and diagnosed as gastric cancer

You may not qualify if:

  • Subjects who has history about drug for cholesterol, diabetes, liver disease, and/or thyroid disease.
  • Subjects who do not want to be enrolled this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center

Seoul, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

endoscopic biopsy specimen of gastric mucosa surgically resected specimen of stomach

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Hwoon-Yong Jung, M.D., PhD.

    Asan Medical Center

    STUDY CHAIR

Central Study Contacts

Ji Yong Ahn, M.D., PhD.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 2, 2014

First Posted

January 22, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

December 6, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations