Research for Associated Genes for Gastric Cancer in Family Member With Affected First-Degree Relatives

April 16, 2023 updated by: Nayoung Kim, Seoul National University Bundang Hospital

Research for Associated Genes for Developing Gastric Cancer in Family Member With First-Degree Relatives of Gastric Cancer

Familial gastric cancer accounts for 10% of all cases, but predisposing genetic variations is unknown except for CDH1 mutation.

Because Germline mutation is believed to be a key aspect of cancer predisposition, we plan to recruit persons with 2 or more affected family members in three-generation pedigree. The investigators will perform a whole-exome sequencing using DNA from blood samples of families including gastric cancer patients and non-gastric cancer patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

1> Patient selection

Enroll criteria:

1) Gastric cancer patients and their first-degree relatives and 2) family with two or more gastric cancer patients within three-generation pedigree.

A three-generation pedigree will be used for diagnostic consideration or risk assessment of rare variation.

Personal history will be acquired by questionnaire which asks smoking, alcohol intake, dietary preference, socioeconomic information and history of previous eradication of HP. For any family member with gastric cancer, age at diagnosis, histology type, methods of treatment or pathological reports will be evaluated.

2> Whole exome sequencing, variant annotation, filtering and prioritization After whole exome sequencing, functional annotation of genetic variants will be conducted using ANNOVAR.

3> Linkage analyses To perform variant and gene-based linkage analysis in pedigrees, data will be analyzed using pedigree-VAAST.

4> Validation using a genechip

Study Type

Observational

Enrollment (Actual)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The investigator will recruit or invite the participants among persons who visit the clinic with a family history of gastric cancer.

The investigator plans to recruit gastric cancer patients and non-patients in family with 2 or more affected members.

Non-gastric cancer patients was restricted to persons over 50 years of age.

Description

Inclusion Criteria :

  • Gastric cancer patients and their first-degree relatives
  • Members in family with two or more gastric cancer patients within three- generation pedigree

Exclusion Criteria :

  • Those who reject the enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gastric cancer
Pathologically proven diseases after upper gastroendoscopy and biopsy. Previous pathological reports and endoscopic image can be used.
Diagnostic test: Positive result from pathological test
Presence/absence of gastric cancer will be evaluated by upper gastroendoscopy or results of pathological test
non-gastric cnacer
Rull out gastric cancer by upper gastroendoscopy. The results 3 moths before enrollment is available.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genes with logarithm of odds (LOD)>2 in linkage analysis
Time Frame: 0 day (baseline)
Based on LOD at baseline, candidate genes will be selected.
0 day (baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2016

Primary Completion (Actual)

July 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

March 24, 2018

First Submitted That Met QC Criteria

March 31, 2018

First Posted (Actual)

April 3, 2018

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 16, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1610/366-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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