NCT03486574

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 7, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

5.6 years

First QC Date

March 24, 2018

Last Update Submit

April 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Genes with logarithm of odds (LOD)>2 in linkage analysis

    Based on LOD at baseline, candidate genes will be selected.

    0 day (baseline)

Study Arms (2)

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

non-gastric cnacer

Rull out gastric cancer by upper gastroendoscopy. The results 3 moths before enrollment is available.

Interventions

Presence/absence of gastric cancer will be evaluated by upper gastroendoscopy or results of pathological test

Gastric cancer

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Those who reject the enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA from 10ml of plasma

MeSH Terms

Conditions

Stomach NeoplasmsGenetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

March 24, 2018

First Posted

April 3, 2018

Study Start

December 7, 2016

Primary Completion

July 31, 2022

Study Completion

December 31, 2022

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations