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NCT Number: NCT03486574

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

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

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Disease Attributes Disease Susceptibility Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Predisposition Genetic Predisposition to Disease Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Stomach Diseases Stomach Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

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

About this study

1> Patient selection

Enroll criteria:

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positive result from pathological test

Diagnostic Test

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Apr 3, 2018
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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