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

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ClinicalTrials.gov Identifier: NCT03486574
Recruitment Status : Enrolling by invitation
First Posted : April 3, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Nayoung Kim, Seoul National University Bundang Hospital

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


Condition or disease Intervention/treatment
Gastric Cancer Genetic Predisposition Diagnostic Test: Positive result from pathological test

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


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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Research for Associated Genes for Developing Gastric Cancer in Family Member With First-Degree Relatives of Gastric Cancer
Actual Study Start Date : December 7, 2016
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
DNA from 10ml of plasma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486574


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital

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Responsible Party: Nayoung Kim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03486574     History of Changes
Other Study ID Numbers: B-1610/366-303
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Genetic Predisposition to Disease
Stomach Neoplasms
Disease Susceptibility
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Disease Attributes
Pathologic Processes