Gastric CancerNCT03486574
Research for Associated Genes for Gastric Cancer in Family Member With Affected First-Degree Relatives
An observational study of Gastric Cancer and Genetic Predisposition, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer, Genetic Predisposition
- What is being tested?
- Positive result from pathological test
- How many people
- 105 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Dec 2016to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Gastric cancer patients and their first-degree relatives
- Members in family with two or more gastric cancer patients within three- generation pedigree
Who cannot join
- Those who reject the enrollment
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: 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
Read the detailed description
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
- Conditions
- Gastric Cancer, Genetic Predisposition
- Being tested
- Positive result from pathological test
- Medical subject headings
- Stomach Neoplasms, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive result from pathological testDiagnostic test
Presence/absence of gastric cancer will be evaluated by upper gastroendoscopy or results of pathological test
| Study group | Role | What they receive |
|---|---|---|
| Gastric cancer | Pathologically proven diseases after upper gastroendoscopy and biopsy. Previous pathological reports and endoscopic image can be used. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genes with logarithm of odds (LOD)>2 in linkage analysis
Based on LOD at baseline, candidate genes will be selected.
Measured: 0 day (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start7 Dec 2016
- Primary completion31 Jul 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayoung Kim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486574
- Sponsor's protocol ID
- B-1610/366-303
- Status last verified
- Apr 2023
- First submitted
- 24 Mar 2018
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research for Associated Genes for Developing Gastric Cancer in Family Member With First-Degree Relatives of Gastric Cancer
- ClinicalTrials.gov ID
- NCT03486574
- Acronym / sponsor ID
- B-1610/366-303
- Conditions
- Gastric Cancer, Genetic Predisposition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 7 Dec 2016 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 3 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric cancer | – | Diagnostic Test: Positive result from pathological testPathologically proven diseases after upper gastroendoscopy and biopsy. Previous pathological reports and endoscopic image can be used. |
| non-gastric cnacer | – | –Rull out gastric cancer by upper gastroendoscopy. The results 3 moths before enrollment is available. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Gastric cancer patients and their first-degree relatives
- Members in family with two or more gastric cancer patients within three- generation pedigree
Key exclusion criteria (1 listed)
- Those who reject the enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive result from pathological testPresence/absence of gastric cancer will be evaluated by upper gastroendoscopy or results of pathological test | Diagnostic test | Gastric cancer |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Genetic Predisposition, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genes with logarithm of odds (LOD)>2 in linkage analysis (time frame: 0 day (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.