NCT01470404

Brief Summary

To assess the role of germline polymorphisms in xenobiotic metabolism genes in toxicity profile. To assess the role of germline polymorphisms in genes associated with DNA repair, p53 tumor suppressor gene and angiogenesis pathway in predicting recurrence and survival in gastric cancer patients treated with adjuvant chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
792

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2008

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

July 10, 2008

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2013

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

4.8 years

First QC Date

November 9, 2011

Last Update Submit

January 15, 2018

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • germline polymorphisms in xenobiotic metabolism genes in toxicity profile

    36 months

Study Arms (1)

adjuvant chemotherapy

Patients enrolled on to the adjuvant XP trial + patients who received adjuvant chemotherapy following curative resection of gastric cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients enrolled on to the adjuvant trial will be considered as candidates for the study. Once the patient signed written informed consent, 10cc blood will be drawn in EDTA tube for DNA extraction.

You may qualify if:

  • gastric cancer patients treated with adjuvant chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • won ki kang, MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology

Study Record Dates

First Submitted

November 9, 2011

First Posted

November 11, 2011

Study Start

July 10, 2008

Primary Completion

May 10, 2013

Study Completion

July 10, 2013

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations

KR(1)