NCT01484444

Brief Summary

BIOMARKER ANALYSES

  1. 1.FNA Sample:
  2. 2.Blood Samples From each enrolled patient who meets the inclusion criteria, blood samples will be collected. 3 mL blood sample will be collected .
  3. 3.tumor tissue Archived Tumor Tissue (Slides) Samples Primary tumor and/or a metastatic lesion collected. Approximately 5 unstained slides (if available) are collected.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 2, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Last Updated

December 6, 2011

Status Verified

December 1, 2011

Enrollment Period

1.9 years

First QC Date

November 22, 2011

Last Update Submit

December 4, 2011

Conditions

Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

  • Analyzed of DNA mutations

    To estimate genotypes concerning DNA repair (ERCC1, XPD, XRCC1) and detoxification (GSTP1)

    24months

Study Arms (1)

gastrointestinal cancer

Eligibility Criteria

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

Gastrointestinal cancer Patients.

You may qualify if:

  • Patients with histologically confirmed gastrointestinal cancer.
  • Patients should sign a written informed consent .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • won ki kang, MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

mi yeon Kwon, RN

CONTACT

+82-2-3410-1248miyeon.kwon@samsung.com

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 22, 2011

First Posted

December 2, 2011

Study Start

September 1, 2011

Primary Completion

August 1, 2013

Last Updated

December 6, 2011

Record last verified: 2011-12

Locations

KR(1)