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Genome-wide Association Study

This study is not yet open for participant recruitment.
Verified December 2011 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Jeeyun Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01498757
First received: December 21, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
  Purpose

To explore biomarkers predictive of clinical response to Taxane/5-FU/platinum based chemotherapy in esophageal squamous cell carcinoma. To identify negative predictive markers to 5-FU/platinum/Taxane. To elucidate signal transduction pathway attributable to 5-FU/platinum/Taxane resistance. To analyze correlation between the quantity of circulating tumor cells and circulating endothelial cell precursors and treatment response to Taxane/5-FU/platinum based chemotherapy.


Condition
Esophageal Squamous Cell Carcinoma.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genome-wide Association Study to Predict Treatment Response for Chemotherapy in Esophageal Squamous Cell Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Biomarkers predictive [ Time Frame: 24months ] [ Designated as safety issue: No ]
    Biomarkers predictive of clinical response to Taxane or 5-fluorouracil or platinum based chemotherapy.


Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients treated with Taxane/5-FU/platinum based chemo.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Esophageal squamous cell carcinoma Patients treated with Taxane/5-FU/platinum based chemotherapy.

Criteria

Inclusion Criteria:

  • Histological confirmed esophageal squamous cell carcinoma
  • Patients treated with Taxane or 5-FU or platinum based chemotherapy.
  • provision of a signed written informed consent.

Exclusion Criteria:

  • patients not signed written informed consent.
  • patient unacceptable for study in the judgement of the investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01498757

Contacts
Contact: mi yeon kwon, RN +82-2-3410-1248 miyeon.kwon@samsung.com

Locations
Korea, Republic of
Samsung medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: mi yeon kwon, RN     +82-2-3410-1248     miyeon.kwon@samsung.com    
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: Jeeyun Lee, Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01498757     History of Changes
Other Study ID Numbers: 2011-05-076
Study First Received: December 21, 2011
Last Updated: December 21, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 17, 2013