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Genome-wide Association Study

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ClinicalTrials.gov Identifier: NCT01498757
Recruitment Status : Withdrawn (Registration poor)
First Posted : December 23, 2011
Last Update Posted : December 29, 2015
Sponsor:
Information provided by (Responsible Party):
Jeeyun Lee, Samsung Medical Center

Brief Summary:
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 or disease
Esophageal Squamous Cell Carcinoma.

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genome-wide Association Study to Predict Treatment Response for Chemotherapy in Esophageal Squamous Cell Carcinoma
Study Start Date : January 2012
Actual Primary Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Patients treated with Taxane/5-FU/platinum based chemo.



Primary Outcome Measures :
  1. Biomarkers predictive [ Time Frame: 24months ]
    Biomarkers predictive of clinical response to Taxane or 5-fluorouracil or platinum based chemotherapy.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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): NCT01498757


Locations
Korea, Republic of
Samsung medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center

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
First Posted: December 23, 2011    Key Record Dates
Last Update Posted: December 29, 2015
Last Verified: December 2015

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