Genome-wide Association Study | NCT01498757

Studies
Genome-wide Association Study

NCT01498757

Sponsor

Samsung Medical Center

Status

Withdrawn

Last Update Posted

May 21, 2019Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Registration poor

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Jun 2012Actual

Completion Date

Jul 3, 2012Actual

First Submitted Date

Dec 21, 2011

First Submission Date that Met QC Criteria

Dec 21, 2011

First Posted Date

Dec 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2019

Last Update Posted Date

May 21, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jeeyun Lee, Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology, Samsung Medical CenterPrincipal Investigator

Lead Sponsor

Samsung Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
Patients treated with Taxane/5-FU/platinum based chemo.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Biomarkers predictive	Biomarkers predictive of clinical response to Taxane or 5-fluorouracil or platinum based chemotherapy.	24months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung medical Center		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D000077277	Esophageal Squamous Cell Carcinoma

Ancestor Terms

ID	Term
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided