Pharmacogenomic Study to Predict Neurotoxicity of Oxalipl... | NCT00977717

Studies
Pharmacogenomic Study to Predict Neurotoxicity of Oxaliplatin

NCT00977717

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Apr 19, 2010Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Curatively Resected Stage III Colon Cancer

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

Apr 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Jan 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Sep 3, 2009

First Submission Date that Met QC Criteria

Sep 14, 2009

First Posted Date

Sep 16, 2009Estimated

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

Apr 15, 2010

Last Update Posted Date

Apr 19, 2010Estimated

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

In order to explore genetic factors that may determine the neurotoxicity of oxaliplatin-based chemotherapy, germinal gene polymorphisms will be analyzed.

Detailed Description

To investigate the impact of single nucleotide (SNP) polymorphism on the toxicity profile in colorectal cancer patients treated with FOLFOX chemotherapy, 10 cc of blood will be drawn in EDTA tube for extraction. DNA will be extracted from peripheral blood samples using DNA isolation kit, and SNP polymorphisms will be evaluated.

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

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FOLFOX		Stage III colorectal cancer patients who are treated with adjuvant FOLFOX chemotherapy

Interventions

Not provided

Measure	Description	Time Frame
neuropathy		six months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged 18 or older
curatively resected colon adenocarcinoma
pathologically staged III
adequate performance status
adequate major organ functions
to be treated with adjuvant FOLFOX chemotherapy
written informed consent

Exclusion Criteria:

those who disagree the study

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

Curatively resected stage III colon cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Se Hoon Park, MD	Samsung Medical Center, Seoul, Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul		135 710	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21253319	Derived	Baek KK, Lee J, Park SH, Park JO, Park YS, Lim HY, Kang WK, Cho YB, Yun SH, Kim HC, Lee WY, Chun HK. Oxaliplatin-induced chronic peripheral neurotoxicity: a prospective analysis in patients with colorectal cancer. Cancer Res Treat. 2010 Dec;42(4):185-90. doi: 10.4143/crt.2010.42.4.185. Epub 2010 Dec 31.