Gene Expression Profiling in Normal Tissue and Tumor Tiss... | NCT00896753

Studies
Gene Expression Profiling in Normal Tissue and Tumor Tissue From Patients With Colon Cancer That Has Spread to the Liver, Lungs, or Peritoneum

NCT00896753

Sponsor

Wake Forest University Health Sciences

Status

Completed

Last Update Posted

May 30, 2017Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Colorectal Cancer
Metastatic Cancer

Interventions

Not provided

Countries

Not provided

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

Sep 2015

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 2003

Primary Completion Date

Sep 2006Actual

Completion Date

May 2008Actual

First Submitted Date

May 9, 2009

First Submission Date that Met QC Criteria

May 9, 2009

First Posted Date

May 12, 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

May 25, 2017

Last Update Posted Date

May 30, 2017Actual

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

RATIONALE: Studying the genes expressed in samples of tissue from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This laboratory study is using gene expression profiling to evaluate normal tissue and tumor tissue from patients with colon cancer that has spread to the liver, lungs, or peritoneum.

Detailed Description

OBJECTIVES:

Evaluate gene expression profiles in normal and tumor tissue from patients with colon cancer metastatic to the liver, lungs, or peritoneum.
Establish cell lines from primary colon tumors metastatic to the liver, lungs, or peritoneum.
Determine the specific gene expression changes that result in the manifestation of the drug-resistant phenotype for each metastatic site.

OUTLINE: This is a pilot study.

Tumor and normal tissue collected during surgery are analyzed for gene expression profiling by cDNA microarray. Tissue is also analyzed for thymidylate synthase (TS) gene expression by quantitative PCR and for protein expression by western blot. Gene expression patterns are correlated with TS levels.

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

10Actual

Label	Type	Description	Intervention Names
patients with metastatic colon cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gene expression changes that occur at each metastatic site (i.e., liver, lungs, and peritoneum)		day 1
Development of cell lines from primary colon tumors metastatic to the liver, lungs, or peritoneum		day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of colon cancer metastatic to the liver, lungs, or peritoneum

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Not specified

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

120 Years

Standard Ages

ChildAdultOlder Adult

Study Population

patients with metastatic colen cancer

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Perry Shen, MD	Wake Forest University Health Sciences	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D009362	Neoplasm Metastasis
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
CCCWFU-89B03
CCCWFU-BG03-403