Gene Expression Profiles in Patients With Metastatic Panc... | NCT00897741

Studies
Gene Expression Profiles in Patients With Metastatic Pancreatic Cancer

NCT00897741

Sponsor

Barbara Ann Karmanos Cancer Institute

Status

Completed

Last Update Posted

Feb 11, 2014Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Pancreatic Cancer

Interventions

microarray analysis
laboratory biomarker analysis

Countries

United States

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

Feb 2014

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

Dec 2004

Primary Completion Date

May 2008Actual

Completion Date

Mar 2009Actual

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

Feb 10, 2014

Last Update Posted Date

Feb 11, 2014Estimated

Name	Class
National Cancer Institute (NCI)	NIH

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

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study uses gene expression profiling to compare primary tumor cells with metastatic tumor cells in patients with metastatic pancreatic cancer.

Detailed Description

OBJECTIVES:

Compare the gene expression profiles of pancreatic cancer cells from the primary and metastatic sites in patients with metastatic pancreatic cancer.
Characterize the function of the differentially upregulated and downregulated genes identified by comparing the gene expression profiles of primary and metastatic cells in these patients.

OUTLINE: Fresh biopsy samples are collected for gene expression profiling and other biomarker/laboratory analyses.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

Measure	Description	Time Frame
Gene expression profiles		at time of biopsy

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of pancreatic adenocarcinoma of exocrine origin
Metastatic disease
Fresh biopsy material available from primary site of disease and a metastatic focus, including liver, peritoneum, or lymph node

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

No prior chemotherapy or radiotherapy for pancreatic cancer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Cancer clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philip A. Philip, MD, PhD, FRCP	Barbara Ann Karmanos Cancer Institute	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Barbara Ann Karmanos Cancer Institute		Detroit	Michigan	48201	United States

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D046228	Microarray Analysis

Ancestor Terms

ID	Term
D046208	Microchip Analytical Procedures
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Link
P30CA022453	U.S. NIH Grant/Contract	View source
WSU-D-2841
WSU-HIC-091504M1E

Name	Type	Description	Arm Group Labels	Other Names
microarray analysis	Genetic
laboratory biomarker analysis	Other