Identification of Biomarkers for Early Detection of Pancreatic Cancer

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

Barbara Ann Karmanos Cancer Institute

ClinicalTrials.gov Identifier:

NCT00897494

First received: May 9, 2009

Last updated: September 8, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

May 9, 2009

Last Updated Date

September 8, 2011

Start Date ^ICMJE

February 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Identification of specific proteins of interest to evaluate for their potential role as markers for pancreatic cancer [ Time Frame: Upon collection when patient agrees to provide a one time venous blood collection ] [ Designated as safety issue: No ]
Analysis of serum proteins directly by mass spectrometry to identify new biomarkers of pancreatic cancer that can be used for early diagnosis [ Time Frame: After separation from the plasma ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Identification of specific proteins of interest to evaluate for their potential role as markers for pancreatic cancer [ Designated as safety issue: No ]
Analysis of serum proteins directly by mass spectrometry to identify new biomarkers of pancreatic cancer that can be used for early diagnosis [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00897494 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Identification of Biomarkers for Early Detection of Pancreatic Cancer

Official Title ^ICMJE

Michigan Center for Pancreatic Cancer Molecular Diagnosis: The Serum Protein Microarray Project

Brief Summary

RATIONALE: Studying samples of blood 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 is examining blood samples from patients with cancer to identify biomarkers that may help in the early detection of pancreatic cancer.

Detailed Description

OBJECTIVES:

Identify specific proteins of interest to evaluate for their potential role as markers for pancreatic cancer.
Analyze serum proteins directly by mass spectrometry to identify new biomarkers of pancreatic cancer that can be used for early diagnosis.

OUTLINE: Blood from patients is collected prior to treatment. Plasma proteins are analyzed by matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF/MS) and/or electrospray mass spectrometry (ESI/MS).

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

Venous blood

Sampling Method

Non-Probability Sample

Study Population

Venous blood collection samples from newly dianosed

Condition ^ICMJE

Pancreatic Cancer

Intervention ^ICMJE

Genetic: protein expression analysis
Venous blood collection
Other: laboratory biomarker analysis
Venous blood collection
Other: mass spectrometry
Venous blood collection
Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry
Venous blood collection

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2011

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Diagnosis of pancreatic cancer
- Newly diagnosed disease
Planning to undergo surgery or other treatment for pancreatic cancer at Karmanos Cancer Institute or its affiliates

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00897494

Other Study ID Numbers ^ICMJE

CDR0000479140, P30CA022453, WSU-C-2737, WSU-013105MP2E

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Barbara Ann Karmanos Cancer Institute

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Basil El-Rayes, MD

Barbara Ann Karmanos Cancer Institute

Information Provided By

Barbara Ann Karmanos Cancer Institute

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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