Identification of Biomarkers for Early Detection of Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897494
• Other study ID #: CDR0000479140
• Secondary ID: P30CA022453WSU-C
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: March 7, 2016
• Start date: February 2005
• Est. completion date: April 2011

Study information

• Verified date: March 2016
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 2011
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Genetic:
• protein expression analysis
Venous blood collection

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

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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