Identification of Biomarkers for Early Detection of Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00897494
First received: May 9, 2009
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Pancreatic Cancer
Genetic: protein expression analysis
Other: laboratory biomarker analysis
Other: mass spectrometry
Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Michigan Center for Pancreatic Cancer Molecular Diagnosis: The Serum Protein Microarray Project

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Venous blood


Enrollment: 75
Study Start Date: February 2005
Study Completion Date: April 2011
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Venous blood collection samples from newly dianosed

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897494

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Principal Investigator: Fazlul Sarkar, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00897494     History of Changes
Other Study ID Numbers: CDR0000479140, P30CA022453, WSU-C-2737, WSU-013105MP2E
Study First Received: May 9, 2009
Last Updated: March 4, 2014
Health Authority: United States: Federal Government

Keywords provided by Barbara Ann Karmanos Cancer Institute:
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014