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Identification of Biomarkers for Early Detection of Pancreatic Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00897494
First Posted: May 12, 2009
Last Update Posted: March 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
  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 ]
  • 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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897494


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

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00897494     History of Changes
Other Study ID Numbers: CDR0000479140
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-C-2737
WSU-013105MP2E
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: March 9, 2016
Last Verified: March 2016

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 Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases