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Study of Biomarkers in Tissue Samples From Patients With Metastatic Colon Cancer

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Georgetown University
ClinicalTrials.gov Identifier:
NCT01012804
First received: November 12, 2009
Last updated: March 23, 2011
Last verified: March 2011
History of Changes

November 12, 2009
March 23, 2011
January 2000
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Complete list of historical versions of study NCT01012804 on ClinicalTrials.gov Archive Site
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Study of Biomarkers in Tissue Samples From Patients With Metastatic Colon Cancer
Assessment of Variation of PKA and Other Molecular Markers in Patients Undergoing Resection of Colon Cancer Metastases

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

PURPOSE: This research study is looking at biomarkers in tissue samples from patients with metastatic colon cancer.

OBJECTIVES:

  • Determine the effect of surgical resection, in terms of physiological stress, on levels of tumor markers such as protein kinase A (PKA) expression in patients with metastatic colon cancer.
  • Estimate variation among patients of baseline tumor markers in tumor tissue and sera.
  • Correlate markers in tumor tissues with that in sera in these patients.
  • Establish a tissue bank of these specimens for future studies.

OUTLINE: Biopsy and surgical specimens are obtained before and during standard surgery (patients may have had tumor tissue obtained before study entry and stored). Serum samples and tumor tissue are analyzed by immunohistochemistry and western blot. Tumor markers (such as PKA expression) are determined and marker levels are measured in serum samples and tissues.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

patients with colorectal cancer
Colorectal Cancer
  • Genetic: western blotting
  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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DISEASE CHARACTERISTICS:

  • Diagnosis of colon cancer

    • Metastatic disease for which surgical resection is indicated
    • Metastatic disease accessible for tissue biopsy OR previously biopsied tissue is available

PATIENT CHARACTERISTICS:

  • Platelet count ≥ 80,000/mm^3
  • INR ≤ 1.3
  • PTT ≤ upper limit of normal
  • No history of bleeding disorders or abnormal clotting factors
  • No extrahepatic biliary obstruction

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01012804
CDR0000078662, P30CA051008, GUMC-00074, NCI-G01-1992
No
John Marshall, MD, Georgetown University
Georgetown University
National Cancer Institute (NCI)
Study Chair: John L. Marshall, MD Lombardi Cancer Research Center
Georgetown University
March 2011

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