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

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Georgetown University

Status

Withdrawn

Conditions

Colorectal Cancer

Treatments

Other: laboratory biomarker analysis
Genetic: western blotting
Other: immunohistochemistry staining method

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT01012804
CDR0000078662
P30CA051008 (U.S. NIH Grant/Contract)
GUMC-00074
NCI-G01-1992

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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