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Assessment of Variation of PKA and Other Molecular Markers in Patients Undergoing Resection of Colon Cancer Metastases


N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

Assessment of Variation of PKA and Other Molecular Markers in Patients Undergoing Resection of Colon Cancer Metastases


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

John L. Marshall, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Lombardi Cancer Research Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000078662

NCT ID:

NCT01012804

Start Date:

January 2000

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • recurrent colon cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms

Name

Location

Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007