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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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention
Colorectal Cancer
 Genetic: western blotting
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Variation of PKA and Other Molecular Markers in Patients Undergoing Resection of Colon Cancer Metastases

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Georgetown University:
Enrollment: 0
Study Start Date: January 2000
Detailed 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.

  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

patients with colorectal cancer

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
  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: NCT01012804

Locations
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
National Cancer Institute (NCI)
Investigators
Study Chair: John L. Marshall, MD Lombardi Cancer Research Center
  More Information

No publications provided

Responsible Party: John Marshall, MD, Georgetown University
ClinicalTrials.gov Identifier: NCT01012804     History of Changes
Other Study ID Numbers: CDR0000078662, P30CA051008, GUMC-00074, NCI-G01-1992
Study First Received: November 12, 2009
Last Updated: March 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Georgetown University:
stage IV colon cancer
recurrent colon cancer

ClinicalTrials.gov processed this record on March 03, 2015