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

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ClinicalTrials.gov Identifier: NCT01012804
Recruitment Status : Withdrawn
First Posted : November 13, 2009
Last Update Posted : March 24, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Georgetown University

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment
Colorectal Cancer Genetic: western blotting Other: immunohistochemistry staining method Other: laboratory biomarker analysis

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.


Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
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
Study Start Date : January 2000
Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): 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 Comprehensive Cancer Center
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: John Marshall, MD, Georgetown University
ClinicalTrials.gov Identifier: NCT01012804     History of Changes
Other Study ID Numbers: CDR0000078662
P30CA051008 ( U.S. NIH Grant/Contract )
GUMC-00074
NCI-G01-1992
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: March 24, 2011
Last Verified: March 2011

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases