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Withdrawn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
|
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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 |
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 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 |

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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 |
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

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
United States, District of Columbia | |
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | |
Washington, District of Columbia, United States, 20007 |
Study Chair: | John L. Marshall, MD | Lombardi Comprehensive Cancer Center |
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 |