Study of Biomarkers in Tissue Samples From Patients With Metastatic Colon Cancer
This study has been withdrawn prior to enrollment.
Sponsor:
Georgetown University
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
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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:
Further study details as provided by Georgetown University:
| Enrollment: | 0 |
| Study Start Date: | January 2000 |
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 (Adult, Senior) |
| 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
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 Comprehensive Cancer Center |
More Information
| 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 |
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 |
ClinicalTrials.gov processed this record on September 27, 2016