Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-30 @ 3:17 AM
Study NCT ID:
NCT01012804
Status:
WITHDRAWN
Last Update Posted:
2011-03-24
First Post:
2009-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Biomarkers in Tissue Samples From Patients With Metastatic Colon Cancer
Sponsor:
Georgetown University
Organization:
Study Overview
Official Title:
Assessment of Variation of PKA and Other Molecular Markers in Patients Undergoing Resection of Colon Cancer Metastases
Status:
WITHDRAWN
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
PURPOSE: This research study is looking at biomarkers in tissue samples from patients with metastatic colon cancer.
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA051008 | NIH | None | https://reporter.nih.gov/quic… | View |
| GUMC-00074 | None | None | View | |
| NCI-G01-1992 | None | None | View |