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

Colorectal Cancer Clinical Trial

Official title:

Assessment of Variation of PKA and Other Molecular Markers in Patients Undergoing Resection of Colon Cancer Metastases

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01012804
• Other study ID #: CDR0000078662
• Secondary ID: P30CA051008GUMC-
• Status: Withdrawn
• Phase: N/A
• First received: November 12, 2009
• Last updated: March 23, 2011
• Start date: January 2000

Study information

• Verified date: March 2011
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Genetic:
• western blotting

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

Locations

Country	Name	City	State
United States	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,