Characterization of Rectal Cancer Hypoxia Using pO2 Histography and Immunohistochemistry for Hypoxia-Related Proteins

Not Applicable

Completed

• Conditions: Rectal Cancer
• Interventions: Procedure: Eppendorf hypoximeter

• Registration Number: NCT01189877
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to see if the cells in rectal cancer are oxygen-starved, or hypoxic. We know that as cancers grow bigger, parts of them are cut off from the oxygen supply and they become hypoxic, basically, lacking oxygen. Research has shown that cells that are oxygen-starved respond differently to treatment such as chemotherapy and radiation when compared to cells that are oxygen rich.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-25
• Study First Submitted QC: 2010-08-25
• Study First Posted: 2010-08-27
• Status Verified: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2012-10-10
• Last Update Posted: 2012-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Biopsy proven adenocarcinoma of the rectum. If a biopsy was taken at an outside hospital, the slides and diagnosis will be reviewed and confirmed by a pathologist at MSKCC.
• Mid to distal rectal tumors not requiring pre-op radiation or chemotherapy
• Age ≥ 18
• Age < 90
• Karnofsky performance status ≥ 60
• Ability to understand and the willingness to sign a written informed consent document.

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Exclusion Criteria

• Current pregnancy
• Uncontrolled intercurrent illness that would limit compliance with study requirements.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pO2 measurements	Eppendorf hypoximeter	In patients meeting eligibility requirements outlined below, comparisons will be made between direct pO2 measurements using a tissue hypoximeter and IHC-assessed expression of hypoxia related proteins (HIF-1α, VEGF, CA IX and GLUT-1) in both normal and tumor tissue.

Primary Outcome Measures

Name	Time	Method
Measure pO2 in rectal cancers	2 years	Measure pO2 in rectal cancers

Secondary Outcome Measures

Name	Time	Method
Correlate immunohistochemical analysis of endogenous markers of hypoxia	2 years	with direct tumor hypoximetry in tumor and normal tissue.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States