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

Primary Purpose

Rectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eppendorf hypoximeter
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rectal Cancer focused on measuring Direct pO2 Measurements, 10-121

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Exclusion Criteria:

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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pO2 measurements

Arm Description

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.

Outcomes

Primary Outcome Measures

Measure pO2 in rectal cancers
Measure pO2 in rectal cancers

Secondary Outcome Measures

Correlate immunohistochemical analysis of endogenous markers of hypoxia
with direct tumor hypoximetry in tumor and normal tissue.

Full Information

First Posted
August 25, 2010
Last Updated
October 10, 2012
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01189877
Brief Title
Characterization of Rectal Cancer Hypoxia Using pO2 Histography and Immunohistochemistry for Hypoxia-Related Proteins
Official Title
Characterization of Rectal Cancer Hypoxia Using pO2 Histography and Immunohistochemistry for Hypoxia-Related Proteins
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Direct pO2 Measurements, 10-121

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pO2 measurements
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Eppendorf hypoximeter
Intervention Description
Patients consented to the protocol will proceed to their surgery date without any change in the standard preoperative period. After arriving in the operating room, the patient will undergo intravenous general anesthesia (or spinal/epidural anesthesia) by the anesthesiologist and will receive 40% oxygen. At this time, the principal investigator (along with the assistance of the operating surgeon and a member of the Department of Medical Physics) will use the Eppendorf hypoximeter to gather pO2 measurements. We anticipate that this will add no more than fifteen minutes to the planned procedure. Once the measurements are collected, the anesthesia will be adjusted as appropriate for the surgery and the procedure will continue as usual.
Primary Outcome Measure Information:
Title
Measure pO2 in rectal cancers
Description
Measure pO2 in rectal cancers
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Correlate immunohistochemical analysis of endogenous markers of hypoxia
Description
with direct tumor hypoximetry in tumor and normal tissue.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Exclusion Criteria: Current pregnancy Uncontrolled intercurrent illness that would limit compliance with study requirements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Guillem, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan-Kettering Cancer Center

Learn more about this trial

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

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