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

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ClinicalTrials.gov Identifier: NCT01189877
Recruitment Status : Completed
First Posted : August 27, 2010
Last Update Posted : October 11, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: Eppendorf hypoximeter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Characterization of Rectal Cancer Hypoxia Using pO2 Histography and Immunohistochemistry for Hypoxia-Related Proteins
Study Start Date : August 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Arm Intervention/treatment
Experimental: pO2 measurements
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.
Procedure: Eppendorf hypoximeter
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 Measures :
  1. Measure pO2 in rectal cancers [ Time Frame: 2 years ]
    Measure pO2 in rectal cancers


Secondary Outcome Measures :
  1. Correlate immunohistochemical analysis of endogenous markers of hypoxia [ Time Frame: 2 years ]
    with direct tumor hypoximetry in tumor and normal tissue.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189877


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: José Guillem, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01189877    
Other Study ID Numbers: 10-121
First Posted: August 27, 2010    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: October 2012
Keywords provided by Memorial Sloan Kettering Cancer Center:
Direct pO2 Measurements
10-121
Additional relevant MeSH terms:
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Rectal Neoplasms
Hypoxia
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms