NCT01189877CompletedNot Applicable
Characterization of Rectal Cancer Hypoxia Using pO2 Histography and Immunohistochemistry for Hypoxia-Related Proteins
Memorial Sloan Kettering Cancer Center1 site in 1 country30 target enrollmentStarted: August 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Measure pO2 in rectal cancers
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 < 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.
Outcomes
Primary Outcomes
Measure pO2 in rectal cancers
Time Frame: 2 years
Measure pO2 in rectal cancers
Secondary Outcomes
- Correlate immunohistochemical analysis of endogenous markers of hypoxia(2 years)
Investigators
Study Sites (1)
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