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Completed

NCT Number: NCT01189877

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

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eppendorf hypoximeter

Procedure

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 outcomes

  1. Measure pO2 in rectal cancers

    Time frame: 2 years

    Measure pO2 in rectal cancers

Secondary outcomes

  1. Correlate immunohistochemical analysis of endogenous markers of hypoxia

    Time frame: 2 years

    with direct tumor hypoximetry in tumor and normal tissue.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 27, 2010
Registry last updated
Oct 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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