Feasibility Study: Accuracy of Biomarker in Detection of Endometrial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00471120
Recruitment Status : Terminated (Study terminated due to protocol deficiencies.)
First Posted : May 9, 2007
Last Update Posted : August 5, 2015
Information provided by (Responsible Party):
Dick Domanik, CytoCore, Inc.

Brief Summary:
This study aims at developing an accurate, simple, and cost-effective method for screening and early detection of uterine cancers

Condition or disease Intervention/treatment Phase
Uterine Cancer Endometrial Cancer Other: P2x7 assay Not Applicable

Detailed Description:
The present study aims at developing an accurate, simple and cost-effective method for screening and early detection of uterine cancers in women using novel inventions and biotechnology methods for collection and assay of uterine cells. Results of P2X7 assays using tissues obtained from women with known uterine cancer and from women with histologically normal endometrium will be compared. These data will also serve as basis for future studies to test the predictive value of the method in population-based studies.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Feasibility Clinical Study: Accuracy of the P2X7 Biomarker in Detection of Endometrial Cancers in Women
Study Start Date : November 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : February 2008

Arm Intervention/treatment
Experimental: P2x7 Assay
Compare assay results with biopsy
Other: P2x7 assay
compare P2X7 assay to biopsy

Primary Outcome Measures :
  1. To determine the accuracy potential of the P2X7 (protein and mRNA levels) for the detection of uterine endometrial cancers in women. [ Time Frame: Upon review of the assays. ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • women scheduled to undergo hysterectomy
  • ages 18 years and older

Exclusion Criteria:

  • pregnant women
  • students or employees under the direct supervision on the investigators.

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 identifier (NCT number): NCT00471120

United States, Arkansas
University of Arkansas
Little Rock, Arkansas, United States, 72205-7199
United States, Ohio
University Hospital CASE Medical Center
Cleveland, Ohio, United States, 44106
United States, Texas
University of Texas
Dallas, Texas, United States, 75390-9032
University of Texas
Galveston, Texas, United States, 77555-0156
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23510
Sponsors and Collaborators
Dick Domanik
Principal Investigator: Jay Pinkerton, MD University Hospitals Cleveland Medical Center

Responsible Party: Dick Domanik, Scientist, CytoCore, Inc. Identifier: NCT00471120     History of Changes
Other Study ID Numbers: 13806-CC113
First Posted: May 9, 2007    Key Record Dates
Last Update Posted: August 5, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female