Feasibility Study: Accuracy of Biomarker in Detection of Endometrial Cancer

This study has been terminated.
(Study terminated due to protocol deficiencies.)
Information provided by (Responsible Party):
Dick Domanik, CytoCore, Inc.
ClinicalTrials.gov Identifier:
First received: May 7, 2007
Last updated: August 3, 2015
Last verified: August 2015
This study aims at developing an accurate, simple, and cost-effective method for screening and early detection of uterine cancers

Condition Intervention
Uterine Cancer
Endometrial Cancer
Other: P2x7 assay

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Feasibility Clinical Study: Accuracy of the P2X7 Biomarker in Detection of Endometrial Cancers in Women

Resource links provided by NLM:

Further study details as provided by CytoCore, Inc.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2006
Study Completion Date: February 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: P2x7 Assay
Compare assay results with biopsy
Other: P2x7 assay
compare P2X7 assay to biopsy

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.

Ages Eligible for Study:   18 Years and older
Genders 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospital Case Medical Center
  More Information

Responsible Party: Dick Domanik, Scientist, CytoCore, Inc.
ClinicalTrials.gov Identifier: NCT00471120     History of Changes
Other Study ID Numbers: 13806-CC113
Study First Received: May 7, 2007
Last Updated: August 3, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 25, 2015