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Feasibility Study: Accuracy of Biomarker in Detection of Endometrial Cancer

This study has been terminated.
(After Preliminary results indicate need to make numerous changes to protocol, and therfore will end, rewrite, and then begin again.)
Sponsor:
Information provided by:
CytoCore, Inc.
ClinicalTrials.gov Identifier:
NCT00471120
First received: May 7, 2007
Last updated: June 13, 2008
Last verified: June 2008
History of Changes
  Purpose

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
 Procedure: P2X7 Assay

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Parallel 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:

U.S. FDA Resources

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. ]

Estimated Enrollment: 320
Study Start Date: November 2006
Study Completion Date: February 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471120

Locations
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
CytoCore, Inc.
Investigators
Principal Investigator: Jay Pinkerton, MD University Hospital Case Medical Center
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00471120     History of Changes
Other Study ID Numbers: 13806-CC113
Study First Received: May 7, 2007
Last Updated: June 13, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Uterine Neoplasms
Adenoma
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Neoplasms, Glandular and Epithelial
Uterine Diseases
Genital Diseases, Female
Sarcoma

ClinicalTrials.gov processed this record on May 19, 2013