Feasibility Study: Accuracy of Biomarker in Detection of Endometrial Cancer - Full Text View

Sponsored by:	CytoCore, Inc.
Information provided by:	CytoCore, Inc.
ClinicalTrials.gov Identifier:	NCT00471120

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

MedlinePlus related topics: Cancer Uterine Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Screening, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Feasibility Clinical Study: Accuracy of the P2X7 Biomarker in Detection of Endometrial Cancers in Women

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
Galveston, Texas, United States, 77555-0156
University of Texas
Dallas, Texas, United States, 75390-9032
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:

Wang Q, Wang L, Feng YH, Li X, Zeng R, Gorodeski GI. P2X7 receptor-mediated apoptosis of human cervical epithelial cells. Am J Physiol Cell Physiol. 2004 Nov;287(5):C1349-58. Epub 2004 Jul 21.

Wang L, Feng YH, Gorodeski GI. Epidermal growth factor facilitates epinephrine inhibition of P2X7-receptor-mediated pore formation and apoptosis: a novel signaling network. Endocrinology. 2005 Jan;146(1):164-74. Epub 2004 Sep 30.

Feng YH, Wang L, Wang Q, Li X, Zeng R, Gorodeski GI. ATP stimulates GRK-3 phosphorylation and beta-arrestin-2-dependent internalization of P2X7 receptor. Am J Physiol Cell Physiol. 2005 Jun;288(6):C1342-56. Epub 2005 Feb 23.

Feng YH, Li X, Wang L, Zhou L, Gorodeski GI. A truncated P2X7 receptor variant (P2X7-j) endogenously expressed in cervical cancer cells antagonizes the full-length P2X7 receptor through hetero-oligomerization. J Biol Chem. 2006 Jun 23;281(25):17228-37. Epub 2006 Apr 18.

Li X, Zhou L, Feng YH, Abdul-Karim FW, Gorodeski GI. The P2X7 receptor: a novel biomarker of uterine epithelial cancers. Cancer Epidemiol Biomarkers Prev. 2006 Oct;15(10):1906-13.

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

Study placed in the following topic categories:

Genital Diseases, Female
Endometrial Neoplasms
Genital Neoplasms, Female
Uterine Diseases

Uterine Neoplasms
Endometrial Cancer
Urogenital Neoplasms

Additional relevant MeSH terms:

Genital Diseases, Female
Neoplasms
Endometrial Neoplasms
Neoplasms by Site

Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009