Feasibility Study: Accuracy of Biomarker in Detection of Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title:

Feasibility Clinical Study: Accuracy of the P2X7 Biomarker in Detection of Endometrial Cancers in Women

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00471120
• Other study ID #: 13806-CC113
• Status: Terminated
• Phase: N/A
• First received: May 7, 2007
• Last updated: August 3, 2015
• Start date: November 2006
• Est. completion date: February 2008

Study information

• Verified date: August 2015
• Source: CytoCore, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: February 2008
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Uterine Cancer
• Uterine Neoplasms

Intervention

Other:
• P2x7 assay
compare P2X7 assay to biopsy

Locations

Country	Name	City	State
United States	University Hospital CASE Medical Center	Cleveland	Ohio
United States	University of Texas	Dallas	Texas
United States	University of Texas	Galveston	Texas
United States	University of Arkansas	Little Rock	Arkansas
United States	Eastern Virginia Medical School	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Dick Domanik

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the accuracy potential of the P2X7 (protein and mRNA levels) for the detection of uterine endometrial cancers in women.		Upon review of the assays.	No