Clinical trial NCT00471120: Feasibility Study: Accuracy of Biomarker in Detection of Endometrial Cancer
Official title: Feasibility Clinical Study: Accuracy of the P2X7 Biomarker in Detection of Endometrial Cancers in Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Uterine Cancer
Endometrial Cancer
Lead sponsor: CytoCore, Inc.
Sponsor class: INDUSTRY
First posted: 2007-05-09
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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

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 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.

Primary outcomes:
measure: To determine the accuracy potential of the P2X7 (protein and mRNA levels) for the detection of uterine endometrial cancers in women.
timeFrame: Upon review of the assays.
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas
state: Arkansas
city: Cleveland
country: United States
facility: University Hospital CASE Medical Center
state: Ohio
city: Dallas
country: United States
facility: University of Texas
state: Texas
city: Galveston
country: United States
facility: University of Texas
state: Texas
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Jay Pinkerton, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1152/ajpcell.00256.2004. Epub 2004 Jul 21.
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. doi: 10.1210/en.2004-1026. Epub 2004 Sep 30.
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. doi: 10.1152/ajpcell.00315.2004. Epub 2005 Feb 23.
citation: 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):17228-17237. doi: 10.1074/jbc.M602999200. Epub 2006 Apr 18.
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. doi: 10.1158/1055-9965.EPI-06-0407.