Feasibility Study: Accuracy of Biomarker in Detection of Endometrial Cancer

NCT ID: NCT00471120

Last Updated: 2015-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-02-29

Brief Summary

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

Detailed Description

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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.

Conditions

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Uterine Cancer Endometrial Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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P2x7 Assay

Compare assay results with biopsy

Group Type EXPERIMENTAL

P2x7 assay

Intervention Type OTHER

compare P2X7 assay to biopsy

Interventions

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P2x7 assay

compare P2X7 assay to biopsy

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dick Domanik

INDUSTRY

Sponsor Role lead

Responsible Party

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Dick Domanik

Scientist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jay Pinkerton, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

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University of Arkansas

Little Rock, Arkansas, United States

Site Status

University Hospital CASE Medical Center

Cleveland, Ohio, United States

Site Status

University of Texas

Dallas, Texas, United States

Site Status

University of Texas

Galveston, Texas, United States

Site Status

Eastern Virginia Medical School

Norfolk, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15269006 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15459114 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15728711 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16624800 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17035398 (View on PubMed)

Other Identifiers

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13806-CC113

Identifier Type: -

Identifier Source: org_study_id

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