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


N/A
18 Years
N/A
Not Enrolling
Female
Uterine Cancer, Endometrial Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the accuracy potential of the P2X7 (protein and mRNA levels) for the detection of uterine endometrial cancers in women.

Outcome Time Frame:

Upon review of the assays.

Principal Investigator

Jay Pinkerton, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Case Medical Center

Authority:

United States: Institutional Review Board

Study ID:

13806-CC113

NCT ID:

NCT00471120

Start Date:

November 2006

Completion Date:

February 2008

Related Keywords:

  • Uterine Cancer
  • Endometrial Cancer
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Uterine Neoplasms
  • Adenoma

Name

Location

Eastern Virginia Medical SchoolNorfolk, Virginia  23507
University of ArkansasLittle Rock, Arkansas  72202
University of TexasHouston, Texas  77225
University Hospital Case Medical CenterCleveland, Ohio  44106