Feasibility Study: Accuracy of Biomarker in Detection of Endometrial Cancer

Sponsor
Dick Domanik (Industry)
Overall Status
Terminated
CT.gov ID
NCT00471120
Collaborator
(none)
20
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1
15
4
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: P2x7 assay
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Feasibility Clinical Study: Accuracy of the P2X7 Biomarker in Detection of Endometrial Cancers in Women
Study Start Date :
Nov 1, 2006
Actual Primary Completion Date :
Apr 1, 2007
Actual Study Completion Date :
Feb 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: P2x7 Assay

Compare assay results with biopsy

Other: P2x7 assay
compare P2X7 assay to biopsy

Outcome Measures

Primary Outcome Measures

  1. 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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University of Arkansas Little Rock Arkansas United States 72205-7199
2 University Hospital CASE Medical Center Cleveland Ohio United States 44106
3 University of Texas Dallas Texas United States 75390-9032
4 University of Texas Galveston Texas United States 77555-0156
5 Eastern Virginia Medical School Norfolk Virginia United States 23510

Sponsors and Collaborators

  • Dick Domanik

Investigators

  • Principal Investigator: Jay Pinkerton, MD, University Hospitals Cleveland Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dick Domanik, Scientist, CytoCore, Inc.
ClinicalTrials.gov Identifier:
NCT00471120
Other Study ID Numbers:
  • 13806-CC113
First Posted:
May 9, 2007
Last Update Posted:
Aug 5, 2015
Last Verified:
Aug 1, 2015
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 5, 2015