Back to resultsFeasibility Study: Accuracy of Biomarker in Detection of Endometrial Cancer
Primary Purpose
Uterine Cancer, Endometrial Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
P2x7 assay
Sponsored by
About this trial
This is an interventional screening trial for Uterine Cancer
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.
Sites / Locations
- University of Arkansas
- University Hospital CASE Medical Center
- University of Texas
- University of Texas
- Eastern Virginia Medical School
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
P2x7 Assay
Arm Description
Compare assay results with biopsy
Outcomes
Primary Outcome Measures
To determine the accuracy potential of the P2X7 (protein and mRNA levels) for the detection of uterine endometrial cancers in women.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00471120
Brief Title
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
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to protocol deficiencies.
Study Start Date
November 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dick Domanik
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cancer, Endometrial Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
P2x7 Assay
Arm Type
Experimental
Arm Description
Compare assay results with biopsy
Intervention Type
Other
Intervention Name(s)
P2x7 assay
Intervention Description
compare P2X7 assay to biopsy
Primary Outcome Measure Information:
Title
To determine the accuracy potential of the P2X7 (protein and mRNA levels) for the detection of uterine endometrial cancers in women.
Time Frame
Upon review of the assays.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Pinkerton, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205-7199
Country
United States
Facility Name
University Hospital CASE Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9032
Country
United States
Facility Name
University of Texas
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0156
Country
United States
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15269006
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.
Results Reference
background
PubMed Identifier
15459114
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.
Results Reference
background
PubMed Identifier
15728711
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.
Results Reference
background
PubMed Identifier
16624800
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.
Results Reference
background
PubMed Identifier
17035398
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.
Results Reference
background
Learn more about this trial
Feasibility Study: Accuracy of Biomarker in Detection of Endometrial Cancer
We'll reach out to this number within 24 hrs