NCT00471120

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

August 5, 2015

Status Verified

August 1, 2015

Enrollment Period

5 months

First QC Date

May 7, 2007

Last Update Submit

August 3, 2015

Conditions

Uterine CancerEndometrial Cancer

Outcome Measures

Primary Outcomes (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.

Study Arms (1)

P2x7 Assay

EXPERIMENTAL

Compare assay results with biopsy

Other: P2x7 assay

Interventions

P2x7 assayOTHER

compare P2X7 assay to biopsy

P2x7 Assay

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women scheduled to undergo hysterectomy
  • ages 18 years and older

You may not qualify if:

  • pregnant women
  • students or employees under the direct supervision on the investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Arkansas

Little Rock, Arkansas, 72205-7199, United States

Location

University Hospital CASE Medical Center

Cleveland, Ohio, 44106, United States

Location

University of Texas

Dallas, Texas, 75390-9032, United States

Location

University of Texas

Galveston, Texas, 77555-0156, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23510, United States

Location

Related Publications (5)

  • 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.

    PMID: 15269006BACKGROUND

  • 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.

    PMID: 15459114BACKGROUND

  • 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.

    PMID: 15728711BACKGROUND

  • 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.

    PMID: 16624800BACKGROUND

  • 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.

    PMID: 17035398BACKGROUND

MeSH Terms

Conditions

Uterine NeoplasmsEndometrial Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Jay Pinkerton, MD

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Scientist

Study Record Dates

First Submitted

May 7, 2007

First Posted

May 9, 2007

Study Start

November 1, 2006

Primary Completion

April 1, 2007

Study Completion

February 1, 2008

Last Updated

August 5, 2015

Record last verified: 2015-08

Locations

US(5)