TerminatedNCT00471120Updated Aug 5, 2015

Feasibility Study: Accuracy of Biomarker in Detection of Endometrial Cancer

An interventional study of P2x7 assay in Uterine Cancer and Endometrial Cancer, sponsored by Dick Domanik. Terminated at 5 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-05.

Sponsored by Dick Domanik · Not applicable, Interventional, and Screening

Why this study was terminated

Study terminated due to protocol deficiencies.

Phase: Not applicable
Study type: Interventional
Enrollment: 20
Allocation: Not applicable
Ages: 18 Years and older
Sex: Female

Study summary

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

Read the 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.

Conditions studied

Uterine Cancer
Endometrial Cancer

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In context

Endometrial Neoplasms

1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.

This study's enrollment of 20 is below the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.

Browse Endometrial Neoplasms studies →

Lead sponsor

This is the only study on the registry with Dick Domanik as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

women scheduled to undergo hysterectomy
ages 18 years and older

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 20 participants (actual)

Study arms

Experimental
P2x7 Assay
Compare assay results with biopsy
Other: P2x7 assay

Interventions

OtherP2x7 assay
compare P2X7 assay to biopsy

What researchers measure

Primary outcomes

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.

Study locations

5 sites

University of Arkansas
Little Rock, Arkansas 72205-7199, United States
University Hospital CASE Medical Center
Cleveland, Ohio 44106, United States
University of Texas
Dallas, Texas 75390-9032, United States
University of Texas
Galveston, Texas 77555-0156, United States
Eastern Virginia Medical School
Norfolk, Virginia 23510, United States

References and documents

Publications

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. PubMed 15269006 ↗
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. PubMed 15459114 ↗
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. PubMed 15728711 ↗
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. PubMed 16624800 ↗
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. PubMed 17035398 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00471120
Lead sponsor: Dick Domanik
Responsible party: Dick Domanik (Scientist, CytoCore, Inc.) — Sponsor-investigator
First posted: May 9, 2007
Start date: Nov 2006
Primary completion: Apr 2007
Completion: Feb 2008
Last update: Aug 5, 2015

Study contacts

Jay Pinkerton, MD

principal investigator · University Hospitals Cleveland Medical Center

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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