Studies of the Tumour Suppressor Gene PTEN - Endometrial Cancer

Completed

• Conditions: Endometrial Neoplasms

• Registration Number: NCT02724501
• Lead Sponsor: University Health Network, Toronto

Brief Summary

This project seeks to understand the role of the PTEN tumour suppressor gene in endometrial cancer (tumours of the uterine lining), the most common gynecologic cancer in the developed world. The studies in this program span the spectrum from fruit flies to humans, as part of a synergistic partnership that will significantly enhance our understanding of the molecular genetic events involved in the development and progression of endometrial cancer. The discovery of new targets for therapy, and the ability to evaluate these in subsequent clinical trials is a significant strength of this scientific interaction, which may result in cures for patients with primary and relapse endometrial cancer and prevention of this cancer in women who are at high risk.

Detailed Description

PTEN is a critical module that regulates effects of sex hormones on the growth and apoptosis of endometrial cells; and plays an important role in the pathogenesis of subgroups of endometrial cancers, their biologic behaviour and responses to therapeutic agents. Furthermore, mutational inactivation of the PTEN gene can serve as an independent molecular marker that can predict relapse and survival in endometrial cancer. The prognostic effects of PTEN may also be modulated by other tumour suppressor gene losses including P53 mutations, by hormone receptor status, and microsatellite instability.

Study Timeline

• Study Start: 2000-04
• Study First Submitted: 2011-02-11
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-24
• Last Update Submitted: 2016-03-24
• Study First Posted: 2016-03-31
• Last Update Posted: 2016-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 217

Inclusion Criteria

• Age 18 and older
• patients who had a hysterectomy
• patient able to provide consent and complete questionnaire

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of endometrial cancer patients with inactivated PTEN tumor suppressor gene	6 months	Determining the association of PTEN inactivation and PKB expression, mutation of p53, microsatellite instability and progesterone receptor status in endometrial cancer

Trial Locations

Locations (1)

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada