NCT02724501

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
217

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2000

Completed
10.9 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

11.5 years

First QC Date

February 11, 2011

Last Update Submit

March 24, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of endometrial cancer patients with inactivated PTEN tumor suppressor gene

    Determining the association of PTEN inactivation and PKB expression, mutation of p53, microsatellite instability and progesterone receptor status in endometrial cancer

    6 months

Interventions

questionnaireBEHAVIORAL

Using questionnaire to obtain patient's medical and family history of cancer.

Using Samples obtained to produce summary statistics on the tumour markers

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Endometrial Cancer

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Anthony Fyles, MD

    Princess Margaret Hospital, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2011

First Posted

March 31, 2016

Study Start

April 1, 2000

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations