NCT01075386

Brief Summary

Endometrial cancer usually begins in the endometrium, which is the tissue lining of the uterus. Endometrial cancer is the most commonly diagnosed gynaecological malignancy in Australia. It affects 1 in 80 Australian women and there are about 1400 new cases and 260 deaths from the disease every year. Most affected women are aged between 50 and 70 years. The purpose of this study is to investigate the possible role of the endocrine system in the regulation of human endometrial cancer. By looking at the laboratory results of people with endometrial cancer and also those without endometrial cancer we hope to gain a better understanding of how endometrial cancer develops and progresses. This may lead to the development of new, effective therapies for endometrial cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2009

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

October 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
7.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

1.8 years

First QC Date

February 23, 2010

Last Update Submit

August 26, 2019

Conditions

Keywords

HysterectomyEndometrial cancerBenignEndocrine systemTissue collection

Study Arms (4)

Grade 2

Patients with Endometrial cancer of Grade 1 differentiation

Benign

Patients without endometrial cancer

Grade 1

Patients with Endometrial cancer of Grade 2 differentiation

Grade 3

Patients with Endometrial cancer of Grade 3 differentiation

Eligibility Criteria

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

Patients with endometrial cancer and patients who are having a hysterectomy for non-cancerous conditions such as fibroids, chronic pelvis pain or abnormal uterine bleeding are eligible for the study

You may qualify if:

  • women aged 18 years or older
  • having a hysterectomy for the treatment of endometrial cancer, fibroids, chronic pelvic pain or abnormal uterine bleeding
  • have provided informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Greenslopes Private Hospital

Greenslopes, Queensland, 4120, Australia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Endometrial tissue

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Chen Chen, MD PhD

    The University of Queensland

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2010

First Posted

February 25, 2010

Study Start

October 1, 2009

Primary Completion

August 1, 2011

Study Completion

December 1, 2018

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations