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The Effects of the Endocrine System on Endometrial Cancer (Ghrelin)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01075386
Recruitment Status : Completed
First Posted : February 25, 2010
Last Update Posted : August 28, 2019
Sponsor:
Collaborators:
Greenslopes Private Hospital
The University of Queensland
Sullivan and Nicolaides Pathology
Information provided by (Responsible Party):
Queensland Centre for Gynaecological Cancer

Tracking Information
First Submitted Date February 23, 2010
First Posted Date February 25, 2010
Last Update Posted Date August 28, 2019
Actual Study Start Date October 2009
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Effects of the Endocrine System on Endometrial Cancer
Official Title Expression and Function of Ghrelin and Its Receptor, Growth Hormone Secretagogue Receptor TWEAK Protein and Its Receptor Fn14 in Human Endometrial Cancer
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Endometrial tissue
Sampling Method Non-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
Condition Endometrial Cancer
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 26, 2019)
75
Original Estimated Enrollment
 (submitted: February 24, 2010)
40
Actual Study Completion Date December 2018
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia
Removed Location Countries  
 
Administrative Information
NCT Number NCT01075386
Other Study ID Numbers Endo01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Queensland Centre for Gynaecological Cancer
Study Sponsor Queensland Centre for Gynaecological Cancer
Collaborators
  • Greenslopes Private Hospital
  • The University of Queensland
  • Sullivan and Nicolaides Pathology
Investigators
Study Chair: Chen Chen, MD PhD The University of Queensland
PRS Account Queensland Centre for Gynaecological Cancer
Verification Date August 2019