Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01075386




Registration number
NCT01075386
Ethics application status
Date submitted
23/02/2010
Date registered
25/02/2010
Date last updated
28/08/2019

Titles & IDs
Public title
The Effects of the Endocrine System on Endometrial Cancer
Scientific title
Expression and Function of Ghrelin and Its Receptor, Growth Hormone Secretagogue Receptor TWEAK Protein and Its Receptor Fn14 in Human Endometrial Cancer
Secondary ID [1] 0 0
Endo01
Universal Trial Number (UTN)
Trial acronym
Ghrelin
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2018
Sample size
Target
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment postcode(s) [1] 0 0
4120 - Greenslopes

Funding & Sponsors
Primary sponsor type
Government body
Name
Queensland Centre for Gynaecological Cancer
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Greenslopes Private Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The University of Queensland
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Sullivan and Nicolaides Pathology
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT01075386
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chen Chen, MD PhD
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01075386