Endometrial CancerGhrelinNCT01075386
The Effects of the Endocrine System on Endometrial Cancer
An observational study of Endometrial Cancer, run by Queensland Centre for Gynaecological Cancer at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- How many people
- 75 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2009to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expression and Function of Ghrelin and Its Receptor, Growth Hormone Secretagogue Receptor TWEAK Protein and Its Receptor Fn14 in Human Endometrial Cancer
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.
- Conditions
- Endometrial Cancer
- Keywords
- Hysterectomy, Endometrial cancer, Benign, Endocrine system, Tissue collection
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionAug 2011
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queensland Centre for Gynaecological Cancer
- Sponsor type
- Other government
- Collaborators
- Greenslopes Private Hospital, The University of Queensland, Sullivan Nicolaides Pathology
- Responsible party
- Sponsor
- Investigators
- Chen Chen, MD PhD, Study chair, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075386
- Sponsor's protocol ID
- Endo01
- Acronym
- Ghrelin
- Status last verified
- Aug 2019
- First submitted
- 23 Feb 2010
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression and Function of Ghrelin and Its Receptor, Growth Hormone Secretagogue Receptor TWEAK Protein and Its Receptor Fn14 in Human Endometrial Cancer
- ClinicalTrials.gov ID
- NCT01075386
- Acronym / sponsor ID
- Ghrelin / Endo01
- Conditions
- Endometrial Cancer
- Keywords
- Hysterectomy, Endometrial cancer, Benign, Endocrine system, Tissue collection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Queensland Centre for Gynaecological CancerOther government
- Collaborators
- Greenslopes Private Hospital, The University of Queensland, Sullivan Nicolaides Pathology
- Study start
- Oct 2009 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 25 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Chen, MD PhD study chair
The University of Queensland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by Queensland Centre for Gynaecological Cancer at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.