Endometrial CancerFETCHNCT02226302
Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer
An observational study of Endometrial Cancer, run by Queensland Centre for Gynaecological Cancer at 2 sites in Australia.
Trial summary
The objective is to develop an organotypic model to assess the effects of obesity on the expression and methylation status of estrogen-responsive genes in endometrial cancer. Omental fat samples will be removed from participants during surgery and these fat samples will be used in laboratory analyses. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Endometrial Cancer
- How many people
- 16 participants
- Where
- 2 sitesAustralia
- Study dates
- Jul 2014to Aug 2021
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 12 female patients undergoing surgery for pre-existent conditions will be recruited for this study. The groups will include 6 patients with a BMI < 30 kg/m2 and 6 patients with a BMI ≥ 35 kg/m2. In addition 4 males patients will be recruited to assess responses from patients with low levels of serum estradiol.
Who may be able to join
- Age 18-80 years
- Any patient having abdominal surgery (Laparoscopic or open technique) for benign conditions
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patients must have adequate:
- Hematologic function: Neutrophils ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L
- Renal function: serum creatinine ≤ ULN or estimated glomerular filtration rate (eGFR) [CKD-EPI Formula] ≥ 60 mL/min
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- Hepatic function: serum bilirubin ≤ 1.5 x ULN and AST ≤ 2.5 x ULN and ALT≤ 2.5 x ULN
- Physically able to undergo surgery
- Written informed consent
Who cannot join
- Confirmed gynaecological malignancy
- Contraindications and/or unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
- Patients who are pregnant or lactating
- Serious illness or medical condition but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (patients with stable AF are eligible), or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with disseminated intra-peritoneal malignancy or suspected ovarian cancer
- HIV positive
- Previous bariatric surgery
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Queen Elizabeth II Jubilee Hospital
Coopers Plains, Queensland, 4108
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
About this study
The objective is to develop an organotypic model to assess the effects of obesity on the expression and methylation status of estrogen-responsive genes in endometrial cancer. Omental fat samples will be removed from participants during surgery and these fat samples will be used in laboratory analyses.
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial cancer, Obesity
- Medical subject headings
- Endometrial Neoplasms, Obesity
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 |
|---|---|---|
| Female Group 2 | Females with BMI >30 kg/m2 who are having a hysterectomy for benign conditions | |
| Females Group 1 | Females with BMI <30 kg/m2 who are having a hysterectomy for benign conditions | |
| Males | 2 males with BMI <30 kg/m2 and 2 males with BMI >30 kg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify estrogen-response genes in endometrial cancer
Omental fat will be collected from 6 lean patients, 6 obese patients and 4 controls (male patients) and co-cultured with endometrial cancer cell lines
Measured: Baseline
Secondary outcomes (1)
Examine how expression of estrogen response genes are altered in obesity
Compare gene response in tissue from lean and obese individuals
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2018
- Study completionAug 2021
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queensland Centre for Gynaecological Cancer
- Sponsor type
- Other government
- Collaborators
- Queensland Institute of Medical Research, Royal Brisbane and Women's Hospital
- Responsible party
- Sponsor
- Investigators
- Donal Brennan, Principal investigator, Queensland Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226302
- Sponsor's protocol ID
- FETCH
- Acronym
- FETCH
- Status last verified
- Sep 2021
- First submitted
- 11 Jun 2014
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer
- ClinicalTrials.gov ID
- NCT02226302
- Acronym / sponsor ID
- FETCH / FETCH
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial cancer, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Queensland Centre for Gynaecological CancerOther government
- Collaborators
- Queensland Institute of Medical Research, Royal Brisbane and Women's Hospital
- Study start
- Jul 2014 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 27 Aug 2014 (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.
The objective is to develop an organotypic model to assess the effects of obesity on the expression and methylation status of estrogen-responsive genes in endometrial cancer. Omental fat samples will be removed from participants during surgery and these fat samples will be used in laboratory analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Female Group 2 | – | –Females with BMI >30 kg/m2 who are having a hysterectomy for benign conditions |
| Females Group 1 | – | –Females with BMI <30 kg/m2 who are having a hysterectomy for benign conditions |
| Males | – | –2 males with BMI <30 kg/m2 and 2 males with BMI >30 kg/m2 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 12 female patients undergoing surgery for pre-existent conditions will be recruited for this study. The groups will include 6 patients with a BMI < 30 kg/m2 and 6 patients with a BMI ≥ 35 kg/m2. In addition 4 males patients will be recruited to assess responses from patients with low levels of serum estradiol.
Key inclusion criteria (9 listed)
- Age 18-80 years
- Any patient having abdominal surgery (Laparoscopic or open technique) for benign conditions
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patients must have adequate:
- Hematologic function: Neutrophils ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L
Key exclusion criteria (7 listed)
- Confirmed gynaecological malignancy
- Contraindications and/or unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
- Patients who are pregnant or lactating
- Serious illness or medical condition but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (patients with stable AF are eligible), or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with disseminated intra-peritoneal malignancy or suspected ovarian cancer
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
Identify estrogen-response genes in endometrial cancer
Time frame: Baseline
Omental fat will be collected from 6 lean patients, 6 obese patients and 4 controls (male patients) and co-cultured with endometrial cancer cell lines
1 secondary outcome
Examine how expression of estrogen response genes are altered in obesity
Time frame: Baseline
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 9 Sep 2021.
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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.
Donal Brennan principal investigator
Queensland Health
2 sites 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 2 sites 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 9 inclusion and 7 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 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does the primary outcome measure?
Identify estrogen-response genes in endometrial cancer (time frame: Baseline). It is what the study was designed to measure, not a finding.
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 9 Sep 2021.