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ID
Source
Brief title
Health condition
Endometrial cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
To compare hormone levels and inflammatory markers before and after BSO in obese and non-obese subjects.
Secondary outcome
To compare the effect of fat distribution and etiology on changes in hormone levels and inflammatory markers due to BSO in obese and non-obese subjects as well as the effect of BSO on menopausal complaints.
Background summary
The impact of BMI and fat distribution (subcutaneous vs. visceral) on hormone levels and inflammation is not clear. Yet, understanding these interactions in general is highly relevant, and in particular for better understanding and treatment of endometrial cancer (EC) in increasingly obese patients. Standard surgical treatment of EC and of adnexal masses gives access to both the subcutaneous and the visceral adipose tissue, and facilitates to study these important relations. We hypothesize that BMI, the type of fat distribution, and possibly the underlying illness significantly influence the change in hormone levels, and systemic inflammation levels after bilateral salpingo-oophorectomy (BSO). In EC patients , systemic inflammation markers are expected to be higher compared to controls. Also, we expect the ratio of visceral:subcutaneous fat to be higher in these women, as visceral fat tissue is considered to be more metabolic active. Finally, we expect that BSO in obese women result in only slight decrease in estrogen levels.
Study objective
We hypothesize that BMI, the type of fat distribution, and possibly the underlying illness significantly influence the change in hormone levels, and systemic inflammation levels after bilateral salpingo-oophorectomy (BSO). In EC patients , systemic inflammation markers are expected to be higher compared to controls. Also, we expect the ratio of visceral:subcutaneous fat to be higher in these women, as visceral fat tissue is considered to be more metabolic active. Finally, we expect that BSO in obese women result in only slight decrease in estrogen levels.
Study design
Pre-operation, during operation, 6 weeks after operation
Intervention
Preoperatively: All included subjects are requested to consent for blood sample analysis, undergoing CT-scan and fill in three questionnaires. During surgery, fat tissue and (in cases) tumour tissue will be collected. Six weeks after surgery blood will be obtained from all subjects once more and one questionnaire repeated.
Inclusion criteria
- CASES (n=80): - pre- and perimenopausal BMI ≥35 (n=20)
- pre- and perimenopausal BMI 18-25 (n=20)
- postmenopausal BMI ≥35 (n=20)
- postmenopausal BMI 18-25(n=20)
Exclusion criteria
- Other malignancy <5 years prior to inclusion, except basal cell carcinoma
- Use of systemic hormonal therapy <3 months
- Insufficient understanding of the Dutch language
- Subjects not allowed to undergo CT-scan
- Women (cases as well as controls) with BMI between 25.1-34.9
- Women who are expected to be offered HRT after surgery
CONTROLS (n=80): - Pre- and perimenopausal BMI ≥35 (n=20)
- Age >40 years
- pre- and perimenopausal BMI <25 (n=20)
- postmenopausal BMI ≥35 (n=20)
- postmenopausal BMI 18-25(n=20)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9622 |
| Other | METC AZM/UM : METC 21-011 |