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…
ID
Bron
Verkorte titel
Aandoening
Endometrial cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To compare hormone levels and inflammatory markers before and after BSO in obese and non-obese subjects.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Pre-operation, during operation, 6 weeks after operation
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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)
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL9622 |
Ander register | METC AZM/UM : METC 21-011 |