Pelvic and peripheral steroid levels.

Pelvic versus peripheral steroid levels in postmenopausal patients with and without endometrial hyperplasia or carcinoma.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26460

Enrollment

Registered

2010-05-28

Start date

2010-07-01

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Steroid hormone serum-levels Endometrial Hyperplasia Endometrial Carcinoma Postmenopausal women Serumwaarden steroidhormonen Endometrium hyperplasie Edometium carcinoom Postmenopausale vrouwen

Interventions

There will be three subgroups: 1. Postmenopausal women with endometrial hyperplasia

2. Postmenopausal women with endometrial carcinoma

3. Controls (postmenopausal women who undergo an abdominal hysterectomy for other reasons). We take 3 blood samples (2-3 mL) during surgery: 1. One sample of the infundibolopelvic vein

2. One sample of the parauterine vein

3. One sample of through the intravenous infusion. The steroid concentrations (estrogens, progesterone, androgens) in these samples will be compared within patients and between different patient grou

Eligibility

Inclusion criteria

Inclusion criteria: All postmenopausal women planned to undergo an abdominal hysterectomy with bilateral salpingo-oophorectomy. Patients must meet the following criteria: 1. Have at least one ovary before entering the study; 2. Are willing to consent to the collection and storage of blood for this study; 3. Signed informed consent form according to national/local regulations.

Exclusion criteria

Exclusion criteria: 1. Patients with known abnormalities in the steroid metabolism; 2. Patients who receive hormone replacement therapy; 3. Patients with any disorder making it impossible to give informed consent.

Design outcomes

Secondary

Measure	Time frame
Body Mass Index and the relation with steroid-hormone levels.	—

Primary

Measure	Time frame
Serum estrogen, progesterone and androgen levels will be measured in the bloodsamples, with a standard and validated radioimmunoassay (RIA) as used by the clinical chemistry lab of the MUMC. The final pathologic outcome (presence of endometrial cancer, hyperplasia or normal endometrium) will be verified on routine formalin fixed paraffin embedded tissue in the clinical pathology lab. Steroid levels will be correlated with pathological findings.	—

Measure

Time frame

Serum estrogen, progesterone and androgen levels will be measured in the bloodsamples, with a standard and validated radioimmunoassay (RIA) as used by the clinical chemistry lab of the MUMC. The final pathologic outcome (presence of endometrial cancer, hyperplasia or normal endometrium) will be verified on routine formalin fixed paraffin embedded tissue in the clinical pathology lab. Steroid levels will be correlated with pathological findings.

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Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)