ocal steroid production (intracrinology) in endometriosis - inter & intra patient variability
- Conditions
- 10016417endometriosis
- Registration Number
- NL-OMON55550
- Lead Sponsor
- niversitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 400
Cases:
- Being older than 18 year
- Diagnosis of endometriosis (laparoscopically confirmed)
- Being scheduled for elective laparoscopic (or laparotomy) surgery for
endometriosis
- Not taking hormonal medications in the previous three months
- Subjects must have signed an approved informed consent, Controls:
- Being older than 18 year
- Being premenopausal
- Having no prior diagnosis of endometriosis
- Not taking hormonal medications in the previous three months
- Being scheduled for any gynaecological surgery like for tubal ligation, for a
benign uterine disease, for diagnosis, for laparoscopic hysterectomy and
bilateral adnexectomy
- Subjects must have signed an approved informed consent
Cases:
- Being younger than 18 year
- Diagnosis of atypical hyperplasia, other types of cancer
- Previous diagnosis of endometrial carcinoma
- Being under hormonal medication during the three months preceding the sampling
- Pregnancy
- Inability to approve the informed consent form, Controls:
- Being younger than 18 year
- Being diagnosed with a benign ovarian diseases
- Being diagnosed with any malignancy
- Previous diagnosis of endometriosis
- Being under hormonal medication during the three months preceding the sampling
- Pregnancy
- Inability to approve the informed consent form
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Clinical data (via a case report form) and epidemiological data (via a<br /><br>questionnaire) and urine will be collected prospectively. Blood samples will be<br /><br>taken before treatment. During surgery endometrial, endometriosis and<br /><br>peritoneal biopsies will be collected. Serum and tissue will be analysed for<br /><br>the steroid profile (LCMS). Biopsies will be assessed for the levels of the<br /><br>enzymes involved in the local estrogen generation</p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable</p><br>