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Steroïde hormonen en eaLocal steroid production (intracrinology) in endometriosis – inter & intra patient variabilityndometriose

Local steroid production (intracrinology) in endometriosis – inter & intra patient variability

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON20678
Enrollment
400
Registered
2018-09-11
Start date
2019-09-09
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

endometriosis local estrogen metabolism intracrinology

Interventions

Blood (10 mL), urine (10 mL) and peritonel fluid sampling (10 mL) prior to standard care (e.g. surgery, medical treatment). Completing a questionnaire about life-style. Obtaining an eutopic endometria

Sponsors

Maastricht University Medical Centre (azM)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Clinical data (via a case report form) and epidemiological, life style and symptoms data (via a questionnaire) will be collected prospectively. Blood samples will be taken before treatment. During surgery endometrial and endometriosis biopsies will be collected. Serum and tissue will be analysed for the steroid profile (LCMS). Biopsies will be assessed for the levels of the enzymes involved in the local estrogen generation. Steroid metabolism data will be correlated with clinical characteristics and symptomatology in each subject.

Secondary

MeasureTime frame
non applicable

Contacts

Public ContactAndrea Romano

Dept. Obstetrics and Gynaecology GROW-School for Oncology and Developmental Biology Maastricht University Medical Centre P. Debyelaan 25

a.romano@maastrichtuniversity.nl+31 (0)43 3881286

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)