Endometriosis N80
Conditions
Interventions
Group 1: Endometriosis patients (premenopausal patients with suspected endometriosis or histologically confirmed endometriosis with or without a confirmed diagnosis of ovarian cancer/endometrial cance
Time point 1: Preoperative (before surgery)
Completion of a clinical questionnaire based on the EPHect EPQ-SG developed by the World Endometriosis Research Foundation (WERF), covering pain perception,
in exceptional cases, a study-specific venipuncture is performed). Collection of urine and stool samples where applicable.
Time point 2: Intraoperative (during laparoscopic surgery)
Collection of tiss
Time point 1: Preoperative (b
Sponsors
Department für Frauengesundheit am Universitätsklinikum Tübingen
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Cohort 1: Endometriosis patients Inclusion criteria: • Premenopausal patients with suspected endometriosis or histologically confirmed endometriosis with or without a confirmed diagnosis of ovarian cancer/endometrial cancer • Biological sex: women • Age: 18 years or older with perimenopause (no upper age limit for patients with regular cycles) • Patients capable of giving consent • Written informed consent for prospective sample collection • Written broad consent for samples already stored Cohort 2: Controls Inclusion criteria: • Premenopausal patients without suspected endometriosis or histologically confirmed endometriosis • Biological sex: women • Age: 18 years or older with perimenopause (no upper age limit for regular cycles) • Patients capable of giving consent • Written informed consent for prospective sample collection • Written broad consent for samples already stored
Exclusion criteria
Exclusion criteria: Cohort 1: Endometriosis patients Exclusion criteria: • Expected lack of patient compliance or inability of the patient to understand the meaning and purpose of the clinical trial (for prospective sample collection) • Lack of patient consent/lack of broad consent • Known malignancy other than ovarian cancer/endometrial cancer • Immunosuppression • Pregnancy and breastfeeding • Incomplete medical history data (including hormonal (pre)medication) Cohort 2: Controls Exclusion criteria: • Expected lack of patient compliance or inability of the patient to understand the meaning and purpose of the clinical trial (for prospective sample collection) • Lack of patient consent/broad consent • Known malignancy • Immunosuppression • Pregnancy and breastfeeding • Incomplete medical history data (including hormonal (pre-)medication)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characterization of endometriotic lesions using metabolomics/lipidomics, microbiome analysis, spectral imaging (HSI, MALDI, Raman), and immunoprofiling. During diagnostic/therapeutic surgery and routine blood sampling over 36 months. Analysis of tissue, blood, urine, stool, ascites, and peritoneal fluid. | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of metabolic pathways with lesion type, location, and severity Identification of immune target molecules (NKG2DL, HLA-presented antigens) for potential immunotherapies Pain assessment (pre-, post-operative, and follow-up) using the WERF EPHect questionnaire Characterization of the interaction of endometrial cells with peritoneal cells Influence of the menstrual cycle on lesion reactivity Evaluation of potential biomarkers in serum and peritoneal fluid | — |
Countries
Germany
Contacts
Public ContactBernhard Krämer
Department für Frauengesundheit am Universitätsklinikum Tübingen
Outcome results
None listed