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| Name | Class |
|---|---|
| Roche Diagnostics International AG | INDUSTRY |
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The purpose of the study is to validate recently identified biomarkers for the identification of PCOS in adolecent and young adult women.
The purpose of the study is to validate potential biomarkers for the aid in the diagnosis of PCOS in adolescent and young adult women in the age range of 15-25 years. Female subjects included in this study will have one visit where clinical data for assessing PCOS will be collected and a blood draw will be performed to collect serum for measurement of parameters relevant to PCOS will be performed. Study subjects that receive a PCOS diagnosis will have two follow up visits for follow up on treatment where additional serum and clinical data will be collected. The first visit will be 3 months after receiving the diagnosis and the second visit 6-12 months after the initial visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with PCOS | Women in the age range of 15-25 years fulfilling the PCOS criteria defined by the International Evidence-based Guideline | ||
| Women without PCOS (controls) | Women in the age range of 15-25 years who are negative for the diagnostic criteria of PCOS according to the International Evidence based guideline |
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| Measure | Description | Time Frame |
|---|---|---|
| The validation of new potential biomarkers for aid in the diagnoisis of PCOS in adolescent and young adult women | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who were assigned female at birth and are currently registered as females.
Adolescent and young adult women aged between the ages of 15 and 25 with and without PCOS who present at the Women's Clinic of the University Hospital Erlangen.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Lotz, Dr. med. | Contact | +49 9131 85 44023 | laura.lotz@uk-erlangen.de | |
| Ralf Dittrich, Prof. | Contact | ralf.dittrich@uk-erlangen.de |
| Name | Affiliation | Role |
|---|---|---|
| Ralf Dittrich, Prof. | University Hospital Erlangen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, University Erlangen Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany | Recruiting | Erlangen | 91054 | Germany |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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Serum
|
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |