Polycystic Ovarian Syndrome (PCOS) Biomarker Evaluation Study

NCT06642831 | Recruiting

• 1 other identifier: 22-114-B
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to validate recently identified biomarkers for the identification of PCOS in adolecent and young adult women.

Conditions

Polycystic Ovarian Syndrome (PCOS)

Keywords

PCOS; biomarker; adolescents

Outcome Measures

Primary Outcomes (1)

• The validation of new potential biomarkers for aid in the diagnoisis of PCOS in adolescent and young adult women

  Baseline

Study Arms (2)

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

Eligibility Criteria

• Age: 15 Years - 25 Years
• Gender Eligibility Details: Subjects who were assigned female at birth and are currently registered as females.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Female subjects age 15-25 years
• Signed written informed consent

You may not qualify if:

• Less than 1 years from onset of menarche
• Use of hormonal contraceptives
• Documented ongoing pregnancy
• Major ovarian abnormalities, including subject with only one ovary, cysts and solid masses \> 2 cm as detected by transvaginal ultrasound
• Malignancy ( documented malignancy, documentation of current radiation therapy or chemotherapy in medical record)

Sponsors & Collaborators

• University Hospital Erlangen: lead
• Roche Diagnostics International AG: collaborator

Study Sites (1)

Department of Obstetrics and Gynecology, University Erlangen Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany

Erlangen, 91054, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Ralf Dittrich, Prof.

  University Hospital Erlangen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Lotz, Dr. med.

CONTACT

+49 9131 85 44023; laura.lotz@uk-erlangen.de

Ralf Dittrich, Prof.

CONTACT

ralf.dittrich@uk-erlangen.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: January 31, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 15, 2024

Record last verified: 2024-04

Locations

DE (1)