Polycystic Ovarian Syndrome (PCOS) Biomarker Evaluation Study (PHOEBE)

October 14, 2024 updated by: Laura Lotz, University Hospital Erlangen

Polycystic Ovarian Syndrome (PCOS) in Human Adolescent and Young Adult Females - Biomarker Evaluation Study (PHOEBE)

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

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

380

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Erlangen, Germany, 91054
        • Recruiting
        • Department of Obstetrics and Gynecology, University Erlangen Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The validation of new potential biomarkers for aid in the diagnoisis of PCOS in adolescent and young adult women
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Erlangen

Collaborators

Roche Diagnostics International AG

Investigators

  • Principal Investigator: Ralf Dittrich, Prof., University Hospital Erlangen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

October 9, 2024

First Submitted That Met QC Criteria

October 14, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 14, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-114-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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