Polycystic Ovarian Syndrome (PCOS)PHOEBENCT06642831
Polycystic Ovarian Syndrome (PCOS) Biomarker Evaluation Study
An observational study of Polycystic Ovarian Syndrome (PCOS), run by University Hospital Erlangen at 1 site in Germany.
Trial summary
The purpose of the study is to validate recently identified biomarkers for the identification of PCOS in adolecent and young adult women. Read more about this study
- Who is it for?
- Ages 15 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovarian Syndrome (PCOS)
- How many people
- 380 participants
- Where
- 1 siteGermany
- Study dates
- 31 Jan 2023to Mar 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- Female subjects age 15-25 years
- Signed written informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ralf Dittrich, Prof. contact
Germany1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, University Erlangen Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany
Erlangen, 91054
Laura Lotz, Dr, +49 9131 85 44023, laura.lotz@uk-erlangen.de
Ralf Dittrich, Prof, ralf.dittrich@uk-erlangen.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Polycystic Ovarian Syndrome (PCOS)
- Keywords
- PCOS, biomarker, adolescents
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
The validation of new potential biomarkers for aid in the diagnoisis of PCOS in adolescent and young adult women
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start31 Jan 2023
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 380 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital Erlangen
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics International AG
- Responsible party
- Principal investigator, Laura Lotz, University Hospital Erlangen
- Investigators
- Ralf Dittrich, Prof., Principal investigator, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642831
- Sponsor's protocol ID
- 22-114-B
- Acronym
- PHOEBE
- Status last verified
- Apr 2024
- First submitted
- 9 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polycystic Ovarian Syndrome (PCOS) in Human Adolescent and Young Adult Females - Biomarker Evaluation Study (PHOEBE)
- ClinicalTrials.gov ID
- NCT06642831
- Acronym / sponsor ID
- PHOEBE / 22-114-B
- Conditions
- Polycystic Ovarian Syndrome (PCOS)
- Keywords
- PCOS, biomarker, adolescents
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- University Hospital ErlangenUniversity, hospital or other
- Collaborators
- Roche Diagnostics International AG
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to validate recently identified biomarkers for the identification of PCOS in adolecent and young adult women.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Female subjects age 15-25 years
- Signed written informed consent
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The validation of new potential biomarkers for aid in the diagnoisis of PCOS in adolescent and young adult women
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ralf Dittrich, Prof. contact
Ralf Dittrich, Prof. principal investigator
University Hospital Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovarian Syndrome (PCOS), run by University Hospital Erlangen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Lotz, Dr. med. (+49 9131 85 44023, laura.lotz@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The validation of new potential biomarkers for aid in the diagnoisis of PCOS in adolescent and young adult women (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.