In this study we aim to assess the validity of the PriskA algorithm to diagnose PCOS in a pilot study with patients presenting with signs and symptoms of PCOS. The study also aims to collect information on the user experience from the clinicians and…
ID
Source
Brief title
Condition
- Endocrine disorders of gonadal function
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The validity of the PriskA tool to diagnose PCOS, by assessing the sensitivity
and specificity of the risk probabilities of 0.2 and 0.8. Parameters that will
be used:
- Testosterone level in serum (using Elecsys using Cobas 6000)
- SHBG level in serum (using Elecsys using Cobas 6000).
- AMH level in serum (using Elecsys using Cobas 6000).
- LH level in serum (using Elecsys using Cobas 6000)
- FSH level in serum (using Elecsys using Cobas 6000)
- Cycle information
- Age
- BMI
Secondary outcome
A secondary study parameter is to assess the number (percentage) and
characteristics of patients with a PriskA score between 0.2-0.8.
Characteristics will include: menstrual cycle information, age, BMI, serum LH,
serum FSH, serum AMH, serum testosterone, serum SHBG, serum progesterone, serum
estradiol, total follicle count, PCOS phenotype (if applicable), WHO diagnosis
or other endocrinological diagnosis.
Another secondary parameter is the user experience of the PriskA tool. This
will be collected from every user by a questionnaire. Questionnaires will be
collected from every user when he/she completed 20 patients during the study.
Background summary
With a prevalence up to 15%, polycystic ovary syndrome (PCOS) is the most
common endocrine disorder in women of reproductive age. Women with PCOS present
with diverse features, including reproductive features such as irregular
menstrual cycles, subfertility, hirsutism and pregnancy complications,
metabolic features such as obesity, insulin resistance, metabolic syndrome,
pre-diabetes, type 2 diabetes and cardiovascular factors, and psychological
features such as anxiety and depression (2-5). Because of the reproductive,
metabolic and cardiovascular risk factors it is important to screen and inform
these women. However, up to 70% of the affected women remain undiagnosed (7).
In academic hospitals (tertiary care) the diagnosis PCOS will rarely be missed
by gynecologists. However, in peripheral hospitals or for internal medicine
physicians, PCOS and its criteria are less well known.
Therefore, the PCOS risk algorithm (PriskA), a digital tool to use in the
assessment of PCOS in patients with signs and symptoms of PCOS, is developed.
To exclude patients with a WHO I status, the tool exclude women with low
Luteinizing Hormone (LH) and low Follicle-Stimulating Hormone (FSH) in advance.
Women with LH and FSH within the normal range will be used in the algorithm for
further assessment. The algorithm uses clinical data including age, BMI and
information about irregular menstrual cycle in combination with anti-Mullerian
hormone (AMH), testosterone and Sex Hormone Binding Globulin (SHBG) to generate
a risk score ranging from 0-1. Women having a risk score below 0.2 are
considered having a low risk of having PCOS, women with a risk score 0.2-0.8
are considered having a moderate risk of having PCOS and women with a risk
score above 0.8 have a high risk of having PCOS.
Study objective
In this study we aim to assess the validity of the PriskA algorithm to diagnose
PCOS in a pilot study with patients presenting with signs and symptoms of PCOS.
The study also aims to collect information on the user experience from the
clinicians and to provide useful information to support the design of a
validation study.
Study design
This study will be a prospective, mono-center observational pilot study and it
will be conducted at the Department of Reproductive Endocrinology at the
Erasmus University Medical Center Rotterdam, the Netherlands. We estimate that
the study will be completed within one year.
Study burden and risks
Burden associated with participation is the withdrawal of one extra blood
sample during the standardized blood withdrawal that is part of the
standardized screening. Participating in the study will not influence the final
diagnosis or the follow-up of clinical care. There are no risks for the
participants.
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Women with signs and symptoms of PCOS, including: irregular or absent
menstrual cycle, hirsutism or polycystic ovarian morphology who undergoing a
standardized screening (COLA screening)
- Age range 16-45 years
- Sufficient command of the Dutch language
- Signed written informed consent
Exclusion criteria
- Documented ongoing pregnancy
- Malignancy (documented malignancy, documentation of current radiation therapy
or chemotherapy in medical record)
- If transvaginal ultrasound is not possible or it is inappropriate
- Not willing to share clinical data with Roche and Evidencio
- Use of hormonal medication in the past three months, including hormonal IUD
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82155.078.22 |