Ignite Creation Date:
2024-05-06 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05785507
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2023-03-01
Brief Title:
PriskA Pilot Study
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
A Pilot Study to Test the PCOS Risk Algorithm PriskA
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background of the study
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 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 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 02 are considered having a low risk of having PCOS women with a risk score 02-08 are considered having a moderate risk of having PCOS and women with a risk score above 08 have a high risk of having PCOS
Objective of the study
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 population
Women with symptoms of PCOS who are referred to the Department of Reproductive Endocrinology at the Erasmus University Medical Center Rotterdam and are undergoing a standardized screening COLA screening which stands for menstrual Cycle problems Oligomenorrhea and Amenorrhea The COLA screening is part of standard clinical care Women with one or more symptoms of PCOS will be included in the study Women who eventually getting the diagnosis PCOS by standard screening will be labelled as cases and women who have one PCOS symptom and did not get the diagnosis PCOS will be labelled as controls
Primary study parametersoutcome of the study
The validity of the PriskA tool to diagnose PCOS by assessing the sensitivity and specificity of the risk probabilities of 02 and 08Parameters 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 study parametersoutcome of the study
A secondary study parameter is to assess the number percentage and characteristics of patients with a PriskA score between 02-08 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 used when heshe completed 20 patients during the study
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 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 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 02 are considered having a low risk of having PCOS women with a risk score 02-08 are considered having a moderate risk of having PCOS and women with a risk score above 08 have a high risk of having PCOS
Objective of the study
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 population
Women with symptoms of PCOS who are referred to the Department of Reproductive Endocrinology at the Erasmus University Medical Center Rotterdam and are undergoing a standardized screening COLA screening which stands for menstrual Cycle problems Oligomenorrhea and Amenorrhea The COLA screening is part of standard clinical care Women with one or more symptoms of PCOS will be included in the study Women who eventually getting the diagnosis PCOS by standard screening will be labelled as cases and women who have one PCOS symptom and did not get the diagnosis PCOS will be labelled as controls
Primary study parametersoutcome of the study
The validity of the PriskA tool to diagnose PCOS by assessing the sensitivity and specificity of the risk probabilities of 02 and 08Parameters 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 study parametersoutcome of the study
A secondary study parameter is to assess the number percentage and characteristics of patients with a PriskA score between 02-08 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 used when heshe completed 20 patients during the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None