INSL3 as a Biomarker of Pubertal Activation: Role in Evaluating Precocious and Delayed Puberty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-18
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
About this trial
This is an observational study in children up to 16 years old who are suspected of having central precocious puberty or delayed puberty. The main questions it aims to answer are:
* Can the level of insulin-like peptide 3 (INSL3) predict if a child's puberty has truly started? * Can this marker help reduce the need for more complex and invasive tests?
Participants will:
* Give one extra blood sample just before starting the standard gonadotropin-releasing hormone (GnRH) stimulation test (during the baseline blood draw). * Have this extra sample used to measure the INSL3 hormone. * Complete the rest of the GnRH test as prescribed by their doctor.
Researchers will compare the INSL3 hormone levels in children who have a positive GnRH test to those who have a negative test. This will help researchers learn if INSL3 can be used as a new, simple tool to diagnose early or delayed puberty.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 0 and 16 years at the time of enrollment.
Males with suspected Central Precocious Puberty (CPP), defined by a testicular volume ≥4 mL before 9 years of age.
Females with suspected CPP, defined by the onset of thelarche before 8 years of age.
Males with suspected Delayed Puberty (DP), defined by testicular volume <4 mL by 14 years of age.
Disqualifiers
Presence of congenital or acquired conditions known to primarily alter pubertal development or gonadal function, regardless of HPG axis physiology (e.g., disorders of sex development, anorchia, previous ovariectomy, uncorrected bilateral cryptorchidism, previous iatrogenic gonadotoxicity).
Primary endocrine diseases interfering with hypothalamic-pituitary-gonadal axis regulation (e.g., congenital hypogonadotropic hypogonadism, panhypopituitarism).
Use of hormonal therapies or drugs capable of modifying gonadal function or the response to the GnRH test (e.g., exogenous sex steroids, androgens/anabolic steroids).
Trial population
Pediatric patients of both sexes, aged 0 to 16 years, who are followed for suspected Central Precocious Puberty (CPP) or suspected Delayed Puberty (DP) at the Pediatric Endocrinology Unit of the IRCCS Azienda Ospedaliero-Universitaria of Bologna. These patients must have a clinical indication to undergo a standard GnRH stimulation test as part of their routine diagnostic workup for pubertal evaluation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: Suspected Central Precocious Puberty (CPP)
Group B: Suspected Delayed Puberty (DP)
Trial outcomes
Primary outcomes
1
Baseline INSL3 Concentration as a Predictor of GnRH Test Outcome
Assessment of baseline Insulin-like peptide 3 (INSL3) levels (measured in pg/ml) and their association with the gonadotropin response to the standard GnRH stimulation test (evaluated by peak LH, peak FSH in mU/ml, and LH/FSH ratio) to determine Hypothalamic-Pituitary-Gonadal (HPG) axis activation in patients with suspected precocious or delayed puberty.
Time frame
Baseline (prior to GnRH test administration)Secondary outcomes
1
Diagnostic Accuracy of Combined INSL3 and Clinical Parameters
Evaluation of whether integrating baseline INSL3 (pg/ml) with other clinical and laboratory parameters (bone age in years, uterine longitudinal diameter in cm and volume in ml, basal LH/FSH in mU/ml, estradiol in pg/ml, and testosterone in ng/ml) improves the ability to distinguish patients with a positive GnRH test from those with a negative test.
Time frame
Baseline2
Correlation Between INSL3 and Pubertal Development Parameters
Assessment of the correlation between baseline INSL3 levels (pg/ml) and key physiological parameters of pubertal development, including bone age, baseline gonadotropins, sex steroids, and, in females, uterine dimensions.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov