INSL3 as a Biomarker to See If Puberty Has Started
Official title: INSL3 as an Early Marker of Pubertal Activation: Evaluation of Its Potential Role as a New Biomarker in the Diagnosis of Central Precocious Puberty and Delayed Puberty.
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT07859787 · Data updated 2026-11-12
Researchers are testing whether a single blood test for INSL3 can tell if a child’s puberty has begun, potentially reducing need for the GnRH stimulation test.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Years to 18 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Status | Recruiting |
| Started | October 2, 2026 |
| Main results expected | September 30, 2027 |
| Study ends | January 1, 2029 |
| Registry record updated | October 6, 2026 |
| Trial ID | NCT07859787 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 0–16 with suspected central precocious puberty or delayed puberty, where baseline INSL3 levels could inform diagnostic evaluation.
✕Probably not a fit
Patients whose pubertal status does not correlate with INSL3 levels or who have conditions that affect gonadal development may not benefit from this biomarker approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study tracks children up to 16 years old who may have central precocious puberty or delayed puberty. It compares basal INSL3 levels, measured from an additional baseline blood sample, with results from the standard GnRH stimulation test and other clinical data. The goal is to see if INSL3 can serve as a simple, noninvasive marker of pubertal activation. If validated, INSL3 testing could streamline diagnosis and lessen reliance on dynamic stimulation testing in pediatric practice.
Why it matters
Potential benefit: If successful, INSL3 testing could provide a quicker, less invasive way to diagnose pubertal onset and reduce the need for the GnRH stimulation test.
How similar studies have gone: Prior research suggests INSL3 is a stable marker of gonadal maturation, but its use as a standalone diagnostic tool for pubertal activation remains to be validated in this setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * Females with suspected DP, defined by the absence of thelarche by 13 years of age. * Written informed consent for study participation and personal data processing provided by the parents/legal guardians, with the assent of the participating minor. Exclusion Criteria: * 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).
Where it's running
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IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Bologna 40138
Bologna, Italy Recruiting
Study contacts
- Study coordinator: Federico Baronio, MD, PhD
- Email: federico.baronio@aosp.bo.it
- Phone: 00390512144816
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.