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INSL3 as a Biomarker of Pubertal Activation: Role in Evaluating Precocious and Delayed Puberty (INSL3GNRH)

30. september 2026 oppdatert av: Federico Baronio, IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

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.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

Diagnosing the exact onset of puberty, especially in its early stages, is a clinical challenge. Currently, the gonadotropin-releasing hormone (GnRH) stimulation test is the gold standard for evaluating hypothalamic-pituitary-gonadal (HPG) axis activation. However, this test is invasive, time-consuming, expensive, and may have limited sensitivity during the very early phases of Central Precocious Puberty (CPP) or Delayed Puberty (DP).

INSL3 is produced constitutively by Leydig cells in males and theca cells of growing antral follicles in females. Unlike other hormones which are secreted with acute and pulsatile patterns, INSL3 exhibits minimal circadian variation and reflects the continuous maturation of gonadal tissues.

The purpose of this study is to evaluate INSL3 as an early marker of pubertal activation. By correlating basal INSL3 levels, measured via ELISA, with the outcomes of standard GnRH tests and other clinical parameters, the investigators hope to determine if INSL3 can accurately predict HPG axis activation. Ultimately, validating this biomarker could lead to a simpler, single-sample diagnostic approach, reducing the burden of dynamic stimulation testing in pediatric practice.

Studietype

Observasjonsmessig

Registrering (Antatt)

100

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Italia
      • Bologna, Italia, 40138
        • Rekruttering
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Bologna 40138
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

1 sekund til 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Suspected Central Precocious Puberty (CPP)

Pediatric patients (males under 9 years, females under 8 years) with clinical signs of early pubertal onset, undergoing a standard GnRH stimulation test.
Suspected Delayed Puberty (DP)

Pediatric patients (males 14 years and older, females 13 years and older) with absent signs of puberty, undergoing a standard GnRH stimulation test.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Baseline INSL3 Concentration as a Predictor of GnRH Test Outcome
Tidsramme: Baseline (prior to GnRH test administration)

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.
Baseline (prior to GnRH test administration)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Diagnostic Accuracy of Combined INSL3 and Clinical Parameters
Tidsramme: Baseline

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.
Baseline
Correlation Between INSL3 and Pubertal Development Parameters
Tidsramme: Baseline

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.
Baseline

Samarbeidspartnere og etterforskere

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Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

2. oktober 2026

Primær fullføring (Antatt)

30. september 2027

Studiet fullført (Antatt)

1. januar 2029

Datoer for studieregistrering

Først innsendt

30. september 2026

Først innsendt som oppfylte QC-kriteriene

30. september 2026

Først lagt ut (Faktiske)

6. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • INSL3GNRH

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data (IPD) underlying the results of this study will be shared upon reasonable request to the Principal Investigator. The shared data will include clinical, auxological, biochemical, and instrumental parameters used for the analyses, provided in a completely anonymous format to protect participant privacy.

IPD-delingstidsramme

Following the publication of the study results.

Tilgangskriterier for IPD-deling

Data will be shared upon reasonable request submitted to the Principal Investigator.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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