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

30. september 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100

Kontakter og lokationer

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Studiekontakt

Studiesteder

  • Italien
      • Bologna, Italien, 40138
        • Rekruttering
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Bologna 40138
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 sekund til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

2. oktober 2026

Primær færdiggørelse (Anslået)

30. september 2027

Studieafslutning (Anslået)

1. januar 2029

Datoer for studieregistrering

Først indsendt

30. september 2026

Først indsendt, der opfyldte QC-kriterier

30. september 2026

Først opslået (Faktiske)

6. oktober 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • INSL3GNRH

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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.

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

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