[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659090":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":25,"studyPopulation":26,"armGroups":27,"interventions":21,"overallOfficials":21,"centralContacts":34,"locations":40,"responsibleParty":56,"collaborators":21,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":21,"studyType":74,"phases":21,"briefSummary":75,"conditions":76,"keywords":21,"overallStatus":43,"whyStopped":21,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Baseline INSL3 Concentration as a Predictor of GnRH Test Outcome","Assessment of baseline Insulin-like peptide 3 (INSL3) levels (measured in pg\u002Fml) and their association with the gonadotropin response to the standard GnRH stimulation test (evaluated by peak LH, peak FSH in mU\u002Fml, and LH\u002FFSH ratio) to determine Hypothalamic-Pituitary-Gonadal (HPG) axis activation in patients with suspected precocious or delayed puberty.","Baseline (prior to GnRH test administration)",[14,18],{"measure":15,"description":16,"timeFrame":17},"Diagnostic Accuracy of Combined INSL3 and Clinical Parameters","Evaluation of whether integrating baseline INSL3 (pg\u002Fml) with other clinical and laboratory parameters (bone age in years, uterine longitudinal diameter in cm and volume in ml, basal LH\u002FFSH in mU\u002Fml, estradiol in pg\u002Fml, and testosterone in ng\u002Fml) improves the ability to distinguish patients with a positive GnRH test from those with a negative test.","Baseline",{"measure":19,"description":20,"timeFrame":17},"Correlation Between INSL3 and Pubertal Development Parameters","Assessment of the correlation between baseline INSL3 levels (pg\u002Fml) and key physiological parameters of pubertal development, including bone age, baseline gonadotropins, sex steroids, and, in females, uterine dimensions.",null,{"allocation":21,"interventionModel":21,"interventionModelDescription":21,"primaryPurpose":21,"observationalModel":23,"timePerspective":24,"maskingInfo":21},"COHORT","PROSPECTIVE","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).\n\nINSL3 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.\n\nThe 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.","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.",[28,31],{"label":29,"type":21,"description":30,"interventionNames":21},"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.",{"label":32,"type":21,"description":33,"interventionNames":21},"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.",[35],{"name":36,"role":37,"phone":38,"phoneExt":21,"email":39},"Federico Baronio, MD, PhD","CONTACT","00390512144816","federico.baronio@aosp.bo.it",[41],{"facility":42,"status":43,"city":44,"state":21,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Bologna 40138","RECRUITING","Bologna","40138","Italy","IT",{"type":49,"coordinates":50},"Point",[51,52],11.33875,44.49381,{"lat":52,"lon":51},[55],{"name":36,"role":37,"phone":38,"phoneExt":21,"email":39},{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Federico Baronio","MD","100659090","insl3-as-a-biomarker-of-pubertal-activation-role-in-evaluating-precocious-and-delayed-puberty-100659090",false,"NCT07859787","INSL3 as a Biomarker of Pubertal Activation: Role in Evaluating Precocious and Delayed Puberty","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.","INSL3GNRH","Inclusion Criteria:\n\n* Age between 0 and 16 years at the time of enrollment.\n* Males with suspected Central Precocious Puberty (CPP), defined by a testicular volume ≥4 mL before 9 years of age.\n* Females with suspected CPP, defined by the onset of thelarche before 8 years of age.\n* Males with suspected Delayed Puberty (DP), defined by testicular volume \\\u003C4 mL by 14 years of age.\n* Females with suspected DP, defined by the absence of thelarche by 13 years of age.\n* Written informed consent for study participation and personal data processing provided by the parents\u002Flegal guardians, with the assent of the participating minor.\n\nExclusion Criteria:\n\n* 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).\n* Primary endocrine diseases interfering with hypothalamic-pituitary-gonadal axis regulation (e.g., congenital hypogonadotropic hypogonadism, panhypopituitarism).\n* Use of hormonal therapies or drugs capable of modifying gonadal function or the response to the GnRH test (e.g., exogenous sex steroids, androgens\u002Fanabolic steroids).","ALL","0 Years","18 Years",{"count":72,"type":73},100,"ESTIMATED","OBSERVATIONAL","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:\n\n* Can the level of insulin-like peptide 3 (INSL3) predict if a child's puberty has truly started?\n* Can this marker help reduce the need for more complex and invasive tests?\n\nParticipants will:\n\n* Give one extra blood sample just before starting the standard gonadotropin-releasing hormone (GnRH) stimulation test (during the baseline blood draw).\n* Have this extra sample used to measure the INSL3 hormone.\n* Complete the rest of the GnRH test as prescribed by their doctor.\n\nResearchers 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.",[77,78],"Precocious Puberty, Central","Delayed Puberty","2026-09-30",{"date":81,"type":82},"2026-10-06","ACTUAL",{"date":84,"type":73},"2026-10-02",{"date":86,"type":73},"2029-01-01",{"name":5,"class":6},1]