Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Assessment of Endocrine and Metabolic Late Effects After Childhood Brain Tumor Treatment

10. august 2026 opdateret af: Institute of Oncology Ljubljana

Late Endocrine and Metabolic Consequences of Treatment of Primary Brain Tumors in Childhood

This prospective, single-group interventional study evaluates endocrine and metabolic late effects in survivors of primary brain tumors treated during childhood. According to the study protocol, participants were prospectively assigned to undergo the Study-Specific Endocrine and Metabolic Late-Effects Assessment. The assessment included anthropometric measurements, repeated blood pressure measurements, clinical endocrine evaluation, fasting laboratory testing, and protocol-defined bone and vascular assessments. The purpose of the study was to identify the frequency and severity of endocrine and metabolic late effects and to evaluate their associations with tumor characteristics, previous cancer treatment, age at diagnosis, and physical functioning.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Survivors of primary brain tumors treated during childhood may develop endocrine, metabolic, neurological, psychological, and cardiovascular late effects several years after completion of cancer treatment.

This prospective, single-group interventional study included individuals who had been treated for a primary brain tumor in Slovenia between 2008 and 2018 while aged 0 to 18 years and who had survived for at least 5 years after diagnosis.

Following enrollment and informed consent, all participants were prospectively assigned, according to the study protocol, to undergo the same Study-Specific Endocrine and Metabolic Late-Effects Assessment. Participation in the study determined the standardized manner and intensity with which the protocol-defined procedures were performed; participants would not otherwise necessarily have received the same assessment package during routine clinical follow-up.

The protocol-defined assessment included review of medical history and previous cancer treatment, measurement of body weight, height, waist and hip circumference, arm span and sitting height, repeated blood pressure measurements, clinical assessment of endocrine and pubertal status, and fasting laboratory testing of endocrine and metabolic markers.

The study-specific assessment also included vascular evaluation by measurement of carotid intima-media thickness.When the relevant results were not already available, dual-energy X-ray absorptiometry for the assessment of bone mineral density and body composition, and pulse wave velocity assessment, were performed or arranged according to the study protocol.

Medical record data on tumor type and location, age at diagnosis, treatment modalities, date of treatment completion, current therapy, and previously identified late effects were also collected. No investigational medicinal product was administered.

The primary objective was to identify the occurrence and severity of endocrine and metabolic late effects following treatment of childhood brain tumors. Additional analyses evaluated associations between the identified late effects and tumor location, tumor type, treatment modality, age at diagnosis, and physical functioning.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

12

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Slovenien
      • Ljubljana, Slovenien, 1000
        • Institute of Oncology Ljubljana

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

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Individuals treated for a primary brain tumor in Slovenia between 2008 and 2018 while aged 0 to 18 years.
  • Survival for at least 5 years after the diagnosis of a primary brain tumor.
  • Written informed consent provided by the participant or, when applicable, by a parent or legal guardian.

Exclusion Criteria:

  • Failure to meet the inclusion criteria.
  • Absence of written informed consent from the participant or, when applicable, from a parent or legal guardian.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Study-Specific Endocrine and Metabolic Late-Effects Assessment
Participants were prospectively assigned to undergo the protocol-defined endocrine and metabolic late-effects assessment. The assessment included anthropometric measurements, repeated blood pressure measurements, clinical endocrine evaluation, fasting laboratory testing, and protocol-defined bone and vascular assessments.
Andet: Study-Specific Endocrine and Metabolic Late-Effects Assessment
According to the study protocol, participants underwent a study-specific assessment to identify endocrine and metabolic late effects after treatment of a primary brain tumor during childhood. The assessment included anthropometric measurements, repeated blood pressure measurements, clinical assessment of endocrine and pubertal status, and fasting laboratory testing of endocrine and metabolic markers. Vascular assessment included measurement of carotid intima-media thickness. Bone mineral density, body composition, and pulse wave velocity assessments were performed or arranged according to the protocol when the relevant results were not already available.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number and Percentage of Participants With at Least One Endocrine or Metabolic Late Effect
Tidsramme: Baseline
Number and percentage of participants with at least one endocrine or metabolic late effect identified by the protocol-defined Study-Specific Endocrine and Metabolic Late-Effects Assessment. Late effects were identified using medical history, clinical endocrine evaluation, anthropometric measurements, repeated blood pressure measurements, and laboratory findings, including growth-related, thyroid, gonadal, adrenal, glucose, insulin, lipid, liver, and vitamin D parameters.
Baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number and Percentage of Participants With Endocrine or Metabolic Late Effects by Tumor and Treatment Characteristics
Tidsramme: Baseline
Number and percentage of participants with endocrine or metabolic late effects, summarized according to tumor type and location, age at diagnosis, and previous treatment characteristics, including surgery, chemotherapy, and radiotherapy.
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Institute of Oncology Ljubljana

Efterforskere

  • Ledende efterforsker: Lorna Zadravec Zaletel, MD, PhD, Institute of Oncology Ljubljana

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 (Faktiske)

3. juli 2023

Primær færdiggørelse (Faktiske)

31. december 2025

Studieafslutning (Faktiske)

31. december 2025

Datoer for studieregistrering

Først indsendt

15. juli 2026

Først indsendt, der opfyldte QC-kriterier

15. juli 2026

Først opslået (Faktiske)

21. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. august 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • OI-LATE-BT-2023-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner