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NCT04158284 Clinical Trial

Multicenter Registry for Patients With Childhood.Onset Craniopharyngioma, Xanthogranuloma, Cysts of Rathke's Pouch, Meningioma, Pituitary Adenoma, Arachnoid Cysts

Obesity Clinical Trial

Official title:
KRANIOPHARYNGEOM Registry 2019 Multicenter Registry for Patients With Childhood-onset Craniopharyngioma, Xanthogranuloma, Cysts of Rathke's Pouch, Meningioma, Pituitary Adenoma, Arachnoid Cysts

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04158284
Other study ID # KRANIOPHARYNGEOM Registry 2019
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date June 30, 2024

Study information
Verified date March 2024
Source Klinikum Oldenburg gGmbH
Contact Hermann L Mueller, MD
Phone +49 441 403
Email mueller.hermann@klinikum-oldenburg.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

KRANIOPHARYNGEOM Registry 2019 will prospectively collect and descriptively analyse data on diagnostics, treatment, and follow-up of patients with craniopharyngioma. In continuation of preceding studies also patients with xanthogranuloma, meningioma, pituitary adenoma, prolactinoma and cystic intracranial malformations will be registered.

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 1 Day to 18 Years
Eligibility Inclusion Criteria: 1. Diagnosed with craniopharyngioma for the first time 2. Age at diagnosis 18 years or less of age 3. Agreement from patient's parents or legal guardian as well as the patient Exclusion Criteria: 1. Age at diagnosis over 18 years of age 2. Diagnosis different from craniopharyngioma

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Klinikum Oldenburg Oldenburg Niedersachsen

Sponsors (6)
Lead Sponsor Collaborator
Klinikum Oldenburg gGmbH Arbeitsgemeinschaft Pädiatrische Radioonkologie (APRO), Deutsche Gesellschaft für Endokrinologie (DGE), Deutsche Gesellschaft für Kinderendokrinologie und Diabetologie (DGKED), Deutschen Gesellschaft für Radioonkologie (DEGRO), German Society for Pediatric Oncology and Hematology GPOH gGmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall Survival Overall survival as measured by Kaplan Meyer analyses 3 years follow-up
Primary Progression-free Survival (PFS) Progression-free survival as measured by Kaplan Meyer analyses 3 years follow-up
Secondary Quality of life (QoL) Domains of the PedQol instrument (questionnaire for assessment of health-related QoL in childhood cancer patients. 3 years follow-up
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