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

• Sponsor: Klinikum Oldenburg gGmbH (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04158284
• Collaborator: Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany (Other), Deutsche Gesellschaft für Kinderendokrinologie und Diabetologie (DGKED) (Other), Deutsche Gesellschaft für Endokrinologie (DGE) (Other), Arbeitsgemeinschaft Pädiatrische Radioonkologie (APRO) (Other), Deutschen Gesellschaft für Radioonkologie (DEGRO) (Other)
• Enrollment: 90
• Location: 1
• Anticipated Duration (Months): 57
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Craniopharyngioma; Obesity

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 90 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: KRANIOPHARYNGEOM Registry 2019 Multicenter Registry for Patients With Childhood-onset Craniopharyngioma, Xanthogranuloma, Cysts of Rathke's Pouch, Meningioma, Pituitary Adenoma, Arachnoid Cysts
• Actual Study Start Date: Oct 1, 2019
• Anticipated Primary Completion Date: Jun 30, 2024
• Anticipated Study Completion Date: Jun 30, 2024

Outcome Measures

Primary Outcome Measures

1. Overall Survival [3 years follow-up]

   Overall survival as measured by Kaplan Meyer analyses

2. Progression-free Survival (PFS) [3 years follow-up]

   Progression-free survival as measured by Kaplan Meyer analyses

Secondary Outcome Measures

1. Quality of life (QoL) [3 years follow-up]

   Domains of the PedQol instrument (questionnaire for assessment of health-related QoL in childhood cancer patients.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinikum Oldenburg	Oldenburg	Niedersachsen	Germany	26133

Sponsors and Collaborators

• Klinikum Oldenburg gGmbH
• Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
• Deutsche Gesellschaft für Kinderendokrinologie und Diabetologie (DGKED)
• Deutsche Gesellschaft für Endokrinologie (DGE)
• Arbeitsgemeinschaft Pädiatrische Radioonkologie (APRO)
• Deutschen Gesellschaft für Radioonkologie (DEGRO)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Dr. med. Hermann Mueller, Professor MD, Klinikum Oldenburg gGmbH
• ClinicalTrials.gov Identifier: NCT04158284
• Other Study ID Numbers: KRANIOPHARYNGEOM Registry 2019
• First Posted: Nov 8, 2019
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Keywords provided by Prof. Dr. med. Hermann Mueller, Professor MD, Klinikum Oldenburg gGmbH: Quality of life; Endocrinology; Oncology; Hypothalamus; Irradiation; Neurosurgery; Pediatric Brain tumors
• Additional relevant MeSH terms: Adenoma; Meningioma; Pituitary Neoplasms; Craniopharyngioma; Adamantinoma; Arachnoid Cysts

Study Results

No Results Posted as of Mar 31, 2022