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

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ClinicalTrials.gov Identifier: NCT04158284
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Collaborators:
Gesellschaft für Pädiatrische Onkologie und Hämatologie (GPOH)
Deutsche Gesellschaft für Kinderendokrinologie und Diabetologie (DGKED)
Deutsche Gesellschaft für Endokrinologie (DGE)
Arbeitsgemeinschaft Pädiatrische Radioonkologie (APRO)
Deutschen Gesellschaft für Radioonkologie (DEGRO)
Information provided by (Responsible Party):
Prof. Dr. med. Hermann Mueller, Klinikum Oldenburg gGmbH

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
Craniopharyngioma Obesity

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
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 : October 1, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021





Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 3 years follow-up ]
    Overall survival as measured by Kaplan Meyer analyses

  2. Progression-free Survival (PFS) [ Time Frame: 3 years follow-up ]
    Progression-free survival as measured by Kaplan Meyer analyses


Secondary Outcome Measures :
  1. Quality of life (QoL) [ Time Frame: 3 years follow-up ]
    Domains of the PedQol instrument (questionnaire for assessment of health-related QoL in childhood cancer patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Newly diagnosed patients (≤ 18 years of age) with childhood-onset craniopharyngioma
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158284


Contacts
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Contact: Hermann L Mueller, MD +49 441 403 ext 2013 mueller.hermann@klinikum-oldenburg.de
Contact: Svenja Boekhoff +49 441 403 ext 2072 boekhoff.svenja@klinikum-oldenburg.de

Locations
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Germany
Klinikum Oldenburg Recruiting
Oldenburg, Niedersachsen, Germany, 26133
Contact: Hermann L Mueller, MD    +49 441 403 ext 2013    mueller.hermann@klinikum-oldenburg.de   
Contact: Svenja Boekhoff    +49 441 403 ext 2072    boekhoff.svenja@klinikum-oldenburg.de   
Sponsors and Collaborators
Klinikum Oldenburg gGmbH
Gesellschaft für Pädiatrische Onkologie und Hämatologie (GPOH)
Deutsche Gesellschaft für Kinderendokrinologie und Diabetologie (DGKED)
Deutsche Gesellschaft für Endokrinologie (DGE)
Arbeitsgemeinschaft Pädiatrische Radioonkologie (APRO)
Deutschen Gesellschaft für Radioonkologie (DEGRO)

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Responsible Party: Prof. Dr. med. Hermann Mueller, Professor MD, Klinikum Oldenburg gGmbH
ClinicalTrials.gov Identifier: NCT04158284     History of Changes
Other Study ID Numbers: KRANIOPHARYNGEOM Registry 2019
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Keywords provided by Prof. Dr. med. Hermann Mueller, Klinikum Oldenburg gGmbH:
Quality of life
Endocrinology
Oncology
Hypothalamus
Irradiation
Neurosurgery
Pediatric Brain tumors
Additional relevant MeSH terms:
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Adenoma
Meningioma
Craniopharyngioma
Adamantinoma
Pituitary Neoplasms
Arachnoid Cysts
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Neoplasms, Nerve Tissue
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Bone Neoplasms
Bone Diseases
Musculoskeletal Diseases
Endocrine Gland Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms