Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date October 10, 2019
First Posted Date November 8, 2019
Last Update Posted Date November 8, 2019
Actual Study Start Date October 1, 2019
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 6, 2019)
  • Overall Survival [ Time Frame: 3 years follow-up ]
    Overall survival as measured by Kaplan Meyer analyses
  • Progression-free Survival (PFS) [ Time Frame: 3 years follow-up ]
    Progression-free survival as measured by Kaplan Meyer analyses
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 6, 2019)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multicenter Registry for Patients With Childhood.Onset Craniopharyngioma, Xanthogranuloma, Cysts of Rathke's Pouch, Meningioma, Pituitary Adenoma, Arachnoid Cysts
Official Title KRANIOPHARYNGEOM Registry 2019 Multicenter Registry for Patients With Childhood-onset Craniopharyngioma, Xanthogranuloma, Cysts of Rathke's Pouch, Meningioma, Pituitary Adenoma, Arachnoid Cysts
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Newly diagnosed patients (≤ 18 years of age) with childhood-onset craniopharyngioma
Condition
  • Craniopharyngioma
  • Obesity
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 6, 2019)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04158284
Other Study ID Numbers KRANIOPHARYNGEOM Registry 2019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Prof. Dr. med. Hermann Mueller, Klinikum Oldenburg gGmbH
Study Sponsor Klinikum Oldenburg gGmbH
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)
Investigators Not Provided
PRS Account Klinikum Oldenburg gGmbH
Verification Date November 2019