CraniopharyngiomaNCT04158284
Multicenter Registry for Patients With Childhood.Onset Craniopharyngioma, Xanthogranuloma, Cysts of Rathke's Pouch, Meningioma, Pituitary Adenoma, Arachnoid Cysts
An observational study of Craniopharyngioma and Obesity, run by Klinikum Oldenburg gGmbH at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Craniopharyngioma, Obesity
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2019to 30 Jun 2024
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Newly diagnosed patients (≤ 18 years of age) with childhood-onset craniopharyngioma
Who may be able to join
- Diagnosed with craniopharyngioma for the first time
- Age at diagnosis 18 years or less of age
- Agreement from patient's parents or legal guardian as well as the patient
Who cannot join
- Age at diagnosis over 18 years of age
- Diagnosis different from craniopharyngioma
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum Oldenburg
Oldenburg, Lower Saxony, 26133
Hermann L Mueller, MD, +49 441 403 ext. 2013, mueller.hermann@klinikum-oldenburg.de
Svenja Boekhoff, +49 441 403 ext. 2072, boekhoff.svenja@klinikum-oldenburg.de
About this study
Official title: KRANIOPHARYNGEOM Registry 2019 Multicenter Registry for Patients With Childhood-onset Craniopharyngioma, Xanthogranuloma, Cysts of Rathke's Pouch, Meningioma, Pituitary Adenoma, Arachnoid Cysts
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.
- Conditions
- Craniopharyngioma, Obesity
- Keywords
- Quality of life, Endocrinology, Oncology, Hypothalamus, Irradiation, Neurosurgery, Pediatric Brain tumors
- Medical subject headings
- Craniopharyngioma, Obesity, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival as measured by Kaplan Meyer analyses
Measured: 3 years follow-up
Progression-free Survival (PFS)
Progression-free survival as measured by Kaplan Meyer analyses
Measured: 3 years follow-up
Secondary outcomes (1)
Quality of life (QoL)
Domains of the PedQol instrument (questionnaire for assessment of health-related QoL in childhood cancer patients.
Measured: 3 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start1 Oct 2019
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CraniopharyngiomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Klinikum Oldenburg gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- German Society for Pediatric Oncology and Hematology GPOH gGmbH, Deutsche Gesellschaft für Kinderendokrinologie und Diabetologie (DGKED), Deutsche Gesellschaft für Endokrinologie (DGE), Arbeitsgemeinschaft Pädiatrische Radioonkologie (APRO), Deutschen Gesellschaft für Radioonkologie (DEGRO)
- Responsible party
- Principal investigator, Prof. Dr. med. Hermann Mueller, Klinikum Oldenburg gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158284
- Sponsor's protocol ID
- KRANIOPHARYNGEOM Registry 2019
- Status last verified
- Mar 2024
- First submitted
- 10 Oct 2019
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sowithayasakul P, Beckhaus J, Ozyurt J, Bison B, Friedrich C, Muller HL. Prolactin serum concentrations in childhood-onset craniopharyngioma patients. J Endocrinol Invest. 2025 Sep;48(9):2041-2051. doi: 10.1007/s40618-025-02622-4. Epub 2025 Jun 7.
PubMed 40481916Mann-Markutzyk LV, Beckhaus J, Ozyurt J, Mehren A, Friedrich C, Muller HL. Daytime sleepiness and health-related quality of life in patients with childhood-onset craniopharyngioma. Sci Rep. 2025 Mar 19;15(1):9407. doi: 10.1038/s41598-025-94384-5.
PubMed 40108339Wagener K, Beckhaus J, Boekhoff S, Friedrich C, Muller HL. Sporadic and neurofibromatosis type 2-associated meningioma in children and adolescents. J Neurooncol. 2023 Jul;163(3):555-563. doi: 10.1007/s11060-023-04344-0. Epub 2023 Jul 4.
PubMed 37402092Beckhaus J, Friedrich C, Boekhoff S, Calaminus G, Bison B, Eveslage M, Timmermann B, Flitsch J, Muller HL. Outcome after pediatric craniopharyngioma: the role of age at diagnosis and hypothalamic damage. Eur J Endocrinol. 2023 Mar 2;188(3):lvad027. doi: 10.1093/ejendo/lvad027.
PubMed 36857103
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KRANIOPHARYNGEOM Registry 2019 Multicenter Registry for Patients With Childhood-onset Craniopharyngioma, Xanthogranuloma, Cysts of Rathke's Pouch, Meningioma, Pituitary Adenoma, Arachnoid Cysts
- ClinicalTrials.gov ID
- NCT04158284
- Acronym / sponsor ID
- KRANIOPHARYNGEOM Registry 2019
- Conditions
- Craniopharyngioma, Obesity
- Keywords
- Quality of life, Endocrinology, Oncology, Hypothalamus, Irradiation, Neurosurgery, Pediatric Brain tumors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Klinikum Oldenburg gGmbHUniversity, hospital or other
- Collaborators
- German Society for Pediatric Oncology and Hematology GPOH gGmbH, Deutsche Gesellschaft für Kinderendokrinologie und Diabetologie (DGKED), Deutsche Gesellschaft für Endokrinologie (DGE), Arbeitsgemeinschaft Pädiatrische Radioonkologie (APRO), Deutschen Gesellschaft für Radioonkologie (DEGRO)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 8 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Newly diagnosed patients (≤ 18 years of age) with childhood-onset craniopharyngioma
Key inclusion criteria (3 listed)
- Diagnosed with craniopharyngioma for the first time
- Age at diagnosis 18 years or less of age
- Agreement from patient's parents or legal guardian as well as the patient
Key exclusion criteria (2 listed)
- Age at diagnosis over 18 years of age
- Diagnosis different from craniopharyngioma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Quality of life (QoL)
Time frame: 3 years follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Derived from this study: PubMed 40481916Sowithayasakul P, Beckhaus J, Ozyurt J, Bison B, Friedrich C, Muller HL. Prolactin serum concentrations in childhood-onset craniopharyngioma patients. J Endocrinol Invest. 2025 Sep;48(9):2041-2051. doi: 10.1007/s40618-025-02622-4. Epub 2025 Jun 7.
- Derived from this study: PubMed 40108339Mann-Markutzyk LV, Beckhaus J, Ozyurt J, Mehren A, Friedrich C, Muller HL. Daytime sleepiness and health-related quality of life in patients with childhood-onset craniopharyngioma. Sci Rep. 2025 Mar 19;15(1):9407. doi: 10.1038/s41598-025-94384-5.
- Derived from this study: PubMed 37402092Wagener K, Beckhaus J, Boekhoff S, Friedrich C, Muller HL. Sporadic and neurofibromatosis type 2-associated meningioma in children and adolescents. J Neurooncol. 2023 Jul;163(3):555-563. doi: 10.1007/s11060-023-04344-0. Epub 2023 Jul 4.
- Derived from this study: PubMed 36857103Beckhaus J, Friedrich C, Boekhoff S, Calaminus G, Bison B, Eveslage M, Timmermann B, Flitsch J, Muller HL. Outcome after pediatric craniopharyngioma: the role of age at diagnosis and hypothalamic damage. Eur J Endocrinol. 2023 Mar 2;188(3):lvad027. doi: 10.1093/ejendo/lvad027.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Craniopharyngioma and Obesity, run by Klinikum Oldenburg gGmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hermann L Mueller, MD (+49 441 403 ext. 2013, mueller.hermann@klinikum-oldenburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 3 years follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04158284, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.