NCT02851355

Brief Summary

Clinical follow-up survey of the Norwegian material of paediatric patients who received therapy for medulloblastoma and CNS-PNET from 1974 - 2013 with a focus on quality of life, education, work, family and children, delayed effects of tumour disease and treatment, endocrine evaluation, existence of auditory neuropathy, and neuropsychological testing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

June 22, 2016

Last Update Submit

March 13, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • SF 36 for those older than 18 years

    Questionnaire

    1 year

  • PedsQL for those younger than 18 years

    Questionnaire

    1 year

Eligibility Criteria

Age5 Years - 51 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Those children and adolescents who were younger than 18 years of age and who recived treatement for medulloblastoma or CNS-PNET in southern part of Norway between 1974 and 2013.

You may qualify if:

  • Whose who has been treated for medulloblastoma og CNS-PNET between 1974 and 2013

You may not qualify if:

  • Other brain tumours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Einar Stensvold

Oslo, 0450, Norway

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

June 22, 2016

First Posted

August 1, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2017

Study Completion

August 1, 2018

Last Updated

March 15, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations