Follow-up Survey of Patients Who Were Treated for Medullo... | NCT02851355

Studies
Follow-up Survey of Patients Who Were Treated for Medulloblastoma or Primitive Neuroectodermal Tumors of the Central Nervous in Norway

NCT02851355

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Mar 15, 2019Actual

Enrollment

2Actual

Phase

Not provided

Conditions

Brain Tumor

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Sep 2017Actual

Completion Date

Aug 2018Actual

First Submitted Date

Jun 22, 2016

First Submission Date that Met QC Criteria

Jul 27, 2016

First Posted Date

Aug 1, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2019

Last Update Posted Date

Mar 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SF 36 for those older than 18 years	Questionnaire	1 year
PedsQL for those younger than 18 years	Questionnaire	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Other brain tumours

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

51 Years

Standard Ages

ChildAdult

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.

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Einar Stensvold		Oslo		0450	Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001932	Brain Neoplasms

Ancestor Terms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided