How Neurofibromatosis Type 1 (NF1) Affects Schoolwork and... | NCT01626846

Studies
How Neurofibromatosis Type 1 (NF1) Affects Schoolwork and Self-Esteem

NCT01626846

Sponsor

John Jay High School

Status

Unknown status

Last Update Posted

Jun 25, 2012Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Neurofibromatosis Type 1

Interventions

Not provided

Countries

United States

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

Jun 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Not provided

Completion Date

Sep 2012Estimated

First Submitted Date

Jun 21, 2012

First Submission Date that Met QC Criteria

Jun 22, 2012

First Posted Date

Jun 25, 2012Estimated

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

Jun 22, 2012

Last Update Posted Date

Jun 25, 2012Estimated

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

The study will seek to determine whether there is a corresponding deficit in school performance for teenagers with NF1. Secondly, the study seeks to explore the issue of self-esteem in teenagers with NF1.

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

Not provided

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

50Estimated

Label	Type	Description	Intervention Names
NF1 teenagers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evidence of effect on self-esteem evidenced by self-esteem scores		4 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of Neurofibromatosis Type 1

Exclusion Criteria:

Neurofibromatosis Type 2
Schwannomatosis

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Teenagers aged 14-17 years with NF1

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chris Ramsay	Contact	914-355-8010		christopher.ramsay@klschools.org

Overall Officials

Name	Affiliation	Role
Eileen Karlik, PhD	Westchester Community College	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
John Jay High School	Recruiting	Cross River	New York	10518	United States

Condition Browse Module

MeSH Terms

ID	Term
D009456	Neurofibromatosis 1
D017253	Neurofibromatoses

Ancestor Terms

ID	Term
D009455	Neurofibroma
D018317	Nerve Sheath Neoplasms
D009380	Neoplasms, Nerve Tissue
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided