The Neurofibromatosis-associated Tumor Biobank | NCT03359304

Studies
The Neurofibromatosis-associated Tumor Biobank

NCT03359304

Sponsor

Ren tingting

Status

Not yet recruiting

Last Update Posted

Dec 2, 2017Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Neurofibromatoses

Interventions

Not provided

Countries

Not provided

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

Nov 2017

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2018Estimated

Primary Completion Date

Mar 1, 2023Estimated

Completion Date

Mar 1, 2028Estimated

First Submitted Date

Nov 25, 2017

First Submission Date that Met QC Criteria

Nov 29, 2017

First Posted Date

Dec 2, 2017Actual

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

Nov 29, 2017

Last Update Posted Date

Dec 2, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

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

Neurofibromatosis-associated Tumor is very rare bone tumor. The investigator set up the biobank to ensure every patient has the chance to participate in future research

Detailed Description

Samples of blood and other stored material such as slides,frozen tissues or leftover diagnostic material.

Questionnaire information, including health history, growth and development, physical activity and family medical history information.

If patients have been diagnosed with a neurofibromatosis-associated tumor or another condition the investigator is interested in， the investigator will ask the patient to release medical record information relating to diagnosis and treatment of neurofibromatosis-associated tumor, other cancers, blood disorders, and similar conditions.

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

Retention

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detected NF-1 gene expression pattern in neurofibromatosis-asociated tumor	To examine the neurofibromatosis type 1(NF-1) gene expression of the patients with neurofibromatosis-associated tumor	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Proband Inclusion criteria: A diagnosis or suspected diagnosis of neurofibromatosis-associated tumor Family member inclusion criteria: Biological parents and full biological siblings of a case diagnosed with neurofibromatosis-associated tumor

Exclusion Criteria:

non-asian

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Asia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kuisheng Liu, phD	Contact	+8601088324471		tumorcenter@163.com

Overall Officials

Name	Affiliation	Role
Tingting Ren, phD	Peking University People's Hospital	Principal Investigator

Locations

Not provided

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
D017253	Neurofibromatoses
D001859	Bone Neoplasms

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