The Role of Igf-1 Generation Test in Diagnosis and Treatm... | NCT01970800

Studies
The Role of Igf-1 Generation Test in Diagnosis and Treatment of Short Stature

NCT01970800

Sponsor

Maimonides Medical Center

Status

Withdrawn

Last Update Posted

Aug 17, 2018Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Short Stature

Interventions

Growth Hormone

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

Aug 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Nature of study was changed from ACT to retrospective chart review

Expanded Access Info

Start Date

Jan 2013Actual

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Oct 23, 2013

First Submission Date that Met QC Criteria

Oct 25, 2013

First Posted Date

Oct 28, 2013Estimated

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

Aug 15, 2018

Last Update Posted Date

Aug 17, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 purpose of the study is to evaluate the predictive value of IGF-1 generation test for growth velocity during GH treatment for 12 months.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Growth hormone, injections	Experimental	Growth hormone injection 0.3mg/kg/week dailY	Drug: Growth Hormone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Growth Hormone	Drug	Will obtain daily injections and will evaluate the IGF-1 and IGFBP3 every 3 months	Growth hormone, injections

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary Efficacy Outcome measurement	Growth velocity after treatment with appropriate growth hormone doses	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ability to provide written informed consent
Prepubertal males and females form 5- 11years old
Bone age <11 years in males and <9 years in females
Height SD score<-2.25SD in males and females
IGF-1SD score <-1SD in both males and females
Peak GH level after stimulation >10ng/ml

Exclusion Criteria:

History of prior chemotherapy and or radiation
Active neoplasm
Pediatric patients with closed epiphyses
Prader-Willi syndrome, Turner syndrome or any other genetic or chromosomal anomaly
Treatment with inhaled or systemic steroids
BMI <5th percentile or >95th percentile
Tanner 2 at clinical or biochemical examination by ultrasensitive LH and FSH

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Svetlana Ten, MD	Maimonides Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maimonides Medical Center		Brooklyn	New York	11219	United States

Condition Browse Module

MeSH Terms

ID	Term
D004392	Dwarfism

Ancestor Terms

ID	Term
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D030342	Genetic Diseases, Inborn

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013006	Growth Hormone

Ancestor Terms

ID	Term
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided