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Trial record 27 of 103 for:    Pompe Disease

Screening for Early Detection and Prevention of Pompe Disease in Israel Using Tandem Mass Spectrometry (LC-MS-MS)

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ClinicalTrials.gov Identifier: NCT01409486
Recruitment Status : Unknown
Verified August 2011 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : August 4, 2011
Last Update Posted : August 4, 2011
Sponsor:
Information provided by:
Rambam Health Care Campus

Tracking Information
First Submitted Date July 7, 2011
First Posted Date August 4, 2011
Last Update Posted Date August 4, 2011
Study Start Date September 2011
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 3, 2011)
Identification of the normal mean control value of Alpha glucosidase activity in Dry blood spots among Newborns in Israel [ Time Frame: Two years ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Screening for Early Detection and Prevention of Pompe Disease in Israel Using Tandem Mass Spectrometry
Official Title Screening for Early Detection and Prevention of Pompe Disease in Israel Using Tandem Mass Spectrometry
Brief Summary

The aim of the study is:

to develop a comprehensive biochemical assay for detection of Pompe disease (glycogen storage disease type II), to be implemented in the Newborn screening program among the Israeli population.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 10000 full-term newborns born in Northern Israel
Condition Pompe Disease
Intervention Other: Drawing blood spots from Newborns
Dry blood spots would be taken for determination of Alpha Glucosidase activity using LC-MS-MS
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 3, 2011)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2013
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • New born babies born during the study period

Exclusion Criteria:

  • Premature babies
Sex/Gender
Sexes Eligible for Study: All
Ages up to 7 Days   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT01409486
Other Study ID Numbers 0290-09-RMB-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Prof. Hanna Mandel, Rambam Health Care Campus
Study Sponsor Rambam Health Care Campus
Collaborators Not Provided
Investigators Not Provided
PRS Account Rambam Health Care Campus
Verification Date August 2011