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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 27 May 2013
Main ID:  NCT01059240
Date of registration: 28/01/2010
Primary sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Public title: SMN Copy Number Distribution in Mali, West Africa
Scientific title: SMN Copy Number Distribution in Mali, West Africa
Date of first enrolment: January 2010
Target sample size: 1400
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT01059240
Study type:  Observational
Study design:  Time Perspective: Prospective  
Countries of recruitment
Mali
Contacts
Name:   Modibo Sangare, M.D.
Address: 
Telephone: (301) 435-9319
Email: sangarem@ninds.nih.gov
Affiliation: 
Name:   Kenneth H Fischbeck, M.D.
Address: 
Telephone:
Email:
Affiliation:  National Institute of Neurological Disorders and Stroke (NINDS)
Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

Medical students at the FMPOS of Malian ancestry and nationality who are 18 years of age
and above will be considered for this study.

EXCLUSION CRITERIA:

Subjects may not be eligible to participate if they have a condition that would make a
single 6 ml blood draw unsafe. Student assistants are ineligible for the study
participation.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Spinal Muscular Atrophy
Intervention(s)
Primary Outcome(s)
Primary outcome measure for phase 1 is DNA extraction yield of sufficient quantity and quality for SMN genotyping in at least 90% of samples
Secondary Outcome(s)
Secondary outcome measures for phase 2 are the frequency of SMA carriers (SMN1 deletion heterozygotes) and the SMN1 and SMN2 copy number distribution in Mali.
Secondary ID(s)
10-N-N033
999910033
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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