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Amyotrophic Lateral Sclerosis: a New Paradigm (ALSParadigm)

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ClinicalTrials.gov Identifier: NCT03073239
Recruitment Status : Completed
First Posted : March 8, 2017
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Conde, Bebiana, M.D.

Tracking Information
First Submitted Date March 26, 2016
First Posted Date March 8, 2017
Last Update Posted Date July 23, 2018
Actual Study Start Date December 2016
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 2, 2017)
Finding environmental risk factor [ Time Frame: 2 years ]
Apply epidemiogycal form to All ALS patients sentido to respiratory evaluation in 2 years.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03073239 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 2, 2017)
  • Regional prevalence [ Time Frame: 1 year ]
    Identify All cases ALS in regional area ( in north of Portugal)
  • Finding a genetic marker [ Time Frame: 2 years ]
    Scan all ALS patients to eventually finding new ALS genes
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Amyotrophic Lateral Sclerosis: a New Paradigm
Official Title Amyotrophic Lateral Sclerosis: a New Paradigm
Brief Summary

Amyotrophic Lateral Sclerosis (ALS) is a degenerative neuromuscular disease, progressing inexorably to respiratory failure, the by involvement of respiratory muscles, the commitment with most impact on the prognosis of ALS.

According to current knowledge, the clinical presentation of the disease is characterized by spinal or bulbar involvement, the latter being associated with a worse prognosis.

There are multiple factors described in the aetiology of ALS, as the successive damage the motor neuron, which can happen in high-impact athletes, or exposure to heavy metals. Genetic mutations are also described, being associated to a higher prevalence of ALS.

Data from retrospective studies with ALS populations reveal a prevalence of 4-8 cases per 100,000 persons. Research carried out in Trás-os-Montes e Alto Douro region (Northeast of Portugal) shows a high prevalence of ALS, with near 10 cases per 100,000 persons, with a recent increase in the bulbar involvement. The reasons for the high prevalence of ALS in this region are unknown.

Detailed Description The objective of this research is to pursue potentially involved genetic mutations in this disease (new or previously described), in addition to carry out a epidemiological questionnaire including data on personal history, environmental and occupational exposure that might be underlying this high prevalence.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood to test als mutations
Sampling Method Non-Probability Sample
Study Population Patients with Amyotrophic Lateral Sclerosis sent to a medical consultation
Condition Amyotrophic Lateral Sclerosis
Intervention
  • Genetic: ALS patients genetic characterization
    Genetic findings in ALS patients
  • Other: ALS patients epidemiological caracterization
    Epidemiological characterization in ALS patients
Study Groups/Cohorts
  • ALS epidemiological characterization
    epidemiological characterization
    Intervention: Other: ALS patients epidemiological caracterization
  • Genetic findings in ALS patients
    genética characterization
    Intervention: Genetic: ALS patients genetic characterization
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 Completed
Actual Enrollment
 (submitted: July 19, 2018)
30
Original Estimated Enrollment
 (submitted: March 2, 2017)
40
Actual Study Completion Date June 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients with Amyotrophic Lateral Sclerosis sent to a medical consultation

Exclusion Criteria:

  • Amyotrophic Lateral Sclerosis not confirmed
  • Ages less than 18 years old
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Portugal
Removed Location Countries  
 
Administrative Information
NCT Number NCT03073239
Other Study ID Numbers 2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Research results will be shared with the scientific community through the publication of 2 to 3 papers in medical journals, as well as through the participation in national and international conferences. Whenever requested by the participants, the individual data resulting from clinical examinations will be provided.
Responsible Party Conde, Bebiana, M.D.
Study Sponsor Conde, Bebiana, M.D.
Collaborators Not Provided
Investigators
Principal Investigator: Bebiana Conde, MD Centro Hospitalar Tras-os-Montes e Alto Douro
PRS Account Conde, Bebiana, M.D.
Verification Date March 2017