Investigation of the Epidemiological Factors Associated W... | NCT03366506

Studies
Investigation of the Epidemiological Factors Associated With the Development of Amyotrophic Lateral Sclerosis (ALS)

NCT03366506

Sponsor

Hadassah Medical Organization

Status

Recruiting

Last Update Posted

Feb 10, 2021Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Interventions

Observation

Countries

Israel

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

Feb 2021

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 9, 2009Actual

Primary Completion Date

Mar 2049Estimated

Completion Date

Jan 2050Estimated

First Submitted Date

Dec 4, 2017

First Submission Date that Met QC Criteria

Dec 4, 2017

First Posted Date

Dec 8, 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

Feb 9, 2021

Last Update Posted Date

Feb 10, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

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

Investigation of the epidemiological factors associated with amyotrophic lateral sclerosis (ALS) in Israel with a view to future international collaboration. Particularly addressing:-

Differences between ethnic subgroups
Differences between immigrant and native-born populations
Differences according to military service profile Clinical features gathered at each routine visit ,throughout the entire course of the disease, will be recorded in database format, in order to correlate with potential epidemiological factors.

Detailed Description

Investigation of the epidemiological factors associated with amyotrophic lateral sclerosis (ALS) in Israel with a view to future international collaboration. Particularly addressing:-

Differences between ethnic subgroups
Differences between immigrant and native-born populations
Differences according to military service profile Clinical features gathered at each routine visit ,throughout the entire course of the disease, will be recorded in database format, in order to correlate with potential epidemiological factors.

The clinical features will include pattern of onset, details of full clinical exam ( including ALSFRS-R score, power, reflexes, and other signs of upper or lower-motor neuron dysfunction.

Correlations between different clinical parameters themselves will be made, as well as correlation between clinical parameters and other epidemiological factors.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ALS patients		ALS patients ( suspected, possible, probable or definite per El-Escorial criteria). Observation	Other: Observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other		ALS patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression rate	Progression of ALSFRS-R score over time	up to 10 years

Secondary Outcomes

Measure	Description	Time Frame
Appearance of clinical features of UMN or LMN dysfunction	Appearance of clinical features of UMN or LMN dysfunction over time	10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Suspected, possible, probable ,definite ALS

Exclusion Criteria:

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

120 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Population referred to ALS clinic with suspected, possible, probable ,definite ALS

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marc Gotkine, MBBS	Contact	+972507874692		marc@gotkine.com

Overall Officials

Name	Affiliation	Role
Marc Gotkine, MBBS	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organisation	Recruiting	Jerusalem		91120	Israel

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Via specific collaboration agreements.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided