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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04781205
Other study ID # CMC-16-0071-CTIL
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 1, 2019
Est. completion date December 2029

Study information

Verified date February 2021
Source Carmel Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A cluster randomized controlled study of 40 primary care clinics in Northern Israel (20 intervention clinics, 20 usual care clinics) to evaluate the value of introducing a precision medicine/genomic approach/paradigm on the clinical and economical outcomes of the clinics. Intervention includes 3 elements: 1. DNA extraction and evaluation (up to the level of WGS); 2. Feces sample for microbiome study, 3. Wearable devices for continuous monitoring of body functions. Expected number of participants is 100,000 in each arm. Results will be calculated for a clinic as a unit and not for individuals (each clinic to be compared to "twin" selected clinic).


Description:

Study major aim: Assess whether employing a paradigm of genomic/precision medicine in primary care clinics can lead to an improvement in the medical or economic outcomes of the clinic as a unit. Specific and secondary aims 1. Study differences in morbidity, mortality, quality of life or the cost of medical service indicators between clinics operating under a genome driven paradigm compared to usual care clinics. 2. Examine whether the public has an interest in extensive genetic testing. 3. Examine whether the medical staff has an interest and ability to assimilate a genomic approach in the routine clinic work. 4. Identify links between genetic markers (mutations, variants) and different diseases (incidence or clinical behavior) or different drug responses (resistance, effectiveness, side-effects). 5. Examine whether the implementation of prolonged personal monitoring devices will lead to improved morbidity and mortality indices. 6. Examine whether measuring genomic variability in the microbiome has implications on health status or means of coping with different diseases and different health conditions.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200000
Est. completion date December 2029
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All clinic adult population - All diseases Exclusion Criteria: - Mentality unable to understand and sign consent

Study Design


Intervention

Genetic:
Mutation arrays, NGS panels, GWAS, WES, WGS,
DNA extracted from peripheral blood as well as genetic analysis of bacteria from feces
Device:
wearable monitors
test various technologies of sensors to measure continuously various body functions and provide information to person and to physician

Locations

Country Name City State
Israel Carmel Medical Center Haifa

Sponsors (1)

Lead Sponsor Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary chronic diseases in clinic whole clinic Incidence rate/100,000 of major chronic diseases (hypertension, Hyperlipidemia, DM, IHD, Cancer) 5 years
Primary Mortality in clinic whole clinic mortality rate/100,000 of major chronic diseases (DM, cancer, IHD) 5 ytears
Primary costs in clinic Total annual cost of clinic activity in NIS, including cost of diagnostic tests and hospitalization 5 years
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