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Genome Driven Primary Care Clinics - an RCT

NCT04781205 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200000

Last updated 2021-03-04

No results posted yet for this study

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).

Conditions

  • Health Services Administration
  • Genetic Predisposition
  • Microbial Colonization

Interventions

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

Sponsors & Collaborators

  • Carmel Medical Center

    lead OTHER

Principal Investigators

  • Gad Rennert, MD, PhD · Clalit National Cancer Control Center Carmel Medical Center, Technion,

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2025-12-31
Completion
2029-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04781205 on ClinicalTrials.gov