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Implementing Preemptive Pharmacogenomic Testing for Colorectal Cancer Patients in a Community Oncology Clinic

NCT03187184 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-10-22

No results posted yet for this study

Summary

Pharmacogenomics (PGx) studies the interactions between an individuals genes and medications. PGx testing identifies genes within an individual that may affect treatment, efficacy, and toxicity of drugs. With improvements in testing speed, accuracy and cost, it is now possible to perform PGx testing in cancer patients prior to starting chemotherapy. The test results may help a physician personalize chemotherapy dosing. The goal of this study is to determine if PGx testing using the OneOme® Rightmed test is feasible in a community oncology clinic to guide treatment prior to starting chemotherapy. The study will also gather data regarding the frequency of genes within the local population as well as the impact of testing on chemotherapy doses.

Conditions

Interventions

DEVICE

OneOme RightMed®

OneOme RightMed® currently tests for 22 genes that impact over 340 drugs used in multiple fields of medicine, including oncology. The drugs tested for by OneOme RightMed® were generated from practice guidelines and the FDA's guidelines for genotyping, and drugs with published, clinical evidence supporting genotyping. Testing is done using a prepackaged OneOme RightMed® kit to collect a buccal swab. OneOme RightMed® PGx test uses a DNA Genotek ORAcollect OC-100 buccal swab kit to extract DNA, which is then analyzed through polymerase chain reaction (PCR).

Sponsors & Collaborators

  • Essentia Health

    lead OTHER

Principal Investigators

  • Bret Friday, MD · Essentia Health

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-20
Primary Completion
2018-12-20
Completion
2019-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03187184 on ClinicalTrials.gov