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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03187184
Recruitment Status : Completed
First Posted : June 14, 2017
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Essentia Health

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Device: OneOme RightMed® Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a single arm proof of concept trial. Sequential boundaries will be used to monitor late PGx test returns (failure to receive OneOme RightMed® pharmacogenomic test results before initiating chemotherapy). The concept will be considered a failure if excessive numbers of late PGx test returns are seen, that is, if the number of late PGx test returns is equal to or exceeds bn out of n patients (see table below). This Pocock-boundary is based upon the probability of early failure when the rate of late PGx test returns is equal to the acceptable rate [event probability θ]. In this trial crossing the boundary will not result in early stopping, because chemotherapy treatment is not dependent upon receipt of PGx test results prior to treatment initiation, but may be used to revise future protocol methodology.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Implementing Preemptive Pharmacogenomic Testing for Colorectal Cancer Patients in a Community Oncology Clinic
Actual Study Start Date : May 20, 2017
Actual Primary Completion Date : December 20, 2018
Actual Study Completion Date : June 30, 2019

Arm Intervention/treatment
Experimental: OneOme RightMed® Test
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).
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).




Primary Outcome Measures :
  1. PGx Test Interpretation [ Time Frame: 10 days ]
    Proportion of patients with pharmacogenomic testing completed and interpreted prior to starting chemotherapy.


Secondary Outcome Measures :
  1. Allele Frequency [ Time Frame: 10 days ]
    The proportion of Essentia Health patients with metabolic enzyme alleles that could impact chemotherapy dosing will be reported. Descriptive statistics, proportion and 95% confidence interval (95% CI), will be reported.

  2. Chemotherapy Toxicity [ Time Frame: 3 months ]
    Toxicity will be reported for all patients and the sub-groups of patients with and without the metabolic enzyme alleles that could impact chemotherapy. Descriptive statistics, proportion and 95% confidence interval (95% CI), will be reported. Depending upon the sample sizes involved, either the chi-square test or Fisher's exact test will be used to compare the sub-groups.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically proven Stage 2-4 colon or rectal adenocarcinoma with an anticipated need for chemotherapy, which may include neoadjuvant, adjuvant or palliative treatment, and may include oral or intravenous chemotherapy.
  2. Adequate organ function and performance status to receive chemotherapy as determined by the treating physician.
  3. Age ≥ 18 years.
  4. Ability to understand and the willingness to sign a written informed consent documented.
  5. Patients must sign consent within 7 days of the physician visit for newly diagnosed or recurrent colorectal cancer when a patient is initially felt to be a candidate for chemotherapy.

Exclusion Criteria:

  1. Patients received prior chemotherapy for colorectal cancer in the last 12 months.
  2. Patients received prior OneOme RightMed® pharmacogenomic testing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03187184


Locations
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United States, Minnesota
Essentia Health
Duluth, Minnesota, United States, 55805
Sponsors and Collaborators
Essentia Health
Investigators
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Principal Investigator: Bret Friday, MD Essentia Health
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Responsible Party: Essentia Health
ClinicalTrials.gov Identifier: NCT03187184    
Other Study ID Numbers: 021870
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases