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

NCT03187184 | Completed

• 1 other identifier: 021870
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• PGx Test Interpretation

  Proportion of patients with pharmacogenomic testing completed and interpreted prior to starting chemotherapy.

  10 days

Secondary Outcomes (2)

• Allele Frequency

  10 days

• Chemotherapy Toxicity

  3 months

Study Arms (1)

OneOme RightMed® Test

EXPERIMENTAL

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®

Interventions

OneOme RightMed® DEVICE

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).

OneOme RightMed® Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Adequate organ function and performance status to receive chemotherapy as determined by the treating physician.
• Age ≥ 18 years.
• Ability to understand and the willingness to sign a written informed consent documented.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Essentia Health: lead

Study Sites (1)

Essentia Health

Duluth, Minnesota, 55805, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Bret Friday, MD

  Essentia Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 14, 2017
• Study Start: May 20, 2017
• Primary Completion: December 20, 2018
• Study Completion: June 30, 2019
• Last Updated: October 22, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)