Clinical trial · Interventional
Implementing Preemptive Pharmacogenomic Testing for Colorectal Cancer Patients in a Community Oncology Clinic
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OneOme RightMed® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OneOme RightMed® Test
- description
- 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).
- interventionNames
- Device: OneOme RightMed®
Primary outcomes (1)
- measure
- PGx Test Interpretation
- timeFrame
- 10 days
- description
- Proportion of patients with pharmacogenomic testing completed and interpreted prior to starting chemotherapy.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available