Clinical trial · Interventional
Implementing Pharmacogenetic Testing in Gastrointestinal Cancers
- 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) is the study of how genes affect a person's response to drugs. PGx testing for certain genes can help predict the risk of side effects from chemotherapy agents. Testing is not regularly performed in clinical practice due to long wait times for results and challenges with integrating test results in the electronic health record. Investigators leading this study hope to find out if providing cancer care providers with the ability to order a PGx test and electronically receive results with dosing recommendations will increase the use of these tests to guide treatment decisions and improve patient outcomes. This is a non-randomized implementation study, which means that all participants in this study will undergo genotyping for a pharmacogenetic test. The investigators will primarily measure the feasibility of using this test to guide cancer care.
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 |
|---|---|---|---|
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pharmacogenetic test | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DPYD/UGT1A1 pharmacogenetic testing
- description
- All patients will be screened for twelve single nucleotide polymorphisms (SNPs) in DPYD: DPYD\*2A, \*5, \*6, \*8, \*9A, \*10, \*12, \*13, rs2297595, rs115232898, rs67376798, HapB3. All patients will be screened for two SNPs in UGT1A1: UGT1A1\*6, \*28.
- interventionNames
- Device: Pharmacogenetic test
Primary outcomes (3)
- measure
- Feasibility: Number and Percentage of Participants Who Had Their Pharmacogenetic Tests Returned Prior to Initial Dose
- timeFrame
- 14 days
- description
- The Number and percentage of participants who had their pharmacogenetic tests returned prior to the first determined dose of chemotherapy.
- measure
- Fidelity: Level of Agreement With Dose Recommendations
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Able and willing to provide informed consent 2. Male or female, aged 18 years or older at the time of study initiation 3. Pathologically confirmed gastrointestinal malignancy for which treatment with a fluoropyrimidine and/or irinotecan is indicated 4. Willing to undergo blood or saliva sampling for PGx testing and comply with all study-related procedures 5. Life expectancy of at least 6 months Exclusion Criteria: 1. Prior treatment with irinotecan 2. DPYD or UGT1A1 genotype already known 3. Severe renal or hepatic impairment (or unacceptable laboratory values), including: * Neutrophil count of \<1.5 x 109/L, platelet count of \<100 x 109/L * Hepatic function as defined by serum bilirubin \>1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) \>2.5 x ULN, or in case of liver metastases ALT and AST\>5 x ULN * Renal function as defined by serum creatinine \>1.5 x ULN, or creatinine clearance \<60 ml/min (by Cockcroft-Gault Equation) 4. Women who are pregnant or breast feeding, or subjects who refuse to use reliable contraceptive methods throughout the study 5. Treating physician does not want subject to participate
References
Publications (1)
- DERIVEDVarughese LA, Bhupathiraju M, Hoffecker G, Terek S, Harr M, Hakonarson H, Cambareri C, Marini J, Landgraf J, Chen J, Kanter G, Lau-Min KS, Massa RC, Damjanov N, Reddy NJ, Oyer RA, Teitelbaum UR, Tuteja S. Implementing Pharmacogenetic Testing in Gastrointestinal Cancers (IMPACT-GI): Study Protocol for a Pragmatic Implementation Trial for Establishing DPYD and UGT1A1 Screening to Guide Chemotherapy Dosing. Front Oncol. 2022 Jul 5;12:859846. doi: 10.3389/fonc.2022.859846. eCollection 2022. PMID 35865463