Implementing Pharmacogenetic Testing in Gastrointestinal Cancers

Gastrointestinal Cancer Clinical Trial

— IMPACT-GI  

Official title:

Implementing Pharmacogenetic Testing in Gastrointestinal Cancers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04736472
• Other study ID #: UPCC 22220
• Secondary ID: 844763
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 26, 2021
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 316
• Est. completion date: June 2024
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Device:
• Pharmacogenetic test
Patients with reduced function alleles (DPYD intermediate or poor metabolizer and/or UGT1A1 poor metabolizer) will be recommended to receive dose reductions per clinical pharmacogenetic guidelines. Patients that do not carry actionable alleles (DPYD normal metabolizer and/or UGT1A1 normal or intermediate metabolizer) will receive standard dosing.

Locations

Country	Name	City	State
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: proportion of pharmacogenetic tests returned prior to initial dose	The proportion of pharmacogenetic tests returned prior to the first determined dose of chemotherapy.	14 days
Primary	Fidelity: level of agreement with dose recommendations	The proportion of dose modifications made in agreement with the genotype-guided dosing recommendations for the first dose of chemotherapy.	14 days
Primary	Penetrance: proportion of pharmacogenetic tests ordered by providers	The proportion of pharmacogenetic tests ordered compared to the number of patient with eligible for testing	14 days
Secondary	Grade 3 or higher toxicity	Proportion of patients experiencing grade 3 or higher chemotherapy induced toxicity	6 months