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Implementing Pharmacogenetic Testing in Gastrointestinal Cancers
NA trial testing Pharmacogenetic test in Gastrointestinal Cancer in 552 participants. Completed in 9 October 2024.
| Lead sponsor | Abramson Cancer Center at Penn Medicine |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 552 |
| Start date | 26 March 2021 |
| Primary completion | 19 December 2023 |
| Estimated completion | 9 October 2024 |
| Sites | 3 locations across United States |
Abramson Cancer Center at Penn Medicine — full company profile →
18 and older, any sex, with Gastrointestinal Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Number and percentage of participants who had their pharmacogenetic tests returned prior to the first determined dose of chemotherapy.
| Group | Value | 95% CI |
|---|---|---|
| Prospective Cohort | 130 |
| Group | Value | 95% CI |
|---|---|---|
| Prospective Cohort | 95 |
The number and percentage of participants with dose modifications made in agreement with the genotype-guided dosing recommendations for the first dose of chemotherapy.
| Group | Value | 95% CI |
|---|---|---|
| Prospective Cohort | 11 |
| Group | Value | 95% CI |
|---|---|---|
| Prospective Cohort | 6 |
| Group | Value | 95% CI |
|---|---|---|
| Prospective Cohort | 5 |
The number and percentage of participants with pharmacogenetic tests ordered compared to the number of patients eligible for testing at participating sites during the study timeframe
| Group | Value | 95% CI |
|---|---|---|
| Unique Patients Prescribed 5-FU | 288 |
Percentage of patients experiencing a severe TRAE (an event requiring hospitalization, emergency room visits, or oncology evaluation center). Severe TRAEs were one of the outcomes measured by the study.
| Group | Value | 95% CI |
|---|---|---|
| Prospective Cohort, DGI Group | 6 | |
| Prospective Cohort, Non-DGI Group | 63 | |
| BioBank Cohort, DGI Group | 10 | |
| BioBank Cohort, Normal Metabolizers Group | 66 | |
| Confirmatory Cohort | 10 |
| Group | Value | 95% CI |
|---|---|---|
| Prospective Cohort, DGI Group | 6 | |
| Prospective Cohort, Non-DGI Group | 107 | |
| BioBank Cohort, DGI Group | 13 | |
| BioBank Cohort, Normal Metabolizers Group | 108 | |
| Confirmatory Cohort | 12 |
| Group | Value | 95% CI |
|---|---|---|
| Prospective Cohort, DGI Group | 5 | |
| Prospective Cohort, Non-DGI Group | 49 | |
| BioBank Cohort, DGI Group | 8 | |
| BioBank Cohort, Normal Metabolizers Group | 60 | |
| Confirmatory Cohort | 8 |
Time frame: Adverse event data was collected during the first six cycles of chemotherapy, <6 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Prospective Cohort | Confirmatory Cohort | BioBank Cohort |
|---|---|---|---|---|
| Other | General disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — |
| Pain | General disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Fever | General disorders | — | — | — |
| Sepsis | Infections and infestations | — | — | — |
| Weakness | General disorders | — | — | — |
| Thrombosis | Blood and lymphatic system disorders | — | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — |
| Reaction | System | Prospective Cohort | Confirmatory Cohort | BioBank Cohort |
|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Mucositis | Gastrointestinal disorders | — | — | — |
| Peripheral Neuropathy | Nervous system disorders | — | — | — |
| Hand Foot Syndrome | Skin and subcutaneous tissue disorders | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Heart Palpitations | Cardiac disorders | — | — | — |
| Chest Pain | Cardiac disorders | — | — | — |
| Febrile Neutropenia | Blood and lymphatic system disorders | — | — | — |
Most-reported serious reactions: Other, Vomiting, Diarrhea, Pain, Nausea, Fever, Sepsis, Weakness.
Data from ClinicalTrials.gov NCT04736472 adverse events section.
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.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing