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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HG012273 | U.S. NIH Grant/Contract | View source |
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pending study amendment/re-design
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| Name | Class |
|---|---|
| National Human Genome Research Institute (NHGRI) | NIH |
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Doctors leading this study hope to find out if giving study participants' genetic information to cancer care providers will help personalize chemotherapy dosing decisions and decrease common chemotherapy side effects. Doctors leading the study will collect genetic information from study participants using pharmacogenomics/genotyping. Pharmacogenomics is the study of how the differences in our genes can affect our unique response to medications.
This is a randomized study, which means that participants in this study will be randomly assigned (as if "by flip of a coin") to one of two different groups: a "pharmacogenomics group" or "control group".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Participants assigned to the control group will receive standard chemotherapy without their doctors receiving any genetic information based on the participants' pharmacogenetic results. DNA (Deoxyribonucleic acid) samples for participants in this group will be stored and tested for genotyping six months later after treatment (or earlier if the participant experiences side effects). | |
| Pharmacogenomics Group | Experimental | Participants enrolled in the pharmacogenomics group will give a DNA (deoxyribonucleic acid) sample for immediate pharmacogenomic genotyping. Once the genotyping results are in, cancer doctors caring for each participant will have immediate access to clinical decision support based on the participant's genetic results and can make dosing decisions/changes to the participant's chemotherapy prescription. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Availability of clinical decision support based on pharmacogenomic results. | Other | Availability of clinical decision support based on pharmacogenomic results. These results are designed to provide specific dosing information based on the participant's unique genetics/genomics. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Deviation Rate (Co-Primary Endpoint) | To assess the impact of prospective pharmacogenomic testing on dose intensity deviation rate of chemotherapy during the 1st treatment cycle, comparing control vs. pharmacogenomics-guided arms. | 15 months |
| Grade 3 or Higher Toxicity (Co-Primary Endpoint) | To determine the degree to which providing oncologists with comprehensive pharmacogenomic information impacts the incidence of Grade 3 or worse toxicities in subjects receiving chemotherapy. Toxicities will be assessed by Common Terminology Criteria for Adverse Events version 5. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Chemotherapy Dose Intensity | Cumulative drug dose intensity received (function of dose and frequency of drug administration). | 5 years. |
| Response Rate | Anti-cancer tumor response based on radiographic assessment (complete response, partial response, stable disease, progressive disease), by tumor type and disease setting. |
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Inclusion Criteria Adult patients receiving oncology care at The University of Chicago Medical Center, and for whom treatment with a fluoropyrimidine and/or irinotecan is planned are eligible.
Individuals of all genders, races and ethnic groups are eligible for this trial. There is no bias towards race, sex, or gender in the clinical trial outlined.
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Peter H. O'Donnell, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
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Blinded
| 5 years. |
| Progression free survival (PFS) | Progression free survival (PFS) by tumor type and disease setting. | 5 years |
| Overall Survival | Overall survival (OS) by tumor type and disease setting. | 5 years |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D054067 | Dihydropyrimidine Dehydrogenase Deficiency |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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