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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00045081 | |||
| LCI-SUPP-NOS-PGX-001 | Other Identifier | Atrium Health |
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The purpose of this study is to evaluate pharmacogenomics (PGx) guided drug prescribing for pain and depression in patients with cancer. The investigators aim to understand how PGx testing can be used to improve medication management for pain and depression, and whether PGx-guided prescribing improves these symptoms and quality of life compared to historical controls.
This is a prospective clinical trial of adult cancer patients presenting with pain and depression, newly referred to the Department of Supportive Oncology, and receiving preemptive PGx testing for genes related to supportive care prior to the first clinic visit. Genotyping results will be returned within approximately 4-5 business days. A PGx specialist will provide detailed clinical interpretations to the referring provider and upload a copy of the test results into the subject's medical chart. A consultation note will also be placed in each subject's chart detailing the PGx results. Supportive Oncology clinicians will be instructed to consult a pharmacist to evaluate PGx test results prior to prescribing supportive care therapies, especially pain and depression medications. The number of consults and recommendations will be documented, in addition to test results, demographic data, medical/medication history, ESAS symptom scores, PHQ9 depression scores, and side effects of supportive therapy. The number of ambulatory clinic visits and hospitalizations will be used to estimate health care utilization and costs. Subjects will complete a short survey at the end of the study period regarding their knowledge about PGx, and whether access to PGx information improves satisfaction with care and communication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacogenomic Testing | Experimental | A pharmacogenomic (PGx) panel will be performed to test for genetic variations in genes related to drug response. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preemptive Pharmacogenomic Testing | Other | The use of a pharmacogenomic (PGx) testing to help manage drugs prescribed to subjects for pain and depression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Receiving at Least One Drug/Dose Selection or Modification Based on PGx Results | Estimate the proportion of subjects undergoing PGx testing who receive at least one drug/dose selection or modification based on PGx test results at any study visit where PGx results are available. A binary variable was determined for each subject indicating whether or not they received at least one drug/dose selection or modification based on PGx results where PGx results were available. The proportion of participants receiving at least one drug/dose selection or modification based on PGx results at any study visit where PGx results were available was calculated among all subjects in the analysis population. | From the date of enrollment/buccal swab sample until the date subject completed study procedures or discontinued study participation, assessed up to 8 months |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jai Patel, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
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Enrollment occurred at submission of the buccal swab sample. Seventy participants were enrolled/submitted buccal swab samples at the single-site medical clinic Levine Cancer Institute- Carolinas Medical Center between Dec 2, 2020 and July 18, 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pharmacogenomic Testing | A pharmacogenomic (PGx) panel will be performed to test for genetic variations in genes related to drug response. Preemptive Pharmacogenomic Testing: The use of a pharmacogenomic (PGx) testing to help manage drugs prescribed to subjects for pain and depression. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Pharmacogenomic Testing | A pharmacogenomic (PGx) panel will be performed to test for genetic variations in genes related to drug response. Preemptive Pharmacogenomic Testing: The use of a pharmacogenomic (PGx) testing to help manage drugs prescribed to subjects for pain and depression. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants Receiving at Least One Drug/Dose Selection or Modification Based on PGx Results | Estimate the proportion of subjects undergoing PGx testing who receive at least one drug/dose selection or modification based on PGx test results at any study visit where PGx results are available. A binary variable was determined for each subject indicating whether or not they received at least one drug/dose selection or modification based on PGx results where PGx results were available. The proportion of participants receiving at least one drug/dose selection or modification based on PGx results at any study visit where PGx results were available was calculated among all subjects in the analysis population. | Enrolled participants (i.e., submitted buccal swab sample) who (a) have confirmed malignancies (per provider documentation) and completed at least one study visit where PGx results were available. | Posted | Count of Participants | Participants | From the date of enrollment/buccal swab sample until the date subject completed study procedures or discontinued study participation, assessed up to 8 months |
|
From the date of enrollment/buccal swab sample until the date subject completed study procedures or discontinued study participation, assessed up to 8 months
The number of participants who died while on study is summarized. Other adverse events were not collected for study purposes as the intervention was unlikely to present harm to enrolled participants above standard of care.
The number of participants at risk for Serious Adverse Events is zero because adverse events were not monitored/assessed.
The number of participants at risk for Other (Not Including Serious) Adverse Events is zero because adverse events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pharmacogenomic Testing | A pharmacogenomic (PGx) panel will be performed to test for genetic variations in genes related to drug response. Preemptive Pharmacogenomic Testing: The use of a pharmacogenomic (PGx) testing to help manage drugs prescribed to subjects for pain and depression. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Danielle M Boselli | Wake Forest | 2017903385 | Danielle.Boselli@AtriumHealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2024 | Jan 8, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 16, 2022 | Aug 24, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D003863 | Depression |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Description |
|---|
| OG000 | Pharmacogenomic Testing | A pharmacogenomic (PGx) panel will be performed to test for genetic variations in genes related to drug response. Preemptive Pharmacogenomic Testing: The use of a pharmacogenomic (PGx) testing to help manage drugs prescribed to subjects for pain and depression. |
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|
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| 13 |
| 70 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |