Pharmacogenomic Testing to Personalize Supportive Oncology

NCT04500301 | Completed Results DMC

• 3 other identifiers: IRB00081754Pro00045081LCI-SUPP-NOS-PGX-001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Depression; Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Pharmacogenomic Testing

EXPERIMENTAL

A pharmacogenomic (PGx) panel will be performed to test for genetic variations in genes related to drug response.

Other: Preemptive Pharmacogenomic Testing

Interventions

Preemptive Pharmacogenomic Testing OTHER

The use of a pharmacogenomic (PGx) testing to help manage drugs prescribed to subjects for pain and depression.

Pharmacogenomic Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent and HIPAA authorization for release of personal health information.
• Completion of ESAS at initial palliative medicine clinic visit, presenting with moderate to high pain (≥ 4/10) and/or depression (≥ 3/10).
• New patients ≥ 18 years of age who have had an initial visit in the Department of Supportive Oncology's palliative medicine clinic with hematologic malignancy or any stage solid tumor malignancy according to the provider.
• Agree to at least one additional palliative medicine clinic visit per protocol.
• Able to provide a buccal sample for PGx testing.

You may not qualify if:

• Psychiatric illness, social situations, or active/recent (within 30 days) history of illicit substance (e.g. cocaine, heroin) abuse that would limit compliance with study requirements (e.g. clinic visits, medication compliance, etc.) as determined by the Investigator.
• Patients who have had prior multiple visits in palliative medicine clinic.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Neoplasms; Depression; Pain

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Danielle M Boselli
• Organization: Wake Forest

Danielle.Boselli@AtriumHealth.org

2017903385

Study Officials

• Jai Patel, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 5, 2020
• Study Start: December 2, 2020
• Primary Completion: December 13, 2023
• Study Completion: December 13, 2023
• Last Updated: January 30, 2025
• Results First Posted: January 30, 2025

Record last verified: 2025-01

Locations

US (1)