MedDataX Logo

Trial Outcomes & Findings for Pharmacogenomic Testing to Personalize Supportive Oncology (NCT NCT04500301)

NCT ID: NCT04500301

Last Updated: 2025-01-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

From the date of enrollment/buccal swab sample until the date subject completed study procedures or discontinued study participation, assessed up to 8 months

Results posted on

2025-01-30

Participant Flow

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.

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
70
Overall Study
COMPLETED
70
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacogenomic Testing to Personalize Supportive Oncology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Pharmacogenomic Testing
n=70 Participants
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.
Age, Continuous
59 years
n=5 Participants
Sex: Female, Male
Female
38 Participants
n=5 Participants
Sex: Female, Male
Male
32 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
23 Participants
n=5 Participants
Race (NIH/OMB)
White
47 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
70 participants
n=5 Participants

PRIMARY outcome

Timeframe: From the date of enrollment/buccal swab sample until the date subject completed study procedures or discontinued study participation, assessed up to 8 months

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.

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.

Outcome measures

Outcome measures
Measure
Pharmacogenomic Testing
n=66 Participants
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.
Proportion of Participants Receiving at Least One Drug/Dose Selection or Modification Based on PGx Results
9 Participants

Adverse Events

Pharmacogenomic Testing

Serious events: 0 serious events
Other events: 0 other events
Deaths: 13 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Danielle M Boselli

Wake Forest

Phone: 2017903385

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place