NCT04067960

Brief Summary

This early phase I trial studies how well a genetic test called pharmacogenomics works in directing the optimal use of supportive care medications in patients with stage III-IV cancer. Pharmacogenomics is the study of how genes may affect the body's response to and interaction with some prescription medications. Genes, which are inherited from parents, carry information that determines things such as eye color and blood type. Genes can also influence how patients process and respond to medications. Depending on the genetic makeup, some medications may work faster or slower or produce more or fewer side effects. Pharmacogenomics testing may help doctors learn more about how patients break down and process specific medications based on their genes and improve the quality of life of cancer patients receiving clinical care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jun 2019

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2022

Completed
Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

3.3 years

First QC Date

August 22, 2019

Last Update Submit

August 12, 2024

Conditions

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Biliary Tract CarcinomaClinical Stage III Cutaneous Melanoma AJCC v8Clinical Stage IV Cutaneous Melanoma AJCC v8Malignant Brain NeoplasmMalignant Genitourinary System NeoplasmMalignant Solid NeoplasmPancreatobiliary CarcinomaPathologic Stage III Cutaneous Melanoma AJCC v8Pathologic Stage IIIA Cutaneous Melanoma AJCC v8Pathologic Stage IIIB Cutaneous Melanoma AJCC v8Pathologic Stage IIIC Cutaneous Melanoma AJCC v8Pathologic Stage IV Cutaneous Melanoma AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8Prognostic Stage IV Breast Cancer AJCC v8Stage III Colorectal Cancer AJCC v8Stage III Ovarian Cancer AJCC v8Stage III Pancreatic Cancer AJCC v8Stage III Prostate Cancer AJCC v8Stage IIIA Colorectal Cancer AJCC v8Stage IIIA Ovarian Cancer AJCC v8Stage IIIA Prostate Cancer AJCC v8Stage IIIB Colorectal Cancer AJCC v8Stage IIIB Ovarian Cancer AJCC v8Stage IIIB Prostate Cancer AJCC v8Stage IIIC Colorectal Cancer AJCC v8Stage IIIC Ovarian Cancer AJCC v8Stage IIIC Prostate Cancer AJCC v8Stage IV Colorectal Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Stage IV Pancreatic Cancer AJCC v8Stage IV Prostate Cancer AJCC v8Stage IVA Colorectal Cancer AJCC v8Stage IVA Ovarian Cancer AJCC v8Stage IVA Pancreatic CancerStage IVA Prostate Cancer AJCC v8Stage IVB Colorectal Cancer AJCC v8Stage IVB Ovarian Cancer AJCC v8Stage IVB Pancreatic CancerStage IVB Prostate Cancer AJCC v8Stage IVC Colorectal Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

  • Changes in symptoms, quality of life (QOL), and perceptions about pharmacogenomics (PGx) testing

    Patient survey responses will be compared across administration time points to look for changes in symptoms, QOL, and perceptions about PGx testing.

    Baseline up to 3 months post consent

Secondary Outcomes (1)

  • Provider opinions surrounding the clinical utility/relevancy of PGx testing in cancer patients

    Up to 3 months

Study Arms (1)

Screening (pharmacogenomics testing)

EXPERIMENTAL

Patients undergo one-time collection of saliva sample for pharmacogenomics testing. Patients also complete quality of life assessment at baseline and at 3 months after pharmacogenomics testing.

Procedure: Biospecimen CollectionOther: Genetic TestingOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Biospecimen CollectionPROCEDURE

Undergo collection of saliva

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Screening (pharmacogenomics testing)
Genetic TestingOTHER

Undergo pharmacogenomics testing

Also known as: genetic analysis, Genetic Examination, Genetic Test
Screening (pharmacogenomics testing)
Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment
Screening (pharmacogenomics testing)
Questionnaire AdministrationOTHER

Ancillary studies

Screening (pharmacogenomics testing)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient enrolled to Mayo Clinic IRB: 18-000326
  • Patients with stage 3 or 4 breast, colorectal, prostate/genitourinary (GU), pancreato-biliary, brain, melanoma, and ovarian cancer
  • Individuals have agreed to participate and signed the study informed consent form

You may not qualify if:

  • Patients with cancer types other than the ones mentioned above
  • Patient with psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent
  • Previous PGx testing with results available within Mayo Clinic electronic medical record (EMR)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Brain NeoplasmsUrogenital NeoplasmsColorectal NeoplasmsOvarian NeoplasmsPancreatic NeoplasmsProstatic Neoplasms

Interventions

Specimen HandlingGenetic Testing

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGenital DiseasesEndocrine System DiseasesGonadal DisordersPancreatic DiseasesGenital Neoplasms, MaleGenital Diseases, MaleProstatic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • Jewel Samadder, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2019

First Posted

August 28, 2019

Study Start

June 6, 2019

Primary Completion

October 6, 2022

Study Completion

October 6, 2022

Last Updated

August 14, 2024

Record last verified: 2024-08

Locations

US(1)