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Completed

NCT Number: NCT04067960

Pharmacogenomics Testing in the Optimal Use of Supportive Care Medications in Stage III-IV Cancer

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.

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Key information

Conditions

Anatomic Stage III Breast Cancer AJCC v8 Adnexal Diseases Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Anatomic Stage IV Breast Cancer AJCC v8 Biliary Tract Carcinoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Clinical Stage III Cutaneous Melanoma AJCC v8 Clinical Stage IV Cutaneous Melanoma AJCC v8 Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Male Urogenital Diseases Malignant Brain Neoplasm Malignant Genitourinary System Neoplasm Malignant Solid Neoplasm Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Neoplasms Pancreatobiliary Carcinoma Pathologic Stage III Cutaneous Melanoma AJCC v8 Pathologic Stage IIIA Cutaneous Melanoma AJCC v8 Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 Pathologic Stage IV Cutaneous Melanoma AJCC v8 Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8 Prognostic Stage IV Breast Cancer AJCC v8 Prostatic Diseases Prostatic Neoplasms Rectal Diseases Stage III Colorectal Cancer AJCC v8 Stage III Ovarian Cancer AJCC v8 Stage III Pancreatic Cancer AJCC v8 Stage III Prostate Cancer AJCC v8 Stage IIIA Colorectal Cancer AJCC v8 Stage IIIA Ovarian Cancer AJCC v8 Stage IIIA Prostate Cancer AJCC v8 Stage IIIB Colorectal Cancer AJCC v8 Stage IIIB Ovarian Cancer AJCC v8 Stage IIIB Prostate Cancer AJCC v8 Stage IIIC Colorectal Cancer AJCC v8 Stage IIIC Ovarian Cancer AJCC v8 Stage IIIC Prostate Cancer AJCC v8 Stage IV Colorectal Cancer AJCC v8 Stage IV Ovarian Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8 Stage IV Prostate Cancer AJCC v8 Stage IVA Colorectal Cancer AJCC v8 Stage IVA Ovarian Cancer AJCC v8 Stage IVA Pancreatic Cancer Stage IVA Prostate Cancer AJCC v8 Stage IVB Colorectal Cancer AJCC v8 Stage IVB Ovarian Cancer AJCC v8 Stage IVB Pancreatic Cancer Stage IVB Prostate Cancer AJCC v8 Stage IVC Colorectal Cancer AJCC v8 Urogenital Diseases Urogenital Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

About this study

PRIMARY OBJECTIVES:

I. Evaluate patient perceptions surrounding their quality of life (QOL) prior to pharmacogenomics (PGx) testing and 3 months post PGx testing.

II. Understand the clinical utility/relevancy of PGx testing in cancer patients at Mayo Clinic Arizona from the viewpoint of their providers.

OUTLINE:

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.

After completion of study, patients are followed for up to 1 year.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of saliva

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Genetic Testing

Other

Undergo pharmacogenomics testing

Other names: genetic analysis, Genetic Examination, Genetic Test

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

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

    Time frame: Baseline up to 3 months post consent

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

Secondary outcomes

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

    Time frame: Up to 3 months

    Will qualitatively assess provider opinions surrounding the clinical utility/relevancy of PGx testing in cancer patients via the provider survey. Provider survey responses will be examined to determine the range of perceptions and experiences associated with PGx testing and result reporting for patient tests. Descriptive statistics will be used to report provider survey results.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Precision Pharmacogenomics in Cancer Patients

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2019
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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