Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 1105 for:    pharmacogenomics OR pharmacogenetics

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067960
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : August 29, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

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.

Condition or disease Intervention/treatment
Anatomic Stage III Breast Cancer AJCC v8 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 Clinical Stage III Cutaneous Melanoma AJCC v8 Clinical Stage IV Cutaneous Melanoma AJCC v8 Health Care Provider Malignant Brain Neoplasm Malignant Genitourinary System Neoplasm 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 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 Procedure: Biospecimen Collection Other: Genetic Testing Other: Quality-of-Life Assessment Other: Questionnaire Administration

Detailed Description:

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Precision Pharmacogenomics in Cancer Patients
Actual Study Start Date : June 6, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


Group/Cohort Intervention/treatment
Ancillary-correlative (pharmacogenomics testing)
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 Collection
Undergo collection of saliva

Other: Genetic Testing
Undergo pharmacogenomics testing
Other Names:
  • genetic analysis
  • Genetic Examination
  • Genetic Test

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  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 (analyzed qualitatively) across administration time points to look for changes in symptoms, QOL, and perceptions about PGx testing.


Secondary Outcome Measures :
  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 (analyzed qualitatively) 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.


Biospecimen Retention:   Samples With DNA
Saliva


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
200 patients that participated in Institutional Review Board (IRB) 18-000326 study with stage 3-4 cancer recruited through the Mayo Clinic Arizona cancer (oncology and surgery) clinics. 50 providers of the 200 patients will also participate in a brief survey.
Criteria

Inclusion Criteria:

  • Patient enrolled to Mayo Clinic IRB: 18-000326
  • Patients with stage 3 or 4 breast, colorectal, prostate/genitourinary (GU), pancreatic, 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067960


Locations
Layout table for location information
United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Niloy J. Samadder    480-342-6263      
Principal Investigator: Niloy J. Samadder         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Niloy J Samadder Mayo Clinic

Layout table for additonal information
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT04067960     History of Changes
Other Study ID Numbers: 19-002006
NCI-2019-04725 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
19-002006 ( Other Identifier: Mayo Clinic in Arizona )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Prostatic Neoplasms
Melanoma
Colorectal Neoplasms
Pancreatic Neoplasms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Skin Neoplasms
Brain Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases