Clinical studies in genomics and individualized medicine help us understand how diseases develop and progress. We use this knowledge to develop better diagnostic tools and more effective therapies to improve patient care.
The Center for Individualized Medicine currently has four open clinical studies enrolling patients who meet certain eligibility criteria.
Breast cancer: STRIVE Study
The STRIVE Study is designed to evaluate a new test for the detection of breast cancer in its earlier stages, when the chance of a cure is greater. A blood test that looks at genetic material from an early developing tumor may help with mammographic work-ups and assist in finding cancers that are not easily found by standard breast cancer screening methods. The blood test may also help identify other types of cancers.
The goal of the STRIVE Study is to develop a blood test to be used with mammography to detect breast cancer early.
Pharmacogenomics: Right 10K Study
The RIGHT Protocol (short for the Right Drug, Right Dose, Right Time: Using Genomic Data to Individualize Treatment) studies the impact of getting patients the right drug at the right dose at the right time based on their genetic information.
Having developed and tested its systems with the initial 1,000 study participants, researchers are expanding the RIGHT Protocol to 10,000 Mayo Clinic Biobank participants (and now called the RIGHT 10K study). The study pre-emptively embeds a patient's genetic information in the electronic health record for future use to see if doing so improves long-term outcomes for both the patient and the health care delivery system at large.
Clinicians treating patients in the study can act on this information with the help of a pharmacogenomic "drug-gene pair" alert system developed Mayo Clinic.
Cancer Immunotherapy: Impress Study
The oncology departments across Mayo Clinic, together with research laboratories and the Biomarker Discovery Program of the Center for Individualized Medicine, have organized a three-site initiative to develop biomarkers to monitor response to PD-1/PD-L1 inhibitors to predict the benefit from immunotherapy.
Patients who will receive immunotherapy for a diagnosis of advanced melanoma, non-small cell lung cancer, renal cell cancer, bladder cancer, head and neck cancer, and other malignancies are recruited for participation from Mayo Clinic campuses in Minnesota, Arizona and Florida. By collecting participant biospecimens prior to and during immunotherapy, IMPRESS investigators hope to develop a method to predict and monitor patients' responses to immunotherapy treatment.
Breast Cancer: Promise Study
The Prospective Study to evaluate the role of Tumor Sequencing in Women Receiving Palbociclib for Advanced Hormone Receptor (HR)-Positive, Breast Cancer (PROMISE Study) is designed to obtain state of the art tumor sequencing information and to develop patient derived xenografts (PDX) in women with metastatic hormone receptor (HR)-positive breast cancer treated with palbociclib and endocrine therapy.
The goal of PROMISE, is to identify novel genomic alterations associated with early disease progression Eligible breast cancer patients who have been recommended to start palbociclib and endocrine therapy either in the first line (letrozole) or 2nd line (fulvestrant) setting will be recruited to participate in the PROMISE Study, and will undergo both tumor and blood sequencing. Patients will be provided the results of their baseline tumor sequencing after enrollment on PROMISE, and these data may be useful for the future treatment of their breast cancer.
Cardiovascular disease: TAILOR-PCI study
The Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention (TAILOR-PCI) study uses genetic information to find the best medication for patients who undergo coronary angioplasty, also known as percutaneous coronary intervention.
Up to 30 percent of patients receiving angioplasty have a genetic variant thought to interfere with their ability to metabolize standard antiplatelet medications. Alternative drugs exist, and this study investigates whether or not physicians should prescribe medication based on genotype.