Clinical trials are designed to help provide the answers to some of medicine’s most difficult questions. It is through clinical trials, both initiated at NorthShore or done in collaboration with other leading-edge institutions, that we are able to better diagnose, treat and prevent diseases and other health conditions.
NorthShore currently offers a robust list of clinical trials across multiple disciplines—oncology, neurological care, orthopaedics, cardiovascular conditions and many more. Along with these trials, NorthShore is also participating in various clinical trials that have a specific focus on personalized medicine.
We expect that as the field of personalized medicine continues to develop and advance, our participation in additional trials will as well. We are currently recruiting patients in collaboration with other organizations for the below trials:
Tailored Antiplatelet Initiation to Lessen Outcomes due to Decreased Clopidogrel Response after Percutaneous Coronary Intervention (TAILOR-PCI)
Aims: This study is looking for participants who underwent a Percutaneous coronary intervention (PCI) procedure initially presenting with either acute coronary syndrome or stable coronary artery disease. The patients will be randomized to one of two groups (with 50:50 chance): the conventional therapy group in which the patients will receive clopidogrel (Plavix) once daily with retrospective genotype analysis performed at the end of one year of treatment; and the prospective genotyping group, in which the patients will have prospective genotyping performed (via a buccal swab) to guide anti-platelet therapy. Patients in this group who are identified to have reduced function CYP2C19 allele will receive ticagrelor (Brilinta) twice daily and patients with wild type CYP2C19 allele will receive clopidogrel (Plavix) once daily. The participants from both groups will have their genotype tested after one year from a stored blood sample drawn while at the hospital.
The purpose of this study is by using pharmacogenomics (perspective and retrospective genotyping) to determine whether choosing medication (antiplatelet therapy) based on an individual genotype will lead to better outcomes defined as a decrease in major cardiac events in patients undergoing PCI.
Participation in the study will last for 12 months with 3 follow up phone visits. The study is expected to be completed in 2016.
Diagnosis: Percutaneous coronary intervention (PCI) procedure
Principal Investigator/s: Jorge Saucedo, MD (NorthShore University HealthSytem); Naveen Pereira, MD (Mayo Clinic)
Sponsor: Mayo Clinic; Spartan Bioscience, Inc. is providing lab equipment for use in this study
Contact: Elena Genova, PhD, 847.444.5314; firstname.lastname@example.org and Jean Skelskey, RN, 847.570.1810; email@example.com
Open to Enrollment: Yes
Prostate Cancer Medically Optimized Genome-Enhanced Therapy (PROMOTE)*
Aims: This study will include patients with castrate resistant prostate cancer with metastasis who are initiating treatment with abiraterone acetate (AA). This study is currently open only at Mayo Clinic in Rochester, MN. Prior to beginning treatment with AA, patients will go to Mayo Clinic and will undergo a biopsy of a metastatic tumor and have blood drawn. Comprehensive genetic testing will be done on the tumor tissue and blood, including germline and tumor whole genome sequencing as well as implantation of tumor into nude mice. After 12 weeks of treatment with AA, a second biopsy of a metastatic tumor will be done at Mayo Clinic and a similar analysis will be done. Patients will be monitored closely at NorthShore for response to the treatment and changes in therapy will be done as deemed appropriate. Correlation between genetic features and response to AA treatment will be made and genetic data may be used to inform future treatments. Travel and lodging expenses will be covered and a 3 month supply of AA will be supplied by Mayo Clinic.
Diagnosis: Castrate resistant prostate cancer
Principal Investigator: Manish Kohli, MD
Sponsor: Mayo Clinic
Contact: Manish Kohli, MD, firstname.lastname@example.org; 507.284.3903
Open to enrollment: Yes
* This study is being done in collaboration with Mayo Clinic. Suitable patients will be referred to Mayo Clinic and jointly managed by NorthShore physician Daniel Shevrin, MD.