Bench to Bedside: From the Laboratory to the Pharmacy
OSU-13053: Precision Cancer Medicine for Advanced Cancer Through High-Throughput Sequencing
Hypothesis: Genomics-based, personalized medicine in cancer is rapidly moving into the clinic due to advances in cost-efficient, high-throughput sequencing technology. We hypothesize that the ability to sequence individual cancers in real time will facilitate the design and implementation of clinical trials based on personalized cancer genomics; e.g., a clinical trial for a fibroblast growth factor receptor (FGFR) inhibitor that includes FGFR gene mutations as a molecular eligibility requirement. Clinically significant results will be disclosed to patients and their clinicians.
Rationale: This protocol evaluates a mechanism for the timely sequencing of tumor samples and the return of potentially clinically useful sequence results in patients with advanced or refractory cancer. This mechanism involves:
- Biospecimen collection – Patients will undergo a research tumor biopsy (most common) or contribute a tissue sample from a standard-of-care procedure or surgery (less common). Or, a previously collected tumor block can be contributed to the study. Research biopsies are done to evaluate a patient’s current disease that has become resistant to previous therapies. Patients will also provide blood, buccal smear and serum samples.
- Tumor sequencing – Next-generation genome sequencing will be used to obtain a molecular profile of individual cancer specimens.
- Precision Tumor Board – A multidisciplinary Precision Tumor Board with expertise in clinical oncology, clinical genetics, pathology, genomics, bioinformatics, genetic counseling, psychology and bioethics will assess sequencing results and provide study oversight. NOTE: Only results obtained in a CLIA-certified laboratory can be disclosed to patients and utilized for clinical decision making. In some instances, additional testing might be required and carried out by the study.
- Follow-Up – Study patients will be tracked at 4 months, 8 months, 12 months, 18 months (generally by chart review, not clinic visits) to collect clinical data for individuals with respect to disease recurrence, clinical responses and overall survival.
- Along with verifying a mechanism for the use of sequencing to make clinical decisions, this study will provide data for basic, translational and clinical research studies designed to teach surgeons to perform this new procedure.
At a Glance
Trial no.: OSU-13053 (NCT02090530)
Eligibility: Patients 18 years and older with a confirmed diagnosis of advanced or refractory cancer, any malignancy or tissue of origin; tumor must be suitable for research tumor biopsy; patients must be medically fit to undergo a tissue biopsy or surgical procedure to obtain tumor tissue; patients with multiple malignancies and patients with an inherited cancer syndrome or a medical history that suggests an inherited cancer syndrome.