Swedish Cancer Institute Personalized Medicine Research Program
Over the years, cancer researchers and specialists are learning that not all cancers are alike and each cancer has its own unique features. Use of molecular testing is rapidly increasing to identify these unique features and to guide the best cancer treatment options. To improve cancer care it is important to evaluate the molecular information of cancer with a person’s other clinical information.
The SCI Personalized Medicine Research Program (PMRP) will enroll patients who have had, or are planning to have, molecular testing of their cancer as part of their clinical care. The SCI PMRP study asks your permission to collect and study information that has been generated during the course of your clinical care to:
1) Determine if molecular information helps in selecting the best treatment for your cancer.
2) Identify clinical trials, which study whether certain medications might provide better treatment and be safer for people with cancer that could be used for your treatment.
3) Identify new markers (substances in the body such as genetic materials and proteins related to the cancer) that might predict how people with cancer will do over time, to include how they might respond to cancer treatments.
Thomas Brown, MD
Swedish Cancer Institute
Each of the criteria in the following section must be met in order for a patient to be considered eligible for registration. Patients must meet the following criteria:
1. Patients with active malignancies, prior malignancies or selected pre-malignant conditions to include, but not limited to: myelo-dysplastic syndromes (MDS), actinic keratosis, Barrett’s esophagus, cervical dysplasia, colonic polyps, lung metaplasia, and oral leukoplakia.
2. 18 years of age, or older.
3. ECOG performance status of 0 to 2.
4. A candidate for anti-cancer therapy.
5. Life expectancy of at least three months.
6. Measurable or evaluable disease is not required; e.g. patients in the adjuvant setting may be enrolled, if clinically appropriate.
7. Prior malignancy or multiple current malignancies allowed.
8. Patients who previously had gene sequencing are allowed.
A variety of NGS assays and platforms for profiling cancers are commercially available through CellNetix and other laboratories. Although the aim is to enroll participants early in their disease course, and before tumor sequencing has been performed, patients who have undergone prior sequencing will also be allowed to enroll, provided the results of their molecular profiling data are available and interpretable for the aims of this study. Additional profiling using the SCI PMP Panel test will be performed only as clinical indicated, or to ensure the full range of panel genes has been sequenced.
9. All patients must be informed of the investigational nature of this study, and must give written informed consent, in accordance with institutional and federal guidelines. (Informed consent and research authorization will be available in English at initial study activation, with the consent form translated to other languages as the need arises.)
1. Patients who are not able to understand and consent for themselves to the PMRP.
2. Patients who do not have sufficient tissue available for the PMP Panel.