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Protocol No. UW17120

Principal Investigator Burkard, Mark

Phase N/A

Age Group Adult

Scope National

Sponsor Type Industry

Title An Observational Study Profiling Biospecimens from Cancer Patients to Screen for Molecular Alterations (STRATA)

Objective As our understanding of the genomic landscape of cancer continues to improve, drug development strategies are increasingly targeting defined genetic sub-populations to identify improved responders. Cancer patients and their providers are often unaware there may be opportunities for eligibility assessments for potentially life-saving genomically-guided clinical trials and approved targeted therapies. Strata Oncology is initiating the Strata Trial (STR-001-001) with the primary goal of understanding the proportion of subjects available for clinical trials and approved targeted therapies in advanced and/or aggressive cancers while assessing the feasibility of using a large-scale next generation sequencing (NGS) screening program to match subjects for eligibility assessments in clinical trials and/or for approved targeted therapies.

Treatment The Strata test is an NGS-based assay which assesses a set of actionable and pre-defined somatic genetic alterations. A determination as to whether or not their tumors have genetic alterations which are associated with an affiliated therapeutic protocol and/or approved therapy will be made and the resulting report will be generated within 10 working days of receipt of materials.

Description The provider, investigator and/or study staff are responsible for interpreting the report in conjunction with other clinical information and communicating the results to the subject, as appropriate. When a match has been identified, a report (using the Strata Trial subject identification number to protect patient privacy) will be provided to the pharma partner alerting them to the potentially matched subject..

Key Eligibility
  • Subjects must be ≥ 18 years of age
  • Subjects must have histologically documented solid tumors or lymphoma
  • Subjects with glioblastoma or pancreatic cancer are eligible at any stage of disease
  • Subjects with lung cancer are eligible at Stage IIIB and stage IV, or with metastatic disease
  • Subjects with rare tumors (i.e. cancer started in an unusual place in the body, it is unusual type and requires special treatment) are eligible at stages II-IV
  • Subjects with lymphoma must have advanced disease refractory to standard curative therapy or have contraindication to standard therapy
  • Subjects with other solid tumors must have metastatic or incurable disease
  • Subjects must have an adequate formalin-fixed paraffin-embedded tumor specimen for genomic sequencing

Applicable Disease Sites Anal; Any Site; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Hematologic cancers, other; Ill-Defined Sites; Kidney; Leukemia; Liver; Lung; Lymphoma; Melanoma/Skin cancer; Multiple Myeloma; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

Status Open

Participating Institutions Johnson Creek, UW Cancer Center; UW Hospital and Clinics; UWCCC 1 South Park