Retrospective Data Pull of Tumor Mutational Burden and Related Information in Lung Carcinomas- An Outcomes Study

Grants and Contracts Details


HUMAN CLINICAL TRIAL -- CONFIDENTIAL Responsibility of study participation will include: - Successful subcontract agreement between institution and the University of Utah - Ethics clearance from site¡¦s institutional review board - Assignment of a project lead and study coordinator who will be the primary point of contact (may be the same person) - Participation in Site Kick Off meeting o Provide Pharmacotherapy Outcomes Research Center (PORC) estimated time to complete data abstraction o If >1 month anticipated to provide study data, establish with PORC study status check-in at agreed upon regular intervals, i.e. weekly, biweekly - Review study protocol provided by PORC o Identify study candidates who meet study eligibility as listed in protocol - Diagnosis of advanced (Stage IV, extensive) NSCLC or SCLC by ICD-9-CM, ICD-10-CM, ICD-O codes and verified by pathology reports or institutional tumor registry from 2012 to present. Appendices 1, 2, 4 and 9 in the Study Protocol list relevant ICD codes. - Age 18 years and older at time of diagnosis of NSCLC or SCLC - Comprehensive genomic profiling including TMB reporting completed from 2012-present - Treatment with any chemotherapy, targeted therapy, immunotherapy or radiation therapy for metastatic NSCLC or SCLC - At least 2 months (60 days) of follow-up data on treatment or death within two months (60 days) of treatment initiation o Extraction of clinical variables from institutional electronic health records of study participants. PORC will provide data collection tool.
Effective start/end date1/1/1912/31/19


  • University of Utah: $16,189.00


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