Grants and Contracts Details
Description
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.
Status | Finished |
---|---|
Effective start/end date | 1/1/19 → 12/31/19 |
Funding
- University of Utah: $16,189.00
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