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OP PRO00038634  WO44263 / BIOMARKER SCREENING	

Types:      Research Oncology Treatment
Synonyms:  BASELINE, SCREENING, WO44263

Biomarker Screening	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Informed Consent.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Demographics
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Disease information for CDx
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Pretreatment tumor tissue sample for biomarkers

If no archival tissue, a newly collected pretreatment tumor biopsy is required
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Determination of HER2 status by central testing
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Determination of PIK3CA mutation status by central testing
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Plasma sample for RBR; optional

Consent collected during biomarker screening
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Tumor biopsy 

Required if no archival tissue is available for 'pretreatment tumor tissue sample for biomarkers' assessment.