Protocol Index	

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OP RESEARCH PRO00030489 HMCC-BR22-001 SCREENING ASSESSMENTS NIRAVATH	

Types:      Research Oncology Treatment
Synonyms:  

Cycle 1	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	CRC and treatment team to collect informed Consent. 
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Collect 
1. Inclusion/Exclusion Criteria. 
2. Demographics. 
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	CRC and treatment team to collect medical history. 
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Physical Exam will be performed at screening, before each cycle of iNOS inhibitor, nab-paclitaxel and alpelisib. Physical exam will include vital sign (blood pressure, oral or temporal temperature, pulse, and respiratory rate) and weight measurements. Height will be measured at screening only.
		  	MEASURE HEIGHT AND LENGTH	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	CRC and treatment team to collect ECOG performance status.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	CRC & Treating Team to Order 12-Lead ECGd if clinically indicated.
		  	ONC PROVIDER COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	MUGA scan or ECHO will be performed at screening and when clinically indicated for all patients. The same method (MUGA scan or ECHO) must be used throughout the duration of the trial. Please order if appropriate.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For WOCBP, serum ß-hCG pregnancy testing is to be performed at screening, and within 72 hours prior to initiation of each cycle of iNOS inhibitor, nab-paclitaxel and alpelisib. Serum ß-hCG pregnancy testing will be performed whenever an expected menstrual cycle is missed or when pregnancy is otherwise expected.
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --