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OP RSH PRO00043008 PURI HMCC-BR25-003 SCREENING/BASELINE	

Types:      Research Oncology Treatment
Synonyms:  

Screening/Baseline	Repeat 1 time	Cycle length: 28 days	Day -28 ( -28 to -7 days)	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    HMCC-BR25-003_Puri.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for T-DXD and Azeliragon Refer to Section 4.5 Protocol Access Hyperlink:   HMCC-BR25-003_Puri
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Informed consent
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Inclusion/Exclusion
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Demographics
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Medical History
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical Exam. Only screening procedures not performed within the screening period are required at baseline.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include weight, blood pressure, oral temperature, heart rate, respiratory rate measurements and height. Only screening procedures not performed within the screening period are required at baseline.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Obtain single local ECG.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collection of Archive Tissue. If applicable. If biopsy is performed for standard-of-care, additional tissue may be taken for the study or discard tissue can be used.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tissue Biopsy. Optional. Refers to patients who signed voluntary consent forms. A before treatment and after treatment tissue biopsy will be performed (+/- 2 weeks). If biopsy is performed for standard-of-care, additional tissue may be taken for the study or discard tissue can be used
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --				Day 7  ( -7 to -1 days)	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    HMCC-BR25-003_Puri.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for T-DXD and Azeliragon Refer to Section 4.5 Protocol Access Hyperlink:   HMCC-BR25-003_Puri
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include weight, blood pressure, oral temperature, heart rate, respiratory rate measurements and height. Only screening procedures not performed within the screening period are required at baseline.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Physical Exam. Only screening procedures not performed within the screening period are required at baseline.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30 Questionnaire
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	Baseline and as clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	Baseline and as clinically indicated.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of childbearing potential. If the screening serum pregnancy test is performed more than 7 days before dosing, it must be repeated at baseline, with results known to be negative prior to the administration of the first dose of study treatment. Baseline and as clinically indicated.
			Imaging
☑	ONC NURSING COMMUNICATION 68	Interval: Until discontinued	Occurrences: --	Comments:	If a scan has been completed within the last 2 weeks of screening that will be acceptable as baseline.
		☑	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --			Imaging
☑	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		☑	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Correlative Blood Collection. Blood will be collected into one 10 ml standard vacutainer tube (at least 1.5-2 mL per timepoint). Use green-top tubes (lithium or sodium heparin).