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OP RSH PRO00040158 PRATH A032201 SCREENING	

Types:      Research Oncology Treatment
Synonyms:  A032201, PRATH, PRO00040158, KEYTRUDA, TIVOZANIB

Screening	Repeat 1 time	Cycle length: 28 days	-28 Days	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER 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:   A032201_Prath
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for TIVOZANIB Treatment: Refer to Section 10.2[RA1]   Management of AEs Associated with Refer to section  8.2
Protocol Access Hyperlink:  A032201_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 116	Interval: --	Occurrences: --	Comments:	Medical history
			Nursing Orders
  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Physical Exam

Physical examination and staging scans are required every 16w (+/-2w) for year 1 and 2 after registration; then every 24w (+/-3w)until 5 years from registration or until disease progression, or consent withdrawal, whichever comes first; thereafter, survival information is required every 12 months(+/-2 months) until 10 years from registration.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications
			Imaging
◯	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	MRI or CT
		◯	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	MRI or CT
		◯	CT HEAD WO CONTRAST	Interval: --	Occurrences: --	Comments:	MRI or CT
		◉	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	MRI or CT
		◯	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	MRI or CT
		◯	MRI BRAIN WO CONTRAST	Interval: --	Occurrences: --	Comments:	MRI or CT
			Imaging
☑	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI 

CT pelvis is as clinically indicated . Imaging scans (with or without contrast) will be obtained prior to registration and then every 12 weeks +/- 2 weeks during the first year, and then every 16 weeks, +/- 3 weeks for second year, every 24 weeks +/- 3 weeks for 3 years , then annually +/-4 weeks until 5 years after registration or progression , whichever comes first. Imaging beyond 5 years is recommended as clinically indicated .
		☐	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI 

CT pelvis is as clinically indicated . Imaging scans (with or without contrast) will be obtained prior to registration and then every 12 weeks +/- 2 weeks during the first year, and then every 16 weeks, +/- 3 weeks for second year, every 24 weeks +/- 3 weeks for 3 years , then annually +/-4 weeks until 5 years after registration or progression , whichever comes first. Imaging beyond 5 years is recommended as clinically indicated .
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI

CT pelvis is as clinically indicated . Imaging scans (with or without contrast) will be obtained prior to registration and then every 12 weeks +/- 2 weeks during the first year, and then every 16 weeks, +/- 3 weeks for second year, every 24 weeks +/- 3 weeks for 3 years , then annually +/-4 weeks until 5 years after registration or progression , whichever comes first. Imaging beyond 5 years is recommended as clinically indicated .
		☐	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI 

CT pelvis is as clinically indicated . Imaging scans (with or without contrast) will be obtained prior to registration and then every 12 weeks +/- 2 weeks during the first year, and then every 16 weeks, +/- 3 weeks for second year, every 24 weeks +/- 3 weeks for 3 years , then annually +/-4 weeks until 5 years after registration or progression , whichever comes first. Imaging beyond 5 years is recommended as clinically indicated .
			Nursing Orders
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	Tumor Tissue 

Submit archival tissue (from both primary and metastatic sites if possible)
			Nursing Orders
  	ONC NURSING COMMUNICATION 72	Interval: --	Occurrences: --	Comments:	FSKI-19/PROMIS-Fatigue/EQ-5D-5L

For patients registered to A032201-HO1
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE HEIGHT AND LENGTH	Interval: --	Occurrences: --			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	CALCIUM LEVEL	Interval: --	Occurrences: --			Labs
  	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: --	Occurrences: --			Labs
◯	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum Pregnancy 

For women of childbearing potential only. At baseline , testing must include a highly sensitive serum beta HCG test. All other visits , serum or urine HCG can be used . WOCB require a negative pregnancy test within either 24 hours (urine ) or 72 hours (serum) before dispensing or infusing study drug .
		◉	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Serum Pregnancy

For women of childbearing potential only. At baseline , testing must include a highly sensitive serum beta HCG test. All other visits , serum or urine HCG can be used . WOCB require a negative pregnancy test within either 24 hours (urine ) or 72 hours (serum) before dispensing or infusing study drug .
			Labs
◉	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	All patients will have urinalysis or UPCR performed at screening; if urine protein is >=2+, 24-hour urine collection or UPC ratio will be required . If UPCR <2, optimize blood pressure and manage per institutional guidelines .
		◯	URINE PROTEIN/CREATININE RATIO, RANDOM	Interval: --	Occurrences: --	Comments:	All patients will have urinalysis or UPCR performed at screening; if urine protein is >=2+, 24-hour urine collection or UPC ratio will be required . If UPCR <2, optimize blood pressure and manage per institutional guidelines .