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OP RSH PRO00046058 NRG-GI012 TRAN SCREENING	

Types:      Research Oncology Treatment
Synonyms:  PRO00046058 NRG-GI012

Prior to Step 1 Registration	Repeat 1 time	Cycle length: 31 days	Prior to Registration	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:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Diagnosis of HCC
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	History and physical exam
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Documentation of underlying liver disease. Including cirrhosis, Hepatitis history [Hepatitis B and Hepatitis C status, hemochromatosis, alcohol, autoimmune disease, or metabolic dysfunction associated steatohepatitis (MASH)
				Less than or Equal to 30 Days	Perform every 1 day x1			Research tolerance: -0/+0 days	Imaging
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Degree of Macrovascular Invasion. (see Appendix II)
			Imaging
☑	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Multiphasic liver CT and/or multi-phasic liver MRI. After EOT every 3 months for 2 years, every 6 months for 3 years, then annually.
		☑	CT ABDOMEN WWO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN PELVIS W WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --			Imaging
☑	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	CT chest and CT or MRI pelvis, or PET/CT chest/abdomen/pelvis
		☑	CT CHEST W CONTRAST	Interval: --	Occurrences: --		☐	CT CHEST WO CONTRAST	Interval: --	Occurrences: --		☐	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Scan
		☐	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Scan
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Scan
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor Scan
		☐	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --			Labs
  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	PLATELET COUNT	Interval: --	Occurrences: --		  	HEMOGLOBIN	Interval: --	Occurrences: --		  	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: --	Occurrences: --		  	ALT+AST	Interval: --	Occurrences: --		  	ALPHA FETOPROTEIN	Interval: --	Occurrences: --			Labs
◉	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Pregnancy (serum or urine).For women of child-bearing potential.
		◯	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Pregnancy (serum or urine).For women of child-bearing potential.
				Less than or Equal to 14 Days	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance status
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Child Pugh Score. (See Appendix III)
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	mALBI Score. (See Appendix IV)
			Labs
  	ALBUMIN LEVEL	Interval: --	Occurrences: --		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --					
Prior to Treatment	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	FACT-Hep. In person preferred; may be conducted by telehealth visit at the discretion of the site-identified qualified healthcare professional. Please see Section 11 for PRO administration guidelines and VisionTree Optimal Care registration (VTOC) instructions. This study uses VTOC for participants who elect to complete PRO assessments after baseline. See Appendix I, Best Practices for Collecting Patient Reported Outcomes (PROs) via Telephone or Mail.
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. In person preferred; may be conducted by telehealth visit at the discretion of the site-identified qualified healthcare professional. Please see Section 11 for PRO administration guidelines and VisionTree Optimal Care registration (VTOC) instructions. This study uses VTOC for participants who elect to complete PRO assessments after baseline. See Appendix I, Best Practices for Collecting Patient Reported Outcomes (PROs) via Telephone or Mail.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	H&E slide(s) and FFPE block from primary or metastatic site tumor tissue. Ship FFPE within 30 days from patient registration.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA WB01. 5-10 mL of anticoagulated whole blood in purple top EDTA tube, mix, aliquot, and store frozen at -80°C.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	SERUM SB01. 5-10 mL of whole blood in one (1) red-top tube, process, aliquot, and store frozen at -80°C.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	PLASMA PB01. 8-10 mL of whole blood collected in one (1) 10 mL Streck Nucleic Acid blood tube, process, aliquot, and store frozen at -80°C