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OP RSH PRO00041680 ABDELRAHIM HCC 23-116 SCREENING	

Types:      Research Oncology Treatment
Synonyms:  PRO00041680, ABDELRAHIM HCC 23-116

Baseline/Screening	Repeat 1 time	Cycle length: 28 days	Day -28	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:     HCC 23-116_Abdelrahim
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Zanzalintinib (XL-092) Treatment: Refer to Section 7.2.1.2  Protocol Access Hyperlink:    HCC 23-116_Abdelrahim
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Informed Consent
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Eligibility Review
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Medical History
		  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Review Medications
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical Exam. Height measured at screening/ baseline only. Physical exams include weight.
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Physical Exam. Height measured at screening/ baseline only. Physical exams include weight.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, respiratory rate, pulse, and oral or temporal temperature.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	PRO Evaluations
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Adverse Event assessment.Subjects will be monitored continuously for AEs while on study from the time of signing informed consent through 90 days after the date of the decision to permanently discontinue study treatment`
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Height measured at screening/ baseline only. Physical exams include weight.
Resting (obtained after the patient has been in a supine position for 5 minutes and recorded while the patient remains in that position) 12-lead ECGs will be recorded at the following timepoints:
I. Screening / baseline (triplicate): Mean QT interval corrected for heart rate (QTcF) > 470 ms calculated from 3 electrocardiograms (ECGs) within 15 minutes at 5 minutes apart using Fridericia's Correction.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Height measured at screening/ baseline only. Physical exams include weight.
Resting (obtained after the patient has been in a supine position for 5 minutes and recorded while the patient remains in that position) 12-lead ECGs will be recorded at the following timepoints:
I. Screening / baseline (triplicate): Mean QT interval corrected for heart rate (QTcF) > 470 ms calculated from 3 electrocardiograms (ECGs) within 15 minutes at 5 minutes apart using Fridericia's Correction.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Height measured at screening/ baseline only. Physical exams include weight.
Resting (obtained after the patient has been in a supine position for 5 minutes and recorded while the patient remains in that position) 12-lead ECGs will be recorded at the following timepoints:
I. Screening / baseline (triplicate): Mean QT interval corrected for heart rate (QTcF) > 470 ms calculated from 3 electrocardiograms (ECGs) within 15 minutes at 5 minutes apart using Fridericia's Correction.
			Imaging
☑	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Imaging - Chest, Abdomen and Pelvis (RECIST and imRECIST assessment). CT is preferred modality; MRI can be used if CT is contraindicated or at investigator discretion. Contrast should be used for all imaging per institutional practice unless contraindicated.
I. The same type of imaging used at screening must continue to be used throughout the study. (WINDOW: ± 4 DAYS)
		☑	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		☐	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		☐	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
			Imaging
☑	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT/MRI Brain to be performed at screening for participants with history of or suspected metastases to the brain.
		☐	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT/MRI Brain to be performed at screening for participants with history of or suspected metastases to the brain.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Window for hematology tests is ± 7 days for Day 1 of all treatment cycles; ±3 days for days 8, 15, and 22 in Cycles 1 & 2 and day 15 of all the subsequent cycles; and ±7 days for EOT evaluations. Basophils
Mean corpuscular volume ,Eosinophils
Monocytes ,Hematocrit,Neutrophils, Hemoglobin,Platelet count , Lymphocytes,Red blood cell count, Mean corpuscular hemoglobin,Total white cell count,Mean corpuscular hemoglobin concentration
			Labs
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	NOTE regarding serum chemistries during treatment: Only in cases where pneumonitis (ILD) is suspected during study treatment, per PI discretion, also do C-Reactive Protein (CRP) testing. Window for tests is ± 7 days for Day 1 of all treatment cycles; ±3 days for days 8, 15, and 22 in Cycles 1 & 2 and day 15 of all the subsequent cycles; and ±7 days for EOT evaluations 
Albumin,Gamma-glutamyl transferase (GGT),Alkaline phosphatase, Glucose,Amylase and Lipase, Lactate dehydrogenase (LDH),Aspartate aminotransferase, Magnesium, bicarbonate,Phosphorus, Calcium. Potassium, Chloride, Sodium,Creatinine, Total bilirubin, Urea or blood urea nitrogen (BUN),depending on local practice,Total protein
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	TSH, Free T3 and Free T4 required at screening. Perform Free T3 and Free T4 only if TSH is abnormal at subsequent timepoints.
		  	T3	Interval: --	Occurrences: --	Comments:	TSH, Free T3 and Free T4 required at screening. Perform Free T3 and Free T4 only if TSH is abnormal at subsequent timepoints.
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	TSH, Free T3 and Free T4 required at screening. Perform Free T3 and Free T4 only if TSH is abnormal at subsequent timepoints.
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Infectious disease tests.Infectious disease lab tests at screening/baseline only to include:
I. Tuberculosis (testing to be done only if suspicion of TB per clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice).
II. For hepatitis and HIV labs, draw if known history, suspected or in line with local practice: HBsAg, Hep B Core AB, HCV antibodies, and HIV 1/2. HCV RNA is to be drawn if HCV is positive.
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Tumor Markers (AFP).At the discretion of the physician every 6 weeks.
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Bilirubin, Ph, Blood, Protein,Glucose, Specific gravity,Ketones, Urine Protein/Creatinine Ratio,Color and appearance
			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.serum test will be conducted for participants who are women of childbearing potential (WOCBP) on the first treatment day of the first cycle (C1D1), while a highly sensitive urine test can be used at all other treatment visit during study drug administration
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	serum test will be conducted for participants who are women of childbearing potential (WOCBP) on the first treatment day of the first cycle (C1D1), while a highly sensitive urine test can be used at all other treatment visit during study drug administration
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Correlative Tumor Biopsy/Archival tissue
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Blood sample collection for future research