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OP RSH PRO00044052 NIRAVATH BC-IMT-04 SCREENING	

Types:      Research Oncology Treatment
Synonyms:  PRO00044052 NIRAVATH BC-IMT-04

Baseline/Screening	Repeat 1 time	Cycle length: 28 days	Week -4 to -1	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:   BC-IMT-04_Niravath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for TPC Treatment: Refer to Section 8.1.3.3
Protocol Access Hyperlink:  BC-IMT-04_Niravath
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for SV-BR-1-GMTreatment: Refer to Section 6.4.1
Protocol Access Hyperlink: BC-IMT-04_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Informed consent
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Inclusion/Exclusion Criteria
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Medical history (including pathology and genomic analysis of metastatic lesion)
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Comprehensive physical examination. The comprehensive physical examination will include the following organ or body system assessments: skin (including chest wall and breast); head, eyes, ears, nose, and throat; thyroid; lungs; cardiovascular system; abdomen (liver, spleen); extremities; lymph nodes (including cervical, supraclavicular, axillary, epitrochlear and inguinal nodes); and a brief neurological examination.
		  	ECG 12-LEAD	Interval: --	Occurrences: --		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include blood pressure, heart rate, respiratory rate, and body temperature) will be taken with the subject in the recumbent, semi recumbent, or sitting position after 5 minutes of rest.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Prior/concomitant medications.To include all prior cancer therapies (regardless of timing) and all recent prescription and OTC medications (within 3 months of starting the study through the Follow-Up Visit).
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Adverse event assessment. All AEs that occur after any patient/subject has been enrolled, before treatment, during treatment, or within 28 days following the last dose of study treatment, whether or not they are related to the study, must be recorded on CRF and reported to the Sponsor.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Tumor Assessment. Tumor assessments either SOC or study related, must be performed at baseline during the Screening period, within 4 weeks of initiating dosing, then following inoculations during periodic assessments every 6 weeks (+/-7 calendar days) for the first 12 weeks and every 8 weeks (+/-7 calendar days) thereafter. Please note that all periodic assessments should begin from Cycle 1, Day 1 (C1D1).
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Quality of Life EORTC Questionnaires and Performance Status (ECOG). EORTC QLQ-30 and QLQ-BR45
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Hemoglobin Hematocrit Platelet count
Red blood cell count White blood cell count
Mean corpuscular hemoglobin Mean corpuscular hemoglobin concentration
Mean corpuscular volume Mean platelet volume
Red blood cell distribution width
Differential count, Including (% and/or absolute):
Basophils Eosinophils Lymphocytes Monocytes Neutrophils
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LACTATE DEHYDROGENASE (LDH)	Interval: --	Occurrences: --			Labs
  	TROPONIN T	Interval: --	Occurrences: --		  	NT-PROBNP	Interval: --	Occurrences: --			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --			Labs
  	TSH AND FREE T4	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	CORTISOL LEVEL, AM	Interval: --	Occurrences: --		  	ADRENOCORTICOTROPIC HORMONE	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential. Serum pregnancy test required at Screening and Follow-up.
			Labs
  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV) ANTIBODY WITH REFLEX TO PCR	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tumor Markers. Tumor markers include CEA , CA 27.29 , CA 15-3 will be tested at screening, every treatment cycle, periodic assessment and end of treatment (EOT) visit.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Central Lab exploratory assessment . (CellSave Kit) For CellSave Kit, 1 CellSave preservation tube (~10 mL) collected during the following 2 visits ONLY: baseline (Cycle 1) and first periodic assessment, preferably C3 during clinic visit. TPC ARM