Protocol Index	

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OP RESEARCH PRO00037085 D926XC00001 SCREENING MAI	

Types:      Research Oncology Treatment
Synonyms:  

Cycle 1	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Miscellaneous
  	AMB REFERRAL TO OPHTHALMOLOGY	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	o Informed consent: main study 
o Written informed consent and any locally required privacy act document authorization must be obtained prior to performing any protocol-specific procedures, including screening/baseline evaluations
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Informed consent: genetic sample and analysis (optional)
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Inclusion and exclusion criteria
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Demography: Includes: age at screening, sex, race, ethnicity
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Full physical examination
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Medical history: Includes ocular history, pulmonary disease history, smoking history, type and frequency of tobacco use, e-cigarette use, Vaping (including dates).
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Past and current medical conditions
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o Assessment required within 7 days before C1D1. 
o Triplicate ECGs at screening. Whenever ECGs, vital signs and blood draws are scheduled for the same nominal time, ECG assessments should occur first, then vital signs assessments, and then blood draws; the timing of the first 2 assessments should be such that it allows the blood draw (eg, PK blood sample) to occur at the time points indicated in the SoA. Pulse oximetry will be performed at the same time as vital signs.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Oral care protocol: Daily oral care protocol before study intervention administration and maintained throughout the study.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse Events: All AEs will be recorded on the AE eCRF page
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Prior and concomitant medication
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --			Imaging
  	CT CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	HRCT if feasible; otherwise, non-contrast chest CT acceptable (1-2 mm slice thickness recommended)
			Imaging
  	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --	Comments:	o OR MUGA. Order if appropriate. 
o The same test(ECHO orMUGA) must be used for the Participant throughout the study.
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Verify Ejection Fraction prior to Cycle 1.  Ejection Fraction: ***% on *** (date).

If patient has not had a recent MUGA or ECHO, order one via order entry. A baseline cardiac evaluation with a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiac toxicity. Repeated MUGA or ECHO determinations of LVEF should be performed, particularly with higher, cumulative anthracycline doses.
			Nursing Orders
  	PULMONARY FUNCTION TEST	Interval: --	Occurrences: --			Labs
  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --		  	HEPATITIS C ANTIBODY	Interval: --	Occurrences: --			Imaging
◉	MAMMO BREAST SCREEN TOMOSYNTHESIS BILATERAL	Interval: --	Occurrences: --	Comments:	During study participation for participants with any remaining intact breast tissue (including male participants). The preferred tests are mammogram or MRI (MRI preferred for participants below 50 years of age). For participants who underwent a bilateral mastectomy, with no remaining breast tissue, a physical examination is sufficient and radiological tests are not mandatory. For participants who underwent a bilateral mastectomy, as well as for male participants, clinical exam may be supplemented by ultrasound exams at investigator's discretion. Within 1 year of randomization.
		◯	MRI BREAST WO CONTRAST BILATERAL	Interval: --	Occurrences: --	Comments:	During study participation for participants with any remaining intact breast tissue (including male participants). The preferred tests are mammogram or MRI (MRI preferred for participants below 50 years of age). For participants who underwent a bilateral mastectomy, with no remaining breast tissue, a physical examination is sufficient and radiological tests are not mandatory. For participants who underwent a bilateral mastectomy, as well as for male participants, clinical exam may be supplemented by ultrasound exams at investigator's discretion. Within 1 year of randomization.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Calculate creatinine clearance manually based on creatinine result
		  	HEPATIC FUNCTION PANEL	Interval: --	Occurrences: --		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --	Comments:	Free T3 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	Free T4 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system.
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	ONLY for women of child bearing age
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	If insufficient tissue is available from the residual invasive disease surgical specimen, tissue may be submitted from the diagnostic biopsy, pending approval by the Global Study Team.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --