Protocol Index	

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OP RESEARCH PRO00037834 IDE196-002 / IND 143026 MAQSOOD SCREENING	

Types:      Research Oncology Treatment
Synonyms:  

Screening	Repeat 1 time	Cycle length: 21 days	Day -21	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	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:    IDE196-002
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Written Informed Consent: Informed consent is required prior to any protocol-specific procedures as described in Section 7.1.1.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Inclusion/exclusion criteria
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Demographic data
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Relevant medical history/current medical conditions
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior medication
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Diagnosis and disease history/ baseline disease characteristics
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	HLA-A*0201 Status Documentation
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Prior therapy for malignancy: Include neoadjuvant and /or adjuvant treatments: systemic therapies, ablations, radiation, and surgical intervention.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Investigator's choice of comparator: Document in IRT.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Tumor assessment: Imaging of the chest, abdomen, and pelvis (with IV contrast unless contraindicated and oral contrast per institutional standards) by CT or MRI is required. MRI of the abdomen is required unless MRI is contraindicated. CT is the preferred modality for imaging the chest. MRI of the brain is required at screening if known or suspected history of brain disease. All known sites of disease should be imaged by CT or MRI at baseline and followed on-study. See Section 7.2.1.2 for further details. 
The same imaging facility, modality and parameters should be used during the study.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Metastatic archival/fresh tumor tissue: If no archival tissue is available a fresh tumor FFPE sample will need to be provided.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events: AEs/SAEs are to be recorded following informed consent until 28 days after the last dose of study treatment
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant medications: Current medication is to be recorded following informed consent until 28 days after the last dose of study treatment.
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	First 15 participants at each dose regimen treated in Phase 2a, total N=30).12-lead electrocardiogram (Remaining Phase 2a, 2b and Phase 3 participants)
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	Post-screening, ONLY if clinically indicated.
		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	Post-screening, ONLY if clinically indicated.
		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	See Table 22 for a list of parameters.
Post-screening, only if clinically indicated. Specific gravity, pH, glucose, protein, ketones, and blood).
A standard microscopic evaluation should also be done with additional studies as clinically indicated.
		☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child bearing potential
		☑	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	See Table 22 for a list of parameters.
Post-screening, ONLY if clinically indicated. Thyroid stimulating hormone (reflexive thyroid hormone if abnormal) should be performed in screening and then as clinically indicated (if being treated with immunotherapy apply institutional guidelines).
If clinically indicated test for other endocrine deficiencies: morning serum cortisol, adrenocorticotropic hormone (ACTH), luteinizing hormone (LH), follicle stimulating hormone (FSH), testosterone, estradiol (premenopausal individuals), and cosyntropin stimulation test.
		☑	CORTISOL LEVEL, RANDOM	Interval: --	Occurrences: --	Comments:	IF clinically indicated.
		☑	ADRENOCORTICOTROPIC HORMONE	Interval: --	Occurrences: --	Comments:	IF clinically indicated.
		☑	FSH AND LH	Interval: --	Occurrences: --	Comments:	IF clinically indicated.
		☑	ESTRADIOL LEVEL	Interval: --	Occurrences: --	Comments:	IF clinically indicated for premenopausal individuals
		☑	TESTOSTERONE, TOTAL AND FREE, IMMUNOASSAY AND CALCULATION (FOR ADULT MALES)	Interval: --	Occurrences: --	Comments:	IF clinically indicated
		☑	TESTOSTERONE, TOTAL AND FREE, MASS SPECTROMETRY AND CALCULATION (FOR WOMEN, CHILDREN AND HYPOGONADAL MEN)	Interval: --	Occurrences: --	Comments:	IF clinically indicated
		☑	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Cosyntropin stimulation test IF clinically indicated. Order using Cosyntropin Injection therapy plan.
		☑	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --	Comments:	IF clinically indicated
		☑	HEPATITIS B CORE ANTIBODY IGM	Interval: --	Occurrences: --	Comments:	IF clinically indicated
		☑	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	IF clinically indicated. 
HBV DNA should be obtained prior to enrollment if participant has a negative serology for HBsAg and a positive serology for anti-HBcAb.
		☑	HEPATITIS C ANTIBODY	Interval: --	Occurrences: --	Comments:	IF clinically indicated
		☑	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	IF clinically indicated. 
HCV RNA should be obtained prior to randomization if participant tests positive for anti-HCV.
		☑	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --	Comments:	IF clinically indicated
			Imaging
  	CT CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Imaging of the chest, abdomen, and pelvis (with IV contrast unless contraindicated and oral contrast per institutional standards) by CT or MRI is required. MRI of the abdomen is required unless MRI is contraindicated. CT is the preferred modality for imaging the chest. MRI of the brain is required at screening if known or suspected history of brain disease. All known sites of disease should be imaged by CT or MRI at baseline and followed on-study. See Section 7.2.1.2 for further details.
The same imaging facility, modality and parameters should be used during the study.
		  	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Imaging of the chest, abdomen, and pelvis (with IV contrast unless contraindicated and oral contrast per institutional standards) by CT or MRI is required. MRI of the abdomen is required unless MRI is contraindicated. CT is the preferred modality for imaging the chest. MRI of the brain is required at screening if known or suspected history of brain disease. All known sites of disease should be imaged by CT or MRI at baseline and followed on-study. See Section 7.2.1.2 for further details.
The same imaging facility, modality and parameters should be used during the study.
		  	CT PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Imaging of the chest, abdomen, and pelvis (with IV contrast unless contraindicated and oral contrast per institutional standards) by CT or MRI is required. MRI of the abdomen is required unless MRI is contraindicated. CT is the preferred modality for imaging the chest. MRI of the brain is required at screening if known or suspected history of brain disease. All known sites of disease should be imaged by CT or MRI at baseline and followed on-study. See Section 7.2.1.2 for further details.
The same imaging facility, modality and parameters should be used during the study.
		  	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	Imaging of the chest, abdomen, and pelvis (with IV contrast unless contraindicated and oral contrast per institutional standards) by CT or MRI is required. MRI of the abdomen is required unless MRI is contraindicated. CT is the preferred modality for imaging the chest. MRI of the brain is required at screening if known or suspected history of brain disease. All known sites of disease should be imaged by CT or MRI at baseline and followed on-study. See Section 7.2.1.2 for further details.
The same imaging facility, modality and parameters should be used during the study.
				Day -14	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	ECOG performance status: Screening assessment must be obtained within 14 days of C1D1.
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Complete physical examination: Screening assessment must be obtained within 14 days of C1D1.
See Section 7.2.4.1 for further details
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --