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OP RESEARCH PRO0035580-BR22 / TREATMENT	

Types:      Research Oncology Treatment
Synonyms:  BR22, BASELINE, SCREENING

V1,2,3	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Treatment V1 (Day 0): Cryoablation for 1-3 cycles of: freeze [6-10 minute]; thaw [6-10 minutes]; and freeze [6-10 minutes], each followed by 6-8 minutes of passive thaw. Additional Cryoablation treatment V2 and V3 will be at PIs discretion.
			Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Cryoablation Therapy

V1 (Day 0), V2 and V3 at PI discretion
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs and SAEs
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant Medications 

Collect medications received within 28 days before the start of trial treatment and 30 days after the dose of trial treatment should be recorded. Unless they are given for AEs or SAEs related to the treatment during the follow-up period
					
Month 3	Repeat 1 time	Cycle length: 90 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, temperature, pulse, and respiratory rate
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	RECIST 1.1 Disease Assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs and SAEs
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant Medications 

Collect medications received within 28 days before the start of trial treatment and 30 days after the dose of trial treatment should be recorded. Unless they are given for AEs or SAEs related to the treatment during the follow-up period
			Imaging
  	MAMMO BREAST SCREEN TOMOSYNTHESIS BILATERAL	Interval: --	Occurrences: --		  	US BREAST COMPLETE BILATERAL	Interval: --	Occurrences: --		  	SCINTIMAMMOGRAPHY	Interval: --	Occurrences: --			Procedures
  	BIOPSY BREAST	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	ALKALINE PHOSPHATASE	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 6	Repeat 1 time	Cycle length: 90 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, temperature, pulse, and respiratory rate
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	RECIST 1.1 Disease Assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs and SAEs
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant Medications 

Collect medications received within 28 days before the start of trial treatment and 30 days after the dose of trial treatment should be recorded. Unless they are given for AEs or SAEs related to the treatment during the follow-up period
			Imaging
  	MAMMO BREAST SCREEN TOMOSYNTHESIS BILATERAL	Interval: --	Occurrences: --		  	US BREAST COMPLETE BILATERAL	Interval: --	Occurrences: --		  	SCINTIMAMMOGRAPHY	Interval: --	Occurrences: --			Procedures
  	BIOPSY BREAST	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	ALKALINE PHOSPHATASE	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 12	Repeat 1 time	Cycle length: 180 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, temperature, pulse, and respiratory rate
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	RECIST 1.1 Disease Assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs and SAEs
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant Medications 

Collect medications received within 28 days before the start of trial treatment and 30 days after the dose of trial treatment should be recorded. Unless they are given for AEs or SAEs related to the treatment during the follow-up period
			Imaging
  	MAMMO BREAST SCREEN TOMOSYNTHESIS BILATERAL	Interval: --	Occurrences: --		  	US BREAST COMPLETE BILATERAL	Interval: --	Occurrences: --		  	SCINTIMAMMOGRAPHY	Interval: --	Occurrences: --			Procedures
  	BIOPSY BREAST	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	ALKALINE PHOSPHATASE	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 18	Repeat 1 time	Cycle length: 180 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, temperature, pulse, and respiratory rate
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	RECIST 1.1 Disease Assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs and SAEs
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant Medications 

Collect medications received within 28 days before the start of trial treatment and 30 days after the dose of trial treatment should be recorded. Unless they are given for AEs or SAEs related to the treatment during the follow-up period
			Imaging
  	MAMMO BREAST SCREEN TOMOSYNTHESIS BILATERAL	Interval: --	Occurrences: --		  	US BREAST COMPLETE BILATERAL	Interval: --	Occurrences: --		  	SCINTIMAMMOGRAPHY	Interval: --	Occurrences: --			Procedures
  	BIOPSY BREAST	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	ALKALINE PHOSPHATASE	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 24	Repeat 1 time	Cycle length: 180 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, temperature, pulse, and respiratory rate
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	RECIST 1.1 Disease Assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs and SAEs
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant Medications 

Collect medications received within 28 days before the start of trial treatment and 30 days after the dose of trial treatment should be recorded. Unless they are given for AEs or SAEs related to the treatment during the follow-up period
			Imaging
  	MAMMO BREAST SCREEN TOMOSYNTHESIS BILATERAL	Interval: --	Occurrences: --		  	US BREAST COMPLETE BILATERAL	Interval: --	Occurrences: --		  	SCINTIMAMMOGRAPHY	Interval: --	Occurrences: --			Procedures
  	BIOPSY BREAST	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	ALKALINE PHOSPHATASE	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 30	Repeat 1 time	Cycle length: 180 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, temperature, pulse, and respiratory rate
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	RECIST 1.1 Disease Assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs and SAEs
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant Medications 

Collect medications received within 28 days before the start of trial treatment and 30 days after the dose of trial treatment should be recorded. Unless they are given for AEs or SAEs related to the treatment during the follow-up period
			Imaging
  	MAMMO BREAST SCREEN TOMOSYNTHESIS BILATERAL	Interval: --	Occurrences: --		  	US BREAST COMPLETE BILATERAL	Interval: --	Occurrences: --		  	SCINTIMAMMOGRAPHY	Interval: --	Occurrences: --			Procedures
  	BIOPSY BREAST	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	ALKALINE PHOSPHATASE	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 36	Repeat 1 time	Cycle length: 365 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, temperature, pulse, and respiratory rate
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	RECIST 1.1 Disease Assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs and SAEs
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant Medications 

Collect medications received within 28 days before the start of trial treatment and 30 days after the dose of trial treatment should be recorded. Unless they are given for AEs or SAEs related to the treatment during the follow-up period
			Imaging
  	MAMMO BREAST SCREEN TOMOSYNTHESIS BILATERAL	Interval: --	Occurrences: --		  	US BREAST COMPLETE BILATERAL	Interval: --	Occurrences: --		  	SCINTIMAMMOGRAPHY	Interval: --	Occurrences: --			Procedures
  	BIOPSY BREAST	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	ALKALINE PHOSPHATASE	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 48	Repeat 1 time	Cycle length: 365 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, temperature, pulse, and respiratory rate
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	RECIST 1.1 Disease Assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs and SAEs
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant Medications 

Collect medications received within 28 days before the start of trial treatment and 30 days after the dose of trial treatment should be recorded. Unless they are given for AEs or SAEs related to the treatment during the follow-up period
			Imaging
  	MAMMO BREAST SCREEN TOMOSYNTHESIS BILATERAL	Interval: --	Occurrences: --		  	US BREAST COMPLETE BILATERAL	Interval: --	Occurrences: --		  	SCINTIMAMMOGRAPHY	Interval: --	Occurrences: --			Procedures
  	BIOPSY BREAST	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	ALKALINE PHOSPHATASE	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --