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OP RSH PRO00037695 / HN009 / BASELINE / SCREENING	

Types:      Research Oncology Treatment
Synonyms:  HN009, BASELINE, SCREENING, PRO00037695

Baseline/Screening( up to 28 days)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Pathologically (histologically or cytologically) proven diagnosis of SCCHN of the oropharynx, larynx, hypopharynx, or p16-positive unknown primary
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Exam with laryngopharyngoscopy.

--Prior to Registration = 70 days
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	History/physical examination.

-Prior to Registration = 60 days
			Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Mandatory local confirmation of p16 status (OPC and CUP cases only)
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Smoking history
			Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	CT scan of neck OR MRI of the neck OR FDG-PET/CT of the neck --Prior to Registration = 60 days 

--diagnostic quality w/ contrast, unless contraindicated.
The CT component should be of diagnostic quality w/ contrast, unless contraindicated.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	FDG-PET/CT of the chest OR Chest CT 

-Prior to Registration = 60 days
			Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Zubrod (ECOG) performance status 

-Prior to Registration = 14 days
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Audiogram 

--(Including pure-tone averages by air and bone conduction, speech audiometry, and tympanometry); highly recommended. See Appendix II for details
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Adverse Event Evaluation
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	NSAID use
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Patient-Reported Outcomes

• FACT-H&N
• HHIA-S
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Patient History Form --(patient-reported); optional
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Specimen submissions for patients who consent to biobanking 

• H&E slide/FFPE tumor tissue
• Plasma
• Serum
• Whole blood
			Labs
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	include ANC, platelets, Hgb
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	include total bilirubin, AST, ALT, creatinine
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Urine or serum pregnancy test 
-for women with childbearing potential only
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --