protocol go29294 a study evaluating a potential new treatment for locally advanced or metastatic...
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PROTOCOL GO29294A study evaluating a potential new treatment for locally advanced or metastatic urothelial bladder cancer
VERSION 1 | 19 SEPTEMBER 2014
PERSONAL VISIT SCHEDULE
GO29294_Personal_Visit Schedule_V1_19Sep2014
Useful Study Information
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This is your personal visit scheduledesigned to help preparing you for each study visit.
In case of any questions related to the (GO29294) Studyyou should contact:
Please remember to bring it with you each time you come to the clinic for your check up and consultations.
Number:
Name:
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What happens at the clinic visits?
Some assessments will be performed at each visit to the clinic. A list of all the assessments that will be performed during the course of the study is given below. Not every assessment will be performed at every visit.
Blood/UrineSamples
Blood and urine samples will be taken to monitor your health and to assess the effect of the drug.
Pregnancy Test
Pregnancy test will be performed for female patients ofchildbearing potential
QuestionnairesTwo written questionnaires on your UBC symptoms for you to answer. The questions will be asked face-to-face in an informal manner.
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What happens at the clinic visits?
Heart Assesment
PhysicalExamination
A physical examination will be performed that will include measuring your vital signs (blood pressure, pulse, body temperature), and recording your height and weight.
TissueSamples
Your study doctor will submit a tissue sample from your tumor excision or biopsy sample if available. Otherwise a new tumor biopsy will be required.
An ECG will be performed; ECG is the measurement of the electrical activity of your heart
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Radiologicalscans
All sites of your cancer will be scanned using computed tomography (CT) or magnetic resonance imaging (MRI).
Treatment Study Drug Infusion
What happens at the clinic visits?
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Your next visit
Visit Time ofnext visit
Date of your next visit:(dd/mmm/yyyy)
2 0
Location
2 0
2 0
2 0
2 0
2 0
2 0
2 0
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Your next visit | Procedures to be undertaken at your next visit:
Questionnaires Physicalexamination
Heart Assessment
Radiologicalscans
TreatmentPregnancyTest
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Blood /UrineSamples
TissueSamples
Visit
GO29294_Personal_Visit Schedule_V1_19Sep2014
Your next visit
Visit Time ofnext visit
Date of your next visit:(dd/mmm/yyyy)
2 0
Location
2 0
2 0
2 0
2 0
2 0
2 0
2 0
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Your next visit | Procedures to be undertaken at your next visit:
Questionnaires Physicalexamination
Heart Assessment
Radiologicalscans
TreatmentPregnancyTest
Blood /UrineSamples
TissueSamples
Visit
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Your next visit
Visit Time ofnext visit
Date of your next visit:(dd/mmm/yyyy)
2 0
Location
2 0
2 0
2 0
2 0
2 0
2 0
2 0
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Your next visit | Procedures to be undertaken at your next visit:
Questionnaires Physicalexamination
Heart Assessment
Radiologicalscans
TreatmentPregnancyTest
12
Blood /UrineSamples
TissueSamples
Visit
GO29294_Personal_Visit Schedule_V1_19Sep2014
Your next visit
Visit Time ofnext visit
Date of your next visit:(dd/mmm/yyyy)
2 0
Location
2 0
2 0
2 0
2 0
2 0
2 0
2 0
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Your next visit | Procedures to be undertaken at your next visit:
Questionnaires Physicalexamination
Heart Assessment
Radiologicalscans
TreatmentPregnancyTest
Blood /UrineSamples
TissueSamples
Visit
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Your next visit
Visit Time ofnext visit
Date of your next visit:(dd/mmm/yyyy)
2 0
Location
2 0
2 0
2 0
2 0
2 0
2 0
2 0
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Your next visit | Procedures to be undertaken at your next visit:
Questionnaires Physicalexamination
Heart Assessment
Radiologicalscans
TreatmentPregnancyTest
16
Blood /UrineSamples
TissueSamples
Visit
GO29294_Personal_Visit Schedule_V1_19Sep2014
Your next visit
Visit Time ofnext visit
Date of your next visit:(dd/mmm/yyyy)
2 0
Location
2 0
2 0
2 0
2 0
2 0
2 0
2 0
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Your next visit | Procedures to be undertaken at your next visit:
Questionnaires Physicalexamination
Heart Assessment
Radiologicalscans
TreatmentPregnancyTest
Blood /UrineSamples
TissueSamples
Visit
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NotesPlease note down anything you would like to mention to the nurse at your next visit:
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NotesPlease note down anything you would like to mention to the nurse at your next visit:
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GO29294 Study
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