PROTOCOL GO29294 A study evaluating a potential new treatment for locally advanced or metastatic urothelial bladder cancer VERSION 1 | 19 SEPTEMBER 2014.

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Presentation transcript:

PROTOCOL GO29294 A 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 2 GO29294_Personal_Visit Schedule_V1_19Sep2014

This is your personal visit schedule designed to help preparing you for each study visit. In case of any questions related to the (GO29294) Study you should contact: Please remember to bring it with you each time you come to the clinic for your check up and consultations. Number: Name: 3 GO29294_Personal_Visit Schedule_V1_19Sep2014

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/Urine Samples 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 of childbearing potential Questionnaires Two written questionnaires on your UBC symptoms for you to answer. The questions will be asked face-to-face in an informal manner. GO29294_Personal_Visit Schedule_V1_19Sep2014 4

What happens at the clinic visits? Heart Assesment Physical Examination A physical examination will be performed that will include measuring your vital signs (blood pressure, pulse, body temperature), and recording your height and weight. Tissue Samples 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 GO29294_Personal_Visit Schedule_V1_19Sep2014 5

Radiological scans 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? 6 GO29294_Personal_Visit Schedule_V1_19Sep2014

Your next visit Visit Time of next visit Date of your next visit: (dd/mmm/yyyy) 20 Location GO29294_Personal_Visit Schedule_V1_19Sep2014

Your next visit | Procedures to be undertaken at your next visit: Questionnaires Physical examination Heart Assessment Radiological scans Treatment Pregnancy Test 8 Blood /Urine Samples Tissue Samples Visit GO29294_Personal_Visit Schedule_V1_19Sep2014

Your next visit Visit Time of next visit Date of your next visit: (dd/mmm/yyyy) 20 Location GO29294_Personal_Visit Schedule_V1_19Sep2014

Your next visit | Procedures to be undertaken at your next visit: Questionnaires Physical examination Heart Assessment Radiological scans Treatment Pregnancy Test Blood /Urine Samples Tissue Samples Visit 10 GO29294_Personal_Visit Schedule_V1_19Sep2014

Your next visit Visit Time of next visit Date of your next visit: (dd/mmm/yyyy) 20 Location GO29294_Personal_Visit Schedule_V1_19Sep2014

Your next visit | Procedures to be undertaken at your next visit: Questionnaires Physical examination Heart Assessment Radiological scans Treatment Pregnancy Test 12 Blood /Urine Samples Tissue Samples Visit GO29294_Personal_Visit Schedule_V1_19Sep2014

Your next visit Visit Time of next visit Date of your next visit: (dd/mmm/yyyy) 20 Location GO29294_Personal_Visit Schedule_V1_19Sep2014

Your next visit | Procedures to be undertaken at your next visit: Questionnaires Physical examination Heart Assessment Radiological scans Treatment Pregnancy Test Blood /Urine Samples Tissue Samples Visit 14 GO29294_Personal_Visit Schedule_V1_19Sep2014

Your next visit Visit Time of next visit Date of your next visit: (dd/mmm/yyyy) 20 Location GO29294_Personal_Visit Schedule_V1_19Sep2014

Your next visit | Procedures to be undertaken at your next visit: Questionnaires Physical examination Heart Assessment Radiological scans Treatment Pregnancy Test 16 Blood /Urine Samples Tissue Samples Visit GO29294_Personal_Visit Schedule_V1_19Sep2014

Your next visit Visit Time of next visit Date of your next visit: (dd/mmm/yyyy) 20 Location GO29294_Personal_Visit Schedule_V1_19Sep2014

Your next visit | Procedures to be undertaken at your next visit: Questionnaires Physical examination Heart Assessment Radiological scans Treatment Pregnancy Test Blood /Urine Samples Tissue Samples Visit 18 GO29294_Personal_Visit Schedule_V1_19Sep2014

Notes Please note down anything you would like to mention to the nurse at your next visit: 1919 GO29294_Personal_Visit Schedule_V1_19Sep2014

Notes Please note down anything you would like to mention to the nurse at your next visit: 20 GO29294_Personal_Visit Schedule_V1_19Sep2014

GO29294 Study 21 GO29294_Personal_Visit Schedule_V1_19Sep2014