APPENDIX H 
INFORMATION FOR PATIENTS AND FAMILIES CONCERNING THE 
KIDNEY CANCER PHASE I STUDY AT JOHNS HOPKINS 
INTRODUCTION 
The following detailed information might be of interest to 
you in thinking about taking part in this study. This information 
might help you and your family members raise further questions for 
the doctors to explain to you prior to deciding to participate in 
the study. Cancer patients and family members have helped us with 
wording. 
This study is a phase I study. A phase I study is a testing 
of side effects of a new experimental form of treatment. Because 
this treatment is experimental, and evaluation of side effects is 
the prime aim, no promises can be made that taking part in the 
study will help you in any way. Your participation is is 
voluntary. You can change your mind at any time, and continue your 
medical care at Johns Hopkins if you wish. You can choose also to 
take part later, if your health continues to make you eligible and 
the study is not finished. 
1 . SURGERY 
You would not be have been asked to think about taking part in 
this study at Johns Hopkins unless there was an abnormal growth (a 
tumor) in your kidney. You may already have had a needle biopsy by 
the time you came to see the doctors involved in this study 
indicating the presence of kidney cancer. Some patients, however, 
considering this study will not have had a needle biopsy 
recommended depending on their previous evaluation. Needle 
biopsies from a long needle inserted from the outside of your body 
into an area of abnormal growth on a X-ray or CT scan can cause 
uncontrolled bleeding in some cases. Kidney cancers have many 
small blood vessels which may not stop bleeding very quickly after 
the biopsy. Often the tissue diagnosis of the type of abnormal 
growth in the kidney is most safely made during an operation to 
remove the cancerous kidney where any bleeding after cancer tissue 
removal can be controlled by the surgeon. 
You are eligible to take part in this study because the 
doctors have already determined with examination and tests that 
given your otherwise excellent health surgery has low risks 
compared to the benefit of removing a cancerous kidney. Even if 
there were no phase I study, surgery in you particular case would 
be considered. You are welcome to get a second opinion regarding 
the surgery if you wish and still take part in the study afterward 
if you chose. In patients with health such as yours, the mortality 
rate (percent of all patients who die because of the surgery) at 
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