DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
PUBLIC HEALTH SERVICE

NATIONAL INSTITUTES OF HEALTH
BETHESDA, MARYLAND 20014

 

NATIONAL CANCER INSTITUTE

May 15, 1974

Dr, Joshua Lederburg

Stanford University Medical Center
300 Pasteur Drive

Stanford, CA 94305

Dear Dr. Lederburg:

I would like to report to you on the site visit to your project
on April 26. There was general approval of your project and your
presentation. However, as a result of the consensus of the site
visitors, I would like to request that you send to me a clinical
proposal as soon as possible.

This proposal should indicate what type of patient with cancer will
be studied (it is likely that patients with fairly extensive tumors
but without fever, emaciation, anemia, uremia or malaise would be
the ideal types to be studied). It should indicate the prestudy
regimen (i.e., diet, drugs or other factors), how specimens will be
collected, how stored and other factors that would influence the
evaluation of specimen examination. Will multiple samples of urine
(24 hours) be studied? And if so, at what intervals?

The protocol should indicate how controls will be chosen. It is
suggested that controls should be of similar age, sex, weight, but
without evidence of cancer and studied in a manner similar to the
patients with cancer. Controls need not be "matched;" but if not,
then suitably randomized.

I would like to state that it was suggested that the emphasis should
be on quality rather than on quantity; perhaps groups of ten, all
with the same disease and approximate extent of the disease, who

are well studied, should form the basis of the clinical approach.
Dr. Lederburg - May 15, 1974
Page 2

Your request for a budgetary increase has been noted and trans-
mitted to the contract officer who by now probably has begun
negotiations.

I was sorry I was unable to accompany the other site visitors.
Perhaps at some time in the near future I will be able to visit
your project area.

Sincerely yours,

dy ee ie

William Pomerance, M.D.

Chief, Diagnosis Branch

Division of Cancer Biology and Diagnosis
National Cancer Institute