Trial Information

Clinical, Laboratory and Epidemiologic Pilot Studies of Individuals at High Risk for Viral-Associated Cancers

This protocol presents the rationale, 25-year historical review, and methods for
multidisciplinary, low-risk studies of individuals referred to the NCI Viral Epidemiology
Branch (VEB). Referrals are generally for unusual types of cancer or related conditions,
known, or suspected to be related to viruses. Kaposi's sarcoma in two homosexual men
evaluated in 1981 is a classic example. These referral cases provide the basis for pilot
studies that generate hypotheses, the development of protocols for formal investigations of
promising leads, and help to set priorities for VEB.

A VEB investigator who is a Staff Member at the NIH Clinical Center, interviews each
subject, performs a physical examination, draws a blood sample, and, when appropriate for
the disease or virus under study, obtains other clinically indicated biological specimens,
such as urine, sputum, saliva, tears, semen, Pap smear, or cervical, anal, oral, or nasal
swabs. On occasion, other relatively non-invasive studies may be indicated. Skin testing
with conventional, licensed antigens for assessment of cellular immunity may be performed,
and skin lesions may be biopsied or excised. Tumor or other tissue biopsies may be obtained
when biopsy or surgery is clinically indicated for other reasons. Otherwise no surgery is
performed, and no therapy is administered. Clinical referral to other components of NCI,
NIH, or the private sector are made as needed. The biological specimens are frozen or
otherwise preserved to be batch tested in current assays or future assays that will be
developed. Such laboratory testing is performed either at VEB's own support laboratory, or
collaboratively in other NCI, NIH, or extramural laboratories that have the needed expertise
for the disease or virus under study.

Occasionally, repeated or more long-term evaluation is required. More often, a single
evaluation in the NIH outpatient clinic, or either at a collaborating physician's office or
other suitable site in the field, is sufficient. The VEB investigator provides counseling
relevant to the virus or disease under study, and about the interim study results. He or
she makes appropriate referral if needed (e.g., to the Genetic Epidemiology Branch for
genetic counseling). Clinically relevant results and the VEB investigator's interpretation
of these results, are provided in writing to the subject's primary caregiver.
Confidentiality of the information that is obtained is carefully protected. The results of
the study are summarized for publication in the peer review literature.