Clinical, Laboratory and Epidemiologic Pilot Studies of Individuals at High Risk for Viral-Associated Cancers
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. Confidentially of the
 information that is obtained is carefully protected. The results of the study are summarized
 for publication in the peer review literature.
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.
-  INCLUSION CRITERIA:

 Family or personal medical history of neoplasia of an unusual type, pattern, or number.

 Known or suspected factor(s) predisposing to neoplasia, such as environmental exposure
 (particularly immunological or virological), genetic or congenital factors (Mendelian
 traits predisposing to neoplasia, birth defects, and chromosomal anomalies), or unusual
 demographic features.