Trial Information

Follow Up Protocol for Subjects Previously Enrolled in NCI Surgery Branch Studies

BACKGROUND:

- Patients receiving care at the NIH Clinical Center are required to be enrolled in a
clinical protocol

- Following participation in a treatment protocol, it may be in the best interest of the
patient to continue to be followed at the Clinical Center

- The NCI Surgery Branch conducts clinical trials utilizing gene transfer. The current
FDA requirements for long term follow up are up to fifteen years for some products. As
this time period is frequently longer than studies are expected to be open, a protocol
is necessary to ensure the necessary follow up of these subjects

OBJECTIVES:

-To provide long term follow up of patients previously enrolled on treatment protocols in
the NCI Surgery Branch

ELIGIBILITY:

-Enrollment on an NCI Surgery Branch treatment protocol

DESIGN:

-Patients will undergo physical exams, laboratory evaluation, imaging or phone follow up as
required by the treatment protocol and/or as clinically indicated.