This screening protocol is designed to evaluate patients for participation in clinical
studies in the Gene Therapy and Therapeutics Branch (GTTB) of the National Institute of
Dental and Craniofacial Research. To participate, patients must meet the specific
requirements of at least one of the available research studies; this protocol serves as a
first step for admitting patients to an appropriate program.
People with diagnosed or undiagnosed conditions may participate in this screening protocol.
They will undergo procedures that may include questionnaires, a physical examination,
routine laboratory tests, and diagnostic imaging or radiological studies. Eligibility
screening will be limited to three visits within 12 months of entry into the protocol. If
an appropriate study is not found by the end of this time, the candidate's participation in
the screening program will terminate. No experimental treatments are offered under the
Patients who are found eligible for a current GTTB study will be notified of their options
and invited to enroll.
This protocol is designed to screen patients with either diagnosed or undiagnosed
conditions, and provides for determining eligibility for approved protocols within the Gene
Therapy and Therapeutics Branch (GTTB), National Institute of Dental and Craniofacial
Research. The purpose of the protocol is to allow evaluation of patients who do not meet
the requirements for other screening protocols, such as the screening protocol for Sjogren's
Each subject will be evaluated to determine whether they are suitable candidates for
inclusion in any protocols in the GTTB. The screening evaluation will include past and
current medical history, and an appropriate physical examination. Further routine
diagnostic tests may also be performed to determine eligibility for approved studies. The
tests and procedures are of minimal risk. When the screening has been completed, subjects
will be informed of the options available at the time for participation in available,
approved research protocols.
All patients who may be eligible for other currently approved protocols.
Inclusion and exclusion criteria will vary according to the protocol(s) for which the
patient is being screened.
Patients may be eligible if they have rare, unusual, interesting or unknown conditions
that require diagnosis.