Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001983
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-01-26
Brief Title:
Eligibility Screening for National Institute of Dental and Craniofacial Research Studies
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Screening Protocol to Evaluate Patients for Approved Studies
Status:
COMPLETED
Status Verified Date:
2003-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 candidates participation in the screening program will terminate No experimental treatments are offered under the screening protocol
Patients who are found eligible for a current GTTB study will be notified of their options and invited to enroll
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 candidates participation in the screening program will terminate No experimental treatments are offered under the screening protocol
Patients who are found eligible for a current GTTB study will be notified of their options and invited to enroll
Detailed Description:
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 Sjogrens syndrome patients
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-D-0066 | None | None | None |