Brief Title
Gene Therapy Follow up for Subjects Previously Enrolled in NCI Genitourinary Malignancies Branch or Experimental Transplantation and Immunology Branch Studies
Official Title
Gene Therapy Follow up Protocol for Subjects Previously Enrolled in NCI Genitourinary Malignancies Branch or Experimental Transplantation and Immunology Branch Studies
Brief Summary
Background: Gene therapy is closely followed by the U.S. Food and Drug Administration (FDA). The FDA requires researchers to conduct long-term follow-up of people who have had the treatment. This study collects data on people who have had gene therapy and sends it to the FDA. The data does not include participants names. Objective: To contact current or past participants of gene therapy protocols at least once a year for up to 15 years to ensure they have not had any harmful side effects. Eligibility: People aged 18 and older who have had gene therapy in a National Cancer Institute Experimental Transplantation and Immunology Branch study Design: Participants will give their address and telephone number. They will also give and the address and phone number of 1 or 2 other people who will know where they are. For the first year after gene therapy, participants will give blood samples 3 times (at 3, 6, and 12 months). For the next 4 years, they may have a physical exam and laboratory tests with a home physician. They will get a kit to mail in blood samples. Or they can visit the NIH Clinical Center. They will be asked if they have had any signs of neurological, autoimmune, or blood disorders, or any new cancers. For years 6 to 15, participants will be contacted yearly via phone or email and asked questions about their health. They may give blood samples. When the participant dies, if researchers think the death was caused by gene therapy, they will ask the participant s family to allow an autopsy.
Detailed Description
Background: The NCI GMB/ETIB conducts clinical trials utilizing gene transfer. The current FDA requirements for long term follow up may be 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 facilitate collection of long term follow up information on subjects who have participated in gene transfer studies as required by the U.S. Food and Drug Administration and other regulatory groups Eligibility: Enrollment on a NCI GMB or ETIB treatment protocol for gene therapy. Design: Patients will undergo physical exams, laboratory evaluations and/or phone follow up as required by the treatment protocol and/or as clinically indicated.
Study Type
Observational
Primary Outcome
To provide long term follow up of patients previously enrolled on treatment protocols in the NCI ETIB Branch.
Condition
Cervical Intraepithelial Neoplasia
Study Arms / Comparison Groups
Cohort 1
Description: Subjects who have received treatment on an NCI GMB/ETIB or GMB gene therapy protocol.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
1000
Start Date
May 8, 2020
Completion Date
October 1, 2050
Primary Completion Date
October 1, 2035
Eligibility Criteria
- INCLUSION CRITERIA: - Subjects who have received gene therapy on an applicable NCI GMB/ETIB protocol. Age greater than or equal to 18 years. Note: Children are generally excluded from GMB/ETIB gene therapy studies and inclusion on this follow-up study will be limited to 18 years and older. EXCLUSION CRITERIA: -Children
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Scott M Norberg, D.O., (240) 760-6163, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04266093
Organization ID
200051
Secondary IDs
20-C-0051
Responsible Party
Sponsor
Study Sponsor
National Cancer Institute (NCI)
Study Sponsor
Scott M Norberg, D.O., Principal Investigator, National Cancer Institute (NCI)
Verification Date
December 15, 2020