This study is currently recruiting participants.
National Cancer Institute (NCI)
Type: Enrolling by Invitation Gender: Male & Female Min Age: 18 Max Age: NA
Referral Letter Required
Gene Transfer; Recombinant DNA Product; Gamma-Retroviral Vectors; Laboratory Evaluation; Natural History
Cervical Intraepithelial Neoplasia; Cervical Neoplasms; Oropharyngeal Neoplasms; Squamous Intraepithelial Lesions of the Cervix; Hematologic Malignacies
E7 transducted PBL
National Cancer Institute
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.
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.
People aged 18 and older who have had gene therapy in a National Cancer Institute study
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.
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INCLUSION CRITERIA: -Subjects who have received gene therapy on an applicable NCI GMB protocol. Age greater than or equal to 18 years. Note: Children are generally excluded from GMB gene therapy studies and inclusion on this follow-up study will be limited to 18 years and older. EXCLUSION CRITERIA: -Children
-Subjects who have received gene therapy on an applicable NCI GMB protocol. Age greater than or equal to 18 years. Note: Children are generally excluded from GMB gene therapy studies and inclusion on this follow-up study will be limited to 18 years and older.
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