Gene Therapy Follow up Protocol for Subjects Previously Enrolled in NCI Center for Immuno-Oncology Studies

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04266093
Status
Enrolling By Invitation

Conditions

  • Cervical Intraepithelial Neoplasia
  • Cervical Neoplasms
  • Hematologic Malignacies
  • Oropharyngeal Neoplasms
  • Squamous Intraepithelial Lesions of the Cervix

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • GeneTherapy — DRUG
    Observation/ Gene Therapy Long-term Follow-up. Subjects who have enrolled on an applicable NCI CIO gene therapy treatment protocol.

Study Details

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 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. ...

Key Dates

Start date
May 8, 2020
Status verified
Dec 2025
Primary completion
Oct 1, 2035
Completion
Oct 1, 2050

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Cohort 1
    Subjects who have enrolled on an applicable NCI CIO gene therapy treatment protocol.

Primary Outcome Measure

To provide long term follow up of patients previously enrolled on treatment protocols in the NCI CIO. [ Time Frame: 15 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

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National Institutes of Health Clinical Center· Bethesda, MD

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