Gene Therapy Follow up Protocol for Subjects Previously Enrolled in NCI Center for Immuno-Oncology Studies
Launched by NATIONAL CANCER INSTITUTE (NCI) · Feb 11, 2020
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
Background:
The NCI CIO 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 CIO treatment proto...
Gender
ALL
Eligibility criteria
- * INCLUSION CRITERIA:
- • Subjects who have enrolled on an applicable NCI CIO gene therapy treatment protocol. Age \>= 18 years. Note: Children are generally excluded from CIO gene therapy studies and inclusion on this follow-up study will be limited to 18 years and older.
- EXCLUSION CRITERIA:
- • -Children
About National Cancer Institute (Nci)
The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bethesda, Maryland, United States
Patients applied
Trial Officials
Scott M Norberg, D.O.
Principal Investigator
National Cancer Institute (NCI)
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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