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

NCT04266093 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-05-22

No results posted yet for this study

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 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.

...

Conditions

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

Interventions

DRUG

GeneTherapy

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Scott M Norberg, D.O. · National Cancer Institute (NCI)

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-08
Primary Completion
2035-10-01
Completion
2050-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04266093 on ClinicalTrials.gov