NCT04266093

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

ENROLLING BY INVITATION Last updated 14 April 2026

What this trial tests

trial testing GeneTherapy in Cervical Intraepithelial Neoplasia in 1,000 participants. Enrolling by invitation.

Timeline

8 May 2020

Primary endpoint
1 October 2035

1 October 2050

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Status	ENROLLING BY INVITATION
Study type	OBSERVATIONAL
Enrollment	1,000
Start date	8 May 2020
Primary completion	1 October 2035
Estimated completion	1 October 2050
Sites	1 location across United States

Drugs / interventions tested

• GeneTherapy — full drug profile →

Conditions studied

• Cervical Intraepithelial Neoplasia — all drugs for Cervical Intraepithelial Neoplasia →
• Cervical Neoplasms — all drugs for Cervical Neoplasms →
• Oropharyngeal Neoplasms — all drugs for Oropharyngeal Neoplasms →
• Squamous Intraepithelial Lesions of the Cervix — all drugs for Squamous Intraepithelial Lesions of the Cervix →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 120, any sex, with Cervical Intraepithelial Neoplasia or Cervical Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

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Publications & conference data

No peer-reviewed publications indexed yet for this trial.