An observational study in Cervical Intraepithelial Neoplasia, Cervical Neoplasms and Oropharyngeal Neoplasms, sponsored by National Cancer Institute (NCI). Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by National Cancer Institute (NCI) · Observational
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.
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 protocol for gene therapy.
Design:
Patients will undergo physical exams, laboratory evaluations and/or phone follow up as required by the treatment protocol and/or as clinically indicated.
5 studies on the registry are indexed under Squamous Intraepithelial Lesions of the Cervix; 4 are open to participants now.
Browse Squamous Intraepithelial Lesions of the Cervix studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 412 completed or terminated interventional studies of FDA-regulated products, 374 (91%) have results posted.
Compared within Squamous Intraepithelial Lesions of the Cervix, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Uterine Cervical Dysplasia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
EXCLUSION CRITERIA:
-Children
Subjects who have enrolled on an applicable NCI CIO gene therapy treatment protocol.
Drug: GeneTherapy
Observation/ Gene Therapy Long-term Follow-up. Subjects who have enrolled on an applicable NCI CIO gene therapy treatment protocol.
To provide long term follow up of patients previously enrolled on treatment protocols in the NCI CIO.
List of long time adverse event frequency after Gene therapy drug
Time frame: 15 years
Started May 2020 (actual). Primary completion is estimated for Oct 2035, 184 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Squamous Intraepithelial Lesions of the Cervix →
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