Cervical Intraepithelial NeoplasiaNCT04266093
Gene Therapy Follow up Protocol for Subjects Previously Enrolled in NCI Center for Immuno-Oncology Studies
An observational study of Cervical Intraepithelial Neoplasia and Cervical Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Cervical Intraepithelial Neoplasia, Cervical Neoplasms, Oropharyngeal Neoplasms
- What is being tested?
- GeneTherapy
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2020to 1 Oct 2050
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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.
Who cannot join
- -Children
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Cervical Intraepithelial Neoplasia, Cervical Neoplasms, Oropharyngeal Neoplasms, Squamous Intraepithelial Lesions of the Cervix, Hematologic Malignacies
- Being tested
- GeneTherapy
- Keywords
- Gene Transfer, Recombinant DNA Product, Gamma-Retroviral Vectors, Laboratory Evaluation, Natural History
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms, Oropharyngeal Neoplasms, Squamous Intraepithelial Lesions of the Cervix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GeneTherapyDrug
Observation/ Gene Therapy Long-term Follow-up. Subjects who have enrolled on an applicable NCI CIO gene therapy treatment protocol.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Subjects who have enrolled on an applicable NCI CIO gene therapy treatment protocol. Receives: Drug: GeneTherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start8 May 2020
- Primary completion1 Oct 2035 (estimated)
- Study completion1 Oct 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Scott M Norberg, D.O., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266093
- Sponsor's protocol ID
- 200051
- Other IDs
- 20-C-0051
- Status last verified
- 21 Aug 2026
- First submitted
- 11 Feb 2020
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No