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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Therapy Follow up Protocol for Subjects Previously Enrolled in NCI Center for Immuno-Oncology Studies
- ClinicalTrials.gov ID
- NCT04266093
- Acronym / sponsor ID
- 200051
- Conditions
- Cervical Intraepithelial Neoplasia, Cervical Neoplasms, Oropharyngeal Neoplasms, Squamous Intraepithelial Lesions of the Cervix, Hematologic Malignacies
- Keywords
- Gene Transfer, Recombinant DNA Product, Gamma-Retroviral Vectors, Laboratory Evaluation, Natural History
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 8 May 2020 (actual)
- Primary completion
- 1 Oct 2035 (estimated)
- Study completion
- 1 Oct 2050 (estimated)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: GeneTherapySubjects who have enrolled on an applicable NCI CIO gene therapy treatment protocol. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- -Children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GeneTherapyObservation/ Gene Therapy Long-term Follow-up. Subjects who have enrolled on an applicable NCI CIO gene therapy treatment protocol. | Drug | Cohort 1 |
Primary outcome
To provide long term follow up of patients previously enrolled on treatment protocols in the NCI CIO.
Time frame: 15 years
List of long time adverse event frequency after Gene therapy drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Scott M Norberg, D.O. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Intraepithelial Neoplasia and Cervical Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To provide long term follow up of patients previously enrolled on treatment protocols in the NCI CIO. (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.