Cervical Intraepithelial Neoplasia Clinical Trial
Official title:
Gene Therapy Follow up Protocol for Subjects Previously Enrolled in NCI Center for Immuno-Oncology Studies
Verified date | June 3, 2024 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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. ...
Status | Enrolling by invitation |
Enrollment | 1000 |
Est. completion date | October 1, 2050 |
Est. primary completion date | October 1, 2035 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility | - INCLUSION CRITERIA: - Subjects who have received gene therapy on an applicable NCI CIO 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. EXCLUSION CRITERIA: -Children |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 15 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04537156 -
Efficacy, Immunogenicity and Safty Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)
|
Phase 3 | |
Completed |
NCT02907333 -
Testing Use of Condoms on Regression of Cervical Intraepithelial Neoplasia
|
N/A | |
Recruiting |
NCT02576262 -
HPV Integration Testing for Human Papillomavirus-Positive Women
|
N/A | |
Completed |
NCT01029990 -
Randomized Controlled Trial to Study Interventions to Increase Participation in Cervical Cancer Screening Program
|
Phase 0 | |
Recruiting |
NCT05078528 -
Low-cost Imaging Technology for Global Prevention of Cervical Cancer
|
N/A | |
Recruiting |
NCT05502367 -
A Study of ABI-2280 Vaginal Tablet in Participants With Cervical Intraepithelial Neoplasia
|
Phase 1/Phase 2 | |
Completed |
NCT02494310 -
HRME: Screening for Cervical Cancer and Its Precursors in Low‐Resource Settings
|
N/A | |
Active, not recruiting |
NCT03429582 -
Comparison of Cervical CIN II/III Treatment Outcomes With Thermal Ablation Device
|
N/A | |
Active, not recruiting |
NCT02140021 -
Biospecimen Collection and Testing for the Prevalence of Anal Dysplasia and Anal Cancer in Patients With Cervical, Vaginal and Vulvar Dysplasia and Cancer
|
N/A | |
Not yet recruiting |
NCT05510830 -
Diagnostic Cervical Conization for Persistent Infection or Integration of HPV
|
N/A | |
Completed |
NCT02237326 -
Visual Inspection With Acetic Acid Compared to Lugol's Iodine in HIV-infected Women
|
N/A | |
Completed |
NCT00316706 -
Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine
|
Phase 3 | |
Withdrawn |
NCT03143491 -
Study of SOR007 Ointment for Cervical Intraepithelial Neoplasia (CIN)
|
Phase 2 | |
Completed |
NCT03293628 -
Comparing Two Techniques of Haemostasis After Cervical Conization
|
Phase 2 | |
Recruiting |
NCT05266898 -
Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV
|
Phase 4 | |
Completed |
NCT02481414 -
A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions
|
Phase 2 | |
Completed |
NCT02247999 -
Improving Cervical Cancer Screening Among HIV-Infected Women in India
|
||
Recruiting |
NCT04650711 -
Immunohistochemical Staining of p16 for the Screening of Cervical Cancer
|
Phase 2 | |
Recruiting |
NCT04646954 -
DNA Methylation Testing for the Screening of Uterine Cervical Lesion
|
Phase 3 | |
Completed |
NCT01544478 -
V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)
|
Phase 4 |