Solid Tumors Clinical Trial
Official title:
Follow-Up Evaluation for Gene-Therapy Related Delayed Adverse Events After Participation in Pediatric Oncology Branch Clinical Trials
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 involves changing the genes inside the body s cells to stop disease. It is very closely regulated. People who have had this therapy may have problems months or even years later. Researchers do not know the long-term side effects, so they want to study people who have had the therapy. They want the study to continue over the next 15 years. Objective: - To study over time the negative side effects from genetically engineered cellular therapy. This will be studied in people who have been in Pediatric Oncology Branch (POB) gene therapy trials. Eligibility: - People who are currently or were previously in a research study with gene therapy in the National Cancer Institute POB. Design: - Participants blood will be tested right before they get the genetically changed cells. They will get the cells as part of another study. - For the next year, they will come back to the clinic or see their doctor at home at least every 3 months. They will answer questions about their health and blood will be drawn. - For the next 5 years, they will go to the clinic or see their own doctor once a year. They will have physical exam and blood will be drawn. - For 10 years after that, they will be asked every year for health information. - Participants will keep their contact information up to date with researchers. They may be phoned for more health information. - If the participant was under 18 years old when given the gene therapy and turns 18 during this follow-up, they will be asked to sign a new consent form when they turn 18.
Status | Enrolling by invitation |
Enrollment | 500 |
Est. completion date | August 1, 2050 |
Est. primary completion date | April 1, 2035 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 99 Years |
Eligibility | - INCLUSION CRITERIA: - Subjects must be identified eligible for, participating in, or have participated in a POB genetically engineered cellular therapy clinical trial and have received/or be scheduled to receive a genetically engineered cellular therapy. - All monitoring and testing described in this protocol will pertain ONLY to genetically engineered cellular therapy received at the National Institutes of Health (NIH). RCR/RCL monitoring and persistence will NOT be followed for cells administered at another institution. |
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 | Conduct long term safety evaluations after gene therapy | PCR results (for RCR/RCL, gene transduced cells) | Every 3 months X 1 year then annually X 15 years |
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