Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00427726
Status:
COMPLETED
Last Update Posted:
2019-12-12
First Post:
2007-01-25
Brief Title:
Follow-up of Breast Cancer and Multiple Myeloma Patients Previously Enrolled in NIH Gene Therapy Studies
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Follow-Up Study of Breast Cancer and Multiple Myeloma Subjects Previously Enrolled in Retroviral Gene Transfer Studies
Status:
COMPLETED
Status Verified Date:
2014-05-20
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will provide follow-up evaluations of breast cancer or multiple myeloma patients who received gene therapy gene transfer as part of their participation in an NIH protocol Gene therapy is a new technology which may involve a permanent change in the patient s genetic code Therefore although the risk of long-term harmful effects of this therapy is very small the Food and Drug Administration requires prolonged monitoring of patients health status
Patients previously enrolled in NIH protocols 96-C-0007 93-C-0208 92-C-0161 or 92-H-0057 will be followed under the current protocol No further gene therapy will be provided in this study
Patients health status will be evaluated for an indefinite period of time or as long as they are willing to be monitored They will provide a blood sample once a year and will be interviewed about their health status twice a year for the first 5 years after gene therapy and once a year thereafter These procedures are done to look for the development of any diseases such as cancer neurological disorders autoimmune or blood disorders that may be related to side effects of the gene transfer
Patients previously enrolled in NIH protocols 96-C-0007 93-C-0208 92-C-0161 or 92-H-0057 will be followed under the current protocol No further gene therapy will be provided in this study
Patients health status will be evaluated for an indefinite period of time or as long as they are willing to be monitored They will provide a blood sample once a year and will be interviewed about their health status twice a year for the first 5 years after gene therapy and once a year thereafter These procedures are done to look for the development of any diseases such as cancer neurological disorders autoimmune or blood disorders that may be related to side effects of the gene transfer
Detailed Description:
This Protocol aims to provide long-term follow-up of breast cancer and multiple myeloma subjects previously receiving autologous primitive marrow and blood hematopoietic cells exposed to gene transfer retroviral vectors on the following protocols MB 294 92-C-0161 T-92-0018 MB 310 93-C-0208 T-92-0192 MB 361 96-C-0007 T-95-0096 or 92-H-0057 T-92-0139 at the National Cancer Institute and the National Heart Lung and Blood Institute Subjects will undergo an annual health history and annual complete blood counts will be performed Blood samples will also be collected annually either locally or off-site by the subjects personal physicians for testing for presence of the gene transfer vector and vector integration sites
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-C-0124 | None | None | None |