Follow-up of Breast Cancer and Multiple Myeloma Patients Previously Enrolled in NIH Gene Therapy Studies
|First Submitted Date||January 25, 2007|
|First Posted Date||January 29, 2007|
|Last Update Posted Date||October 6, 2017|
|Start Date||March 6, 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00427726 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Follow-up of Breast Cancer and Multiple Myeloma Patients Previously Enrolled in NIH Gene Therapy Studies|
|Official Title||Follow-Up Study of Breast Cancer and Multiple Myeloma Subjects Previously Enrolled in Retroviral Gene Transfer Studies|
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.
|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 Design||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Estimated Completion Date||May 20, 2014|
|Primary Completion Date||Not Provided|
Subjects who received gene transfer products on the following protocols: MB 361, 96-C-0007, T-95-0096; MB 294, 92-C-0161, T-92-0018; MB 310, 93-C 0208, T-92-0192; or 92-H-0057, T-92-0139.
Patients unwilling to participate.
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||030124
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||National Cancer Institute (NCI)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 20, 2014|