Follow-up of Breast Cancer and Multiple Myeloma Patients Previously Enrolled in NIH Gene Therapy Studies
|First Received Date ICMJE||January 25, 2007|
|Last Updated Date||November 27, 2013|
|Start Date ICMJE||March 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00427726 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Follow-up of Breast Cancer and Multiple Myeloma Patients Previously Enrolled in NIH Gene Therapy Studies|
|Official Title ICMJE||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.
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 Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Gene Transfer|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00427726|
|Other Study ID Numbers ICMJE||030124, 03-C-0124|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP