Long-Term Follow-Up of Recipient of Gene Transfer Research
The goal of this clinical research study is to collect information about the long-term safety of gene transfer therapy. This study is also designed to create a database of medical information about patients who have received gene transfer therapy, in order for researchers to track and review the long-term safety and an
| Condition(s) | Retroviridae Infections, Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | The goal of this clinical research study is to collect information about the long-term safety of gene transfer therapy. This study is also designed to create a database of medical information about patients who have received gene transfer therapy, in order for researchers to track and review the long-term safety and any effects (good or bad) of gene transfer therapy. |
| Who can participate | Inclusion Criteria: 1. Patient or patient's legal representative(s) provided written informed consent to participate in a gene transfer study at the University of Texas MD Anderson Cancer Center (MD Anderson). 2. Patient will receive vector or vector-treated cells at MD Anderson. 3. Patient or patient's legal representative(s) is/are able to provide written informed consent to participate in this long-term follow-up protocol for gene transfer participants for up to 15 years following administration of gene therapy product. 4. Agree to allow clinical samples to be collected and stored at MD Anderson and/or at a NIH designated facility such as the NGVB. Exclusion Criteria: 1\) Subject's gene transfer protocol is not approved at MD Anderson Cancer Center. |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | M.D. Anderson Cancer Center |
| Locations | Houston, Texas, United States |
| Start date | 2011-12-09 |
| NCT ID | NCT01492036 |
| Official listing | https://clinicaltrials.gov/study/NCT01492036 |