Long-Term Follow-Up of Recipient of Gene Transfer Research
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Retroviridae Infections Cancer |
Other: Blood Tests Behavioral: Questionnaires |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Long-Term Follow-Up Study of Recipients of Gene Transfer Research Protocols |
- Document Long-Term Safety of Gene-Transfer Research [ Time Frame: 15 years ] [ Designated as safety issue: No ]First 5 years following infusion of vector or vector-treated cells: Participants evaluated on annual basis. Years 6 to 15 following infusion of vector or vector-treated cells: Participants mailed questionnaires. Participants in retroviral studies: Up to 60 mL (max 1 mL/kg) blood will be obtained to check for replication-competent retrovirus (RCR) every 3 months during the first year, and then blood archived annually thereafter. Replication competent vector testing performed when there is a clinical indication or when requested by the FDA.
Biospecimen Retention: Samples With DNA
Study visits once a year during Years 1-5. Blood (about 2-4 tablespoons each time) will be drawn for routine tests. If retroviral gene transfer therapy received, blood (up to 4 tablespoons each time) will be drawn every 3 months for the first year after gene transfer therapy and once a year after that. (If joining study more than a year after gene transfer therapy, RCR test will be performed once a year for all 15 years of the study.)
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2011 |
| Estimated Primary Completion Date: | December 2026 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Gene Transfer Therapy
Study participants will have received the gene therapy product at M.D. Anderson Cancer Center prior to participating in this protocol.
|
Other: Blood Tests
If participant received retroviral gene therapy, blood test performed to check for a type of infection called the replication-competent retrovirus (RCR). For this test, blood (up to 4 tablespoons each time) will be drawn every 3 months for the first year after gene transfer therapy and once a year after that. (If joining this study more than a year after gene transfer therapy, however, this RCR test will be performed once a year for all 15 years of the study.)
Other Name: Blood draw
Behavioral: Questionnaires
Once a year during Years 1-5, questionnaire completions that asks about medical history (general health, the status of any medical conditions, and any illnesses or hospitalizations that may have occurred). It should take about 15-30 minutes to complete. Once a year during Years 6-15, completion of mailed questionnaire. Participant will be asked about medical history (including if participant has had any children since the infusion) and whether there have been any changes in contact information. The questionnaires should take about 15-30 minutes each time. Other Name: Surveys
|
Show Detailed Description Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Gene transfer therapy in an M. D. Anderson Cancer Center research study in Houston, Texas
Inclusion Criteria:
- Signed assent/consent to participate in a gene transfer study at the University of Texas M.D. Anderson Cancer Center (M.D. Anderson) and participated in a gene transfer study.
- Received vector or vector-treated cells at M.D. Anderson.
- Agree to sign an informed consent/assent to participate in the long-term follow up protocol for gene transfer participants for up to 15 years following administration of gene therapy product.
- Agree to allow clinical samples to be collected and stored at M.D. Anderson and/or at a NIH designated facility such as the NGVB.
Exclusion Criteria:
- Participant of a gene transfer protocol for which Dr. Laurence Cooper is not the PI or Co-PI of the protocol.
- Subject's gene transfer protocol is not approved at M.D. Anderson Cancer Center. To participate in this protocol, the gene therapy product must have been administered at M.D. Anderson.
Contacts and Locations| Contact: Laurence JN Cooper, MD,PHD | 713-792-6620 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Laurence JN Cooper, MD, PHD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01492036 History of Changes |
| Other Study ID Numbers: | 2006-0676, R01CA124782, R01CA141303 |
| Study First Received: | December 12, 2011 |
| Last Updated: | April 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Replication-Competent Retrovirus RCR Gene transfer therapy Registry Medical information database Vector or vector-treated cells Blood draw |
Computed tomography CT Questionnaires Surveys Gene Transfer Research National Gene Vector Biorepository and Coordinating Center NGVB |
Additional relevant MeSH terms:
|
Retroviridae Infections RNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on May 23, 2013