Long-Term Follow-Up of Recipient of Gene Transfer Research
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|ClinicalTrials.gov Identifier: NCT01492036|
Recruitment Status : Recruiting
First Posted : December 14, 2011
Last Update Posted : February 27, 2023
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|Condition or disease||Intervention/treatment|
|Retroviridae Infections Cancer||Other: Blood Tests Behavioral: Questionnaires|
|Study Type :||Observational|
|Estimated Enrollment :||130 participants|
|Official Title:||Long-Term Follow-Up Study of Recipients of Gene Transfer Research Protocols|
|Actual Study Start Date :||December 9, 2011|
|Estimated Primary Completion Date :||December 31, 2026|
|Estimated Study Completion Date :||December 31, 2027|
Gene Transfer Therapy
Study participants receiving gene therapy product at MD Anderson Cancer Center
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). Blood (up to 4 tablespoons each time) drawn every 3 months for first year after gene transfer therapy and once a year after that.
Other Name: Blood draw
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
- Document Long-Term Safety of Gene-Transfer Research [ Time Frame: 15 years ]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
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- 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).
- Patient will receive vector or vector-treated cells at MD Anderson.
- 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.
- Agree to allow clinical samples to be collected and stored at MD Anderson and/or at a NIH designated facility such as the NGVB.
1) Subject's gene transfer protocol is not approved at MD Anderson Cancer Center.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492036
|Contact: Partow Kebriaei, MDemail@example.com|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Partow Kebriaei, MD||M.D. Anderson Cancer Center|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||M.D. Anderson Cancer Center|
|Other Study ID Numbers:||
R01CA124782 ( U.S. NIH Grant/Contract )
R01CA141303 ( U.S. NIH Grant/Contract )
|First Posted:||December 14, 2011 Key Record Dates|
|Last Update Posted:||February 27, 2023|
|Last Verified:||February 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Gene transfer therapy
Medical information database
Vector or vector-treated cells
Gene Transfer Research
National Gene Vector Biorepository and Coordinating Center
RNA Virus Infections