Long-Term Follow-Up of Recipient of Gene Transfer Research
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01492036|
Recruitment Status : Recruiting
First Posted : December 14, 2011
Last Update Posted : May 21, 2019
|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 2011|
|Estimated Primary Completion Date :||December 2026|
|Estimated Study Completion Date :||December 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
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, MDfirstname.lastname@example.org|
|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|