Follow-Up Study of Subjects Previously Enrolled in Poxviral Vector Gene Transfer Studies
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|ClinicalTrials.gov Identifier: NCT00451022|
Recruitment Status : Recruiting
First Posted : March 22, 2007
Last Update Posted : November 13, 2023
This study aims to provide long-term follow-up care of patients previously enrolled in a vaccine study that involved poxviral vectors. Vectors are sequences of genetic material that can be used to introduce specific genes into genetic makeup. The study does not involve the use of any drug or biologic agent. Participants will undergo an annual health history. Because certain viruses enter into cells and create proteins from the viral genes, the type of vaccine treatment used is referred to gene therapy. The genes expressed by poxviral vectors do not become part of the genetic material left behind. Because gene therapy is a somewhat new technology, a prolonged monitoring of patients' health status is necessary, according to new specific reporting requirements for harmful events in patients who undergo such gene therapy studies. The risk of any long-term negative effects from the gene therapy that patients had received is quite small. Still, it is important that there be updates at least annually. This annual monitoring of health status will extend for 15 years, according to guidelines from the Food and Drug Administration, or for as long as patients are willing to participate.
Patients who received poxviral vectors (vaccinia or fowlpox, or both) at the National Cancer Institute, through a trial affiliated with the Laboratory of Tumor Immunology and Biology, may be eligible for this study.
Participants will be involved in the following forms of data collection:
- Annual medical history and physical examinations for the first 5 years following the last vaccine.
- Annual telephone contact during the last 10 years.
- Health status check, including primary cancer status, secondary malignancies, neurologic disorders, autoimmune disorders, and hematologic disorders.
- Blood tests for the presence of HIV antibodies.
- Reporting of medical problems, including information on unexpected hospitalizations and medications.
If a participant has died, the study will document the cause of death and autopsy information if available.
|Condition or disease|
|Prostate Cancer Liver Cancer Breast Cancer Colon Cancer Lung Cancer|
|Study Type :||Observational|
|Estimated Enrollment :||750 participants|
|Official Title:||Follow-Up Study of Subjects Previously Enrolled in Immunotherapy Studies Utilizing Gene Transfer or Other Immunotherapeutic Agents|
|Actual Study Start Date :||September 13, 2004|
Subjects previously participating in gene transfer or other immunotherapy studies at the NCI or extramural sites receiving therapeutic agents as part of a multi-site trial.
- To provide a mechanism for adequate follow-up of subjects previously participating in gene transfer or other immunotherapy studies at the National Cancer Institute as required by the U.S. Food and Drug Administration. [ Time Frame: on-going ]Annual history and physical examinations for the first 5 years of follow-up and an annual telephone contact during the next 10 years.
- To facilitate the continuous usage of stored research specimens collected from subjects under completed and ongoing protocols. [ Time Frame: on-going ]Continued analysis on stored specimen samples until the samples are completely used.
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): NCT00451022
|Contact: Sheri A McMahon, R.N.||(240) firstname.lastname@example.org|
|Contact: Jennifer L Marte||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY dial 711 firstname.lastname@example.org|
|Principal Investigator:||Jennifer L Marte||National Cancer Institute (NCI)|