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Follow-Up Study of Subjects Previously Enrolled in Poxviral Vector Gene Transfer Studies

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 330 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Eligibility criteria expanded, about 3 words
  2. Minor 49 versions Re-verified since Jan 26, 2024, no change to tracked fieldsv281-v329
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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and 2 more diseases
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.
Trial Details
NCT Number NCT00451022
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)
Prostate Cancer, Liver Cancer, Breast Cancer, Colon Cancer, Lung Cancer
Related terms Breast Neoplasms, Colonic Neoplasms, Liver Neoplasms, Lung Neoplasms, Prostatic Neoplasms
Enrollment 750 participants
Start Date
Updated on ClinicalTrials.gov