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

Recruiting

• Conditions: Colon Cancer; Prostate Cancer; Liver Cancer; Lung Cancer; Breast Cancer

• Registration Number: NCT00451022
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

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.

Detailed Description

This protocol aims to provide long-term follow-up and continued use of research specimens of participants previously enrolled on gene transfer or other immunotherapy studies at the National Cancer Institute as well as follow-up of subjects at extramural sites receiving these agents as part of a multi-site trial. Subjects will undergo an annual health history for up to 15 years.

Study Timeline

• Study Start: 2004-09-13
• Study First Submitted: 2007-03-20
• Study First Submitted QC: 2007-03-20
• Study First Posted: 2007-03-22
• Status Verified: 2025-03-28
• Last Update Submitted: 2025-05-24
• Last Update Posted: 2025-05-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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.	on-going	Continued analysis on stored specimen samples until the samples are completely used.

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States