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NCT Number: NCT00451022

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

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.

Recruiting

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Key information

Conditions

Prostate Cancer Breast Cancer Breast Diseases Breast Neoplasms Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Liver Cancer Liver Diseases Liver Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location status: Recruiting

Location contact

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

CONTACT

[email protected]

800-411-1222 ext. TTY dial 711

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • INCLUSION CRITERIA:
  • Subjects who received poxviral vectors (vaccinia and/or fowlpox) or other vaccines utilizing gene transfer or any other immunotherapeutic agent through GMB, UOB and LTIB affiliated trials at the National Cancer Institute, as well as subjects at extramural sites receiving these agents as part of a multi-site trial. Available stored specimens obtained from NCI participants in GMB, UOB, and LTIB affiliated protocols may be transferred to this protocol for storage and eventual future research use.
  • Subjects must be >= 18 years of age.

Exclusion criteria

Participants unwilling to participate.

(Please note, participants may participate in this protocol and, at the same time, participate in an active treatment or continuing care study.)

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer L Marte

CONTACT

[email protected]

(301) 496-7214

Sheri A McMahon, R.N.

CONTACT

[email protected]

(240) 760-7968

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

Follow-Up Study of Subjects Previously Enrolled in Immunotherapy Studies Utilizing Gene Transfer or Other Immunotherapeutic Agents

Important dates

Study start
2004
First posted
Mar 22, 2007
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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