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

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT00451022
Collaborator
(none)
750
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    750 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Follow-Up Study of Subjects Previously Enrolled in Immunotherapy Studies Utilizing Gene Transfer or Other Immunotherapeutic Agents
    Actual Study Start Date :
    Sep 13, 2004

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort 1

    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.

    Outcome Measures

    Primary Outcome Measures

    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. [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. [on-going]

      Continued analysis on stored specimen samples until the samples are completely used.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    • 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.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institutes of Health Clinical Center Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Jennifer L Marte, National Cancer Institute (NCI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00451022
    Other Study ID Numbers:
    • 040274
    • 04-C-0274
    • NCT01444963
    First Posted:
    Mar 22, 2007
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 16, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Cancer Institute (NCI)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 22, 2022