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Follow-Up Study for Poxviral Vector Gene Transfer Studies

This study is for people who previously participated in gene transfer or immunotherapy studies at the National Cancer Institute, or at other sites as part of a multi-site trial. It aims to provide long-term follow-up care for these participants, especially those who received poxviral vectors (a type of gene therapy where viruses are used to deliver genetic material into cells) or other immunotherapy agents. The study does not involve new treatments or drugs. Instead, it focuses on understanding the long-term effects of these past treatments and continuing to use research samples collected from you. This helps researchers learn more about how these treatments work (immunotherapy) and meet requirements from the U.S. Food and Drug Administration. You can join if you are 18 or older and were part of one of these previous studies.

Study design
This is an observational study with a planned enrollment of 750 participants. It is not specified if it is randomized or blinded.
What's involved
You will undergo an annual health history for up to 15 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 15 years, with ongoing primary endpoints.

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NCT00451022

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

Recruiting
Not specifiedAges 18+Observational
National Cancer Institute (NCI)
~750 participants
Updated 2026-06-05 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over on-going
+1 more outcome measured

Conditions

Prostate Cancer
Liver Cancer
Breast Cancer
Colon Cancer
Lung Cancer

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Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Jennifer L Marte · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Sheri A McMahon, R.N.
[email protected]
(240) 760-7968
Email the study team

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Eligibility criteria

Inclusion

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.

What this trial measures

  • 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.