Long-term follow-up for patients previously treated with poxviral vector gene therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on the long-term follow-up of patients who were previously enrolled in studies involving poxviral vector gene therapy for various cancers. Participants will undergo annual health assessments for up to 15 years to monitor their health status and any potential long-term effects of the gene therapy. The study aims to ensure compliance with new reporting requirements for adverse events associated with gene therapy. It does not involve any new treatments or interventions but emphasizes the importance of ongoing health monitoring.

Why it matters

Who can join: the full rules

* 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.)

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Jennifer L Marte — National Cancer Institute (NCI)
• Study coordinator: Sheri A McMahon, R.N.
• Email: sheri.mcmahon@nih.gov
• Phone: (240) 760-7968

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.