Long-term follow-up for patients previously treated with poxviral vector gene therapy
Follow-Up Study of Subjects Previously Enrolled in Immunotherapy Studies Utilizing Gene Transfer or Other Immunotherapeutic Agents
National Institutes of Health Clinical Center (CC) · NCT00451022
This study is checking on the long-term health of cancer patients who received poxviral vector gene therapy to see how they are doing years later.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 750 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00451022 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who previously received poxviral vectors or other immunotherapeutic agents in affiliated trials.
Not a fit: Patients who did not participate in prior poxviral vector studies or are unwilling to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and health outcomes of patients who received gene therapy.
How similar studies have performed: Other studies have shown the importance of long-term follow-up in gene therapy, indicating that this approach is supported by previous findings.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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 this trial is running
Bethesda, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Liver Cancer, Breast Cancer, Colon Cancer, Lung Cancer, Gene Therapy, Long Term Survivor, Research Specimen