750 Participants Needed

Gene Therapy Follow-Up for Cancer

Recruiting at 1 trial location
SA
JL
Overseen ByJennifer L Marte
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: National Cancer Institute (NCI)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial monitors the long-term health of individuals who previously received a vaccine known as poxviral vector gene transfer. These vaccines use a virus to deliver genetic material, aiding the body in fighting diseases like cancer. The trial does not involve new medications; it focuses on annual health check-ups to monitor for any delayed side effects. It is designed for those who received these vaccines through specific studies at the National Cancer Institute. Participants will undergo yearly health assessments for up to 15 years to ensure continued well-being. As an unphased trial, this study allows participants to contribute to valuable long-term health data without requiring new treatments.

Why are researchers excited about this trial?

Researchers are excited about poxviral vector gene transfer treatments because they offer a novel approach to delivering genetic material directly into cells to potentially correct genetic disorders at their source. Unlike traditional treatments that often manage symptoms, this technique uses a modified virus as a vehicle to introduce new or modified genes into the patient's cells. This method could provide a more targeted and potentially long-lasting solution, addressing the root cause of the condition rather than just alleviating its symptoms. Additionally, this approach may offer benefits in terms of safety and efficiency compared to other gene therapy methods, as poxviral vectors are designed to reduce immune responses and enhance gene delivery.

Who Is on the Research Team?

JL

Jennifer L Marte

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Not specified

Follow-up

Annual medical history and physical examinations for the first 5 years following the last vaccine

5 years
Annual in-person visits

Extended Follow-up

Annual telephone contact during the last 10 years

10 years
Annual telephone contact

Long-term Monitoring

Health status check including primary cancer status, secondary malignancies, neurologic disorders, autoimmune disorders, and hematologic disorders

15 years

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+