Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies (NCT00923026) | Clinical Trial Compass
By InvitationNot Applicable
Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies
United States1,150 participantsStarted 2009-06-15
Plain-language summary
Background:
The NCI Surgery Branch has developed experimental therapies that involve taking white blood cells from participants' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient.
Objective:
This study will allow participants to be followed for up to 15 years following treatment on an NCI Surgery Branch Gene Therapy Trial as required by the FDA.
Eligibility:
Participants must have been enrolled on an NCI Surgery Branch Gene Therapy Protocol
Design
Participants will be followed with a physical examination and blood tests for up to 15 years as required by the FDA
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
For Cohort B: Individuals of child-bearing potential (IOCBP) who are pregnant or plan to become pregnant because of the potentially dangerous effects of the investigational treatments administered on NCI-SB treatment protocols.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is specifically for people who were previously enrolled in an NCI Surgery Branch study, can you confirm whether my prior participation qualifies me to be considered for this follow-up protocol?
2This study is focused on long-term follow-up rather than active treatment — what kinds of check-ins, tests, or monitoring would actually be involved, and how often would I need to come in or report information?
3Because this is listed as 'enrolling by invitation only,' does that mean the NCI team would need to reach out to me first, or is there a way for you to help initiate contact on my behalf?
4Given that my condition is one of those covered — such as melanoma or a neuroendocrine tumor — how does participating in this long-term follow-up compare to the monitoring I would already receive as part of my standard care?
5Are there any risks or burdens to participating in a follow-up study like this, even if it doesn't involve new treatments, that I should weigh before agreeing to take part?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.