Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors (NCT00082745) | Clinical Trial Compass
CompletedNot Applicable
Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors
United States, Australia, Canada3,885 participantsStarted 2004-03-25
Plain-language summary
This clinical trial studies cancer survivors to identify those who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer. A patient's genes may affect the risk of developing complications, such as congestive heart failure, avascular necrosis, stroke, and second cancer, years after undergoing cancer treatment. Genetic studies may help doctors identify survivors of childhood cancer who are more likely to develop late complications.
Who can participate
Age range
99 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.
Inclusion Criteria:
* ELIGIBILITY CRITERIA - CASES
* Diagnosis of primary cancer at age 21 or younger, irrespective of current age
* No prior history of allogeneic (non-autologous) hematopoietic cell transplant
* Development of one of the following key adverse events at any time following initiation of cancer therapy:
* Cardiac dysfunction; please note: case enrollment has been closed due to achievement of target accrual
* Ischemic stroke (IS)
* Subsequent malignant neoplasm (SMN)
* Avascular necrosis (AVN); please note: case enrollment has been closed due to achievement of target accrual
* Submission of a blood specimen (or in certain cases a saliva specimen) to the Coordinating Center at the University of Alabama at Birmingham as per the requirements; please note: if a patient is currently receiving active cancer treatment, it is preferable to obtain the blood sample at a time when the patient's white blood cell (WBC) is \> 2,000
* Written informed consent from the patient and/or the patient's legally authorized guardian
* In active follow up by a COG institution; active follow up will be defined as date of last visit or contact by a COG institution within the past 24 months; any type of contact, including contact specifically for participation in ALTE03N1, qualifies as active follow-up; please note: treatment on a COG (or legacy group) therapeutic protocol for the primary cancer is NOT required
* ELIGIBILITY CRITERIA - CONTROLS
* CONTROL: Diagnosis of primary can…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Rate of adverse events (cardiac dysfunction, AVN, ischemic stroke, and SMN using a matched case-control)
Timeframe: Up to 1 year
2
Frequency of mutations or polymorphisms in specific candidate genes in cases and controls