A Study to Identify Late-Occurring Complications in Childhood Cancer Survivors
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-002484
NCT ID: NCT00082745
Sponsor Protocol Number: ALTE03N1
About this study
The purpose of this trial is to identify cancer survivors 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, heart attack, 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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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;
- 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 buccal cell specimen) to the Clinical Pharmacokinetics Laboratory at St. Jude Children's Research Hospital 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 cancer at age 21 or younger, irrespective of current age.
- CONTROL: No prior history of allogeneic (non-autologous) hematopoietic cell transplant.
- CONTROL: No clinical evidence of any of the following key adverse events:
- Cardiac dysfunction (CD); 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 WBC is > 2,000;
- Myocardial infarction (MI);
- Ischemic stroke (IS);
- Avascular necrosis (AVN);
- Subsequent malignant neoplasm (SMN).
- CONTROL: Submission of a blood specimen (or in certain cases a buccal cell specimen) to the Clinical Pharmacokinetics Laboratory at St. Jude Children's Research Hospital as per the requirements.
- CONTROL: Written informed consent from the patient and/or the patient?s legally authorized guardian.
- CONTROL: 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Wendy Allen-Rhoades, M.D., Ph.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available