NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cance… (NCT07489378) | Clinical Trial Compass
RecruitingNot Applicable
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
United States4,000 participantsStarted 2026-08-18
Plain-language summary
Background:
All childhood cancers are rare, but some are called very rare. Very rare cancers are diagnosed in 2 or fewer out of 1 million people each year. Researchers want to gather data so they can learn more about these very rare cancers. They hope to use the data to develop future treatments.
Objective:
To gather data for a registry of very rare cancers found in children, teens, and young adults.
Eligibility:
People aged 1 month to 39 years newly diagnosed (within the past year) with a very rare cancer.
Design:
Participation will be by phone or email. No clinic visits are required.
Researchers will look at the participant s medical records. They will ask for samples of tumor tissue that were already removed. They will use the samples for genetic testing. The results of these tests will be sent to the participant s own doctors.
Some participants will be asked for saliva or cheek swab samples. They will receive a kit in the mail. They will spit into a tube or swab the inside of their cheek. They will mail the sample back to the lab.
Participants will fill out questionnaires once a year for 5 years. They will answer questions about:
Family history, such as other cancers in the family and their income, work, and education.
Demographics, such as their gender, nationality, ethnicity, education, and work history.
Symptoms and treatment for their cancer. This may include level of pain, and emotional and physical well-being.
Participants data will be added to a secure database for other researchers. Their data will be anonymous.
Who can participate
Age range
1 Month – 120 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:
* History of newly diagnosed (within 1 year of diagnosis) very rare solid tumor (defined as an estimated 2 incident cases per million per year).
* Age \>= 1 month and \<= 39 years at the time of diagnosis.
* Participants must have established care with a local treating physician.
* Ability of the participant, parent/guardian, or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
* Diagnosis of any of the following at any time:
* Ewing Sarcoma
* Osteosarcoma
* Rhabdomyosarcoma
* Diffuse midline glioma (H3K27 altered)
* Atypical teratoid rhabdoid tumor
* Pleuropulmonary blastoma
* Common adult cancers that occur in pediatric/AYA populations (i.e., colorectal cancer, breast cancer)
* The participant is unlikely to comply with the terms of the protocol.
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 is an observational registry rather than a treatment trial, can you explain what joining would actually involve for us — like how often data would be collected and whether it would require extra visits or procedures?
2This registry is specifically for very rare pediatric and AYA solid tumors run through the NCI's Childhood Cancer Data Initiative — does my child's specific diagnosis qualify as 'very rare' in the way this study defines it, and is our hospital a participating site?
3Because this is a data registry and not a Phase 1 or 2 treatment study, it won't directly change how my child is treated — so how might participating still benefit us, and could the information collected ever connect us to future treatment trials?
4Would enrolling in this registry affect our ability to also pursue an active treatment trial at the same time, or can both happen in parallel?
5Since the goal is long-term longitudinal follow-up, how long would we be expected to stay enrolled, and what does the commitment look like if our child's condition changes or we want to withdraw?
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
To establish a longitudinal observational study and registry for very rare pediatric and AYA solid tumors