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Clinical Trial NCT07489378 for Very Rare Tumors, Very Rare Cancers, Other Solid Tumors, Solid Tumor, Pediatric Rare Tumors is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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National Cancer Institute (NCI)NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors 4,000 Pediatric Adolescent
Clinical Trial NCT07489378 is an observational study for Very Rare Tumors, Very Rare Cancers, Other Solid Tumors, Solid Tumor, Pediatric Rare Tumors and is currently not yet recruiting. Enrollment is planned to begin on 5 April 2026 and continue until the study accrues 4,000 participants. Led by National Cancer Institute (NCI), this study is expected to complete by 1 April 2037. The latest data from ClinicalTrials.gov was last updated on 31 March 2026.
Brief 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:...
Show MoreDetailed Description
Background:
- Rare cancers are defined by the NCI as fewer than 15 incident cases per 100,000 people per year. Overall, pediatric tumors account for less than 1% of all cancers diagnosed in the United States (US) per year.
- The European Cooperative Study Group for Pediatric Rare Tumors (EXPeRT) group has determined that the definition of very rare pediatric cancers is fewer than 2 cases per million per year and/or ...
Official Title
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Conditions
Very Rare TumorsVery Rare CancersOther Solid TumorsSolid TumorPediatric Rare TumorsOther Study IDs
- 10002496
- 002496-C
NCT ID Number
Start Date (Actual)
2026-04-05
Last Update Posted
2026-03-31
Completion Date (Estimated)
2037-04-01
Enrollment (Estimated)
4,000
Study Type
Observational
Status
Not yet recruiting
Keywords
Longitudinal Study
Registry
Patient Reported Outcomes
Family History
Molecular Characterization
Registry
Patient Reported Outcomes
Family History
Molecular Characterization
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
1/ Cohort 1 Participants with very rare tumors | Natural history study of individuals with very rare tumors We will collect information about the initial presentation and diagnosis of the disease, management, and tumor treatment history. Participants or parent/guardian will be asked to complete questionnaires and patient-reported outcome (PRO) instruments. Pathology materials (e.g., tissue samples, slides, or blocks) and saliva and/or buccal sample will be requested. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
To establish a longitudinal observational study and registry for very rare pediatric and AYA solid tumors | Percentage of participants from identified recruitment sources will be tabulated and described. An analysis of the ability to adequately obtain medical records at initial evaluation and follow-up to perform medical data extraction, which is critical to establishing a registry and longitudinal observational study will be assessed. | Through 5 years after enrollment |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
To evaluate the feasibility of PRO using validated reporting platforms suitable for pediatric and AYA populations | The percentage of participants who successfully complete longitudinal data collection will be described. | At time of enrollment/study entry, and 2 and 5 years after enrollment |
To conduct comprehensive clinical molecular characterization, utilizing CCDI MCI | The percentage of participants who successfully provide required sample(s) and where correlative analyses are able to be performed will be described. | At time of enrollment/study entry |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Minimum Age
1 Month
Eligible Sexes
All
- 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.
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.
National Cancer Institute (NCI)Study Central Contact
Contact: Mary F Wedekind Malone, D.O., (240) 858-3765, [email protected]
1 Study Locations in 1 Countries
Maryland
National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States
National Cancer Institute Referral Office, Contact, 888-624-1937, [email protected]