NCI CCDI registry for very rare pediatric and young adult solid tumors
Official title: NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Run by National Institutes of Health Clinical Center (CC) · NCT07489378 · Data updated 2026-11-12
This registry collects medical records and tumor genetic data from children, teens, and young adults (1 month–39 years) newly diagnosed with very rare solid tumors to help researchers learn more and guide future treatments.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Month to 120 Years |
| Sex | All |
| Enrollment | 4000 (estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Status | Recruiting |
| Started | November 15, 2026 |
| Main results expected | April 1, 2035 |
| Study ends | April 1, 2037 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT07489378 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Patients aged 1 month to 39 years with a newly diagnosed (within one year) very rare solid tumor who have an established treating physician and can provide consent are ideal candidates.
✕Probably not a fit
Patients with excluded tumor types (for example, Ewing sarcoma, osteosarcoma, rhabdomyosarcoma, diffuse midline glioma H3K27‑altered, atypical teratoid rhabdoid tumor, pleuropulmonary blastoma, or common adult cancers presenting in pediatrics) or those diagnosed more than one year earlier are unlikely to qualify or receive direct benefit from this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a longitudinal observational registry run by the NCI Childhood Cancer Data Initiative that enrolls children, adolescents, and young adults (≤39 years at diagnosis) with very rare solid tumors diagnosed within the past year. Participation is remote by phone or email with no clinic visits required; researchers review medical records, request previously removed tumor tissue for molecular testing, and may mail saliva or cheek‑swab kits for germline samples. Molecular testing results are shared with the participant's treating physicians and standardized data are compiled into a central registry. The project aims to describe natural history, molecular features, and treatment patterns across fragmented rare‑tumor populations to enable future research and therapy development.
Why it matters
Potential benefit: If successful, the registry could improve diagnostic accuracy, reveal actionable molecular targets, and accelerate development of new treatments for very rare pediatric and AYA solid tumors.
How similar studies have gone: Other rare‑cancer registries and genomic initiatives have successfully improved understanding and led to targeted therapies for some rare tumors, although many pediatric very‑rare tumor types remain understudied.
Who can join: the full rules
Show full inclusion / exclusion criteria
* 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.
Where it's running
-
National Institutes of Health Clinical Center
Bethesda, Maryland, United States Recruiting
Study contacts
- Principal investigator: Mary F Wedekind Malone, D.O. — National Cancer Institute (NCI)
- Study coordinator: Mary F Wedekind Malone, D.O.
- Email: maryfrances.wedekindmalone@nih.gov
- Phone: (240) 858-3765
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
SumMET: Targeted radioligand therapy for c-MET–positive solid tumors
This first‑in‑human study tests the safety and potential effectiveness of a radioligand therapy called [225Ac]Ac-FL-261 in adults with advanced or metastatic solid tumors that overexpress c-MET.
-
SHR-4595 Injection in Advanced Solid Tumors: Safety, Tolerability, and Dosing in Phase 1
This early-phase trial tests SHR-4595 injections to see if they are safe and tolerable for adults with advanced solid tumors who have exhausted standard treatments.
-
FAPI PET imaging with FAPI-RuiJ and FAPI-04 in solid tumors
This study tests two FAP-targeted PET tracers (FAPI-RuiJ and FAPI-04) to see which better detects, stages, and monitors solid tumors.
-
Trop-2 Targeted PET/CT for Recurrent and Metastatic Thyroid Cancer
This study tests whether a Trop-2 targeted PET/CT scan can better detect recurrent or metastatic thyroid cancer in adults than another PET/CT scan (FAPI).
-
SI-B036 in locally advanced or metastatic breast cancer and other solid tumors
Scientists are testing SI-B036 to see if it is safe and tolerable in adults with advanced breast cancer or other solid tumors and to get early signals of whether it might help.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.