Last reviewed · How we verify
NCT03382158
International PPB/DICER1 Registry
trial in Pleuropulmonary Blastoma in 3,400 participants. Currently enrolling.
6 December 2030
Quick facts
| Lead sponsor | Children's Hospitals and Clinics of Minnesota |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 3,400 |
| Start date | 6 December 2016 |
| Primary completion | 6 December 2030 |
| Estimated completion | 6 December 2035 |
| Sites | 1 location across United States |
Conditions studied
- Pleuropulmonary Blastoma — all drugs for Pleuropulmonary Blastoma →
- Sertoli-Leydig Cell Tumor — all drugs for Sertoli-Leydig Cell Tumor →
- DICER1 Syndrome — all drugs for DICER1 Syndrome →
- Cystic Nephroma — all drugs for Cystic Nephroma →
Sponsor
Children's Hospitals and Clinics of Minnesota
Who can join
Adults 0 Minutes to 100, any sex, with Pleuropulmonary Blastoma or Sertoli-Leydig Cell Tumor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Pleuropulmonary blastoma (PPB) is a rare malignant neoplasm of the lung presenting in early childhood. Type I PPB is a purely cystic lesion, Type II is a partially cystic, partially solid tumor, Type III is a completely solid tumor. Treatment of children with PPB is at the discretion of the treating institution. This study builds off of the 2009 study and will also seek to enroll individuals with DICER1-associated conditions, some of whom may present only with the DICER1 gene mutation, which will help the Registry understand how these tumors and conditions develop, their clinical course and the most effective treatments.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Outcomes for Children With Type II and Type III Pleuropulmonary Blastoma Following Chemotherapy: A Report From the International PPB/<i>DICER1</i> Registry.
Schultz KAP, Harris AK, Nelson AT, Watson D, et al · · 2023 · cited 23× · PMID 36137255 · DOI 10.1200/jco.21.02925 -
DICER1-Related Tumor Predisposition: Identification of At-risk Individuals and Recommended Surveillance Strategies.
Schultz KAP, Nelson AT, Mallinger PHR, Harris AK, et al · · 2024 · cited 15× · PMID 39400264 · DOI 10.1158/1078-0432.ccr-24-1532 -
Specifications of the ACMG/AMP Variant Classification Guidelines for Germline <i>DICER1</i> Variant Curation.
Hatton JN, Frone MN, Cox HC, Crowley SB, et al · · 2023 · cited 14× · PMID 38084291 · DOI 10.1155/2023/9537832 -
Outcomes in ovarian Sertoli-Leydig cell tumor: A report from the International Pleuropulmonary Blastoma/DICER1 and Ovarian and Testicular Stromal Tumor Registries.
Nelson AT, Harris AK, Watson D, Kamihara J, et al · · 2024 · cited 12× · PMID 38657450 · DOI 10.1016/j.ygyno.2024.04.005 -
Anaplastic sarcoma of the kidney (DICER1-sarcoma of the kidney): A report from the International Pleuropulmonary Blastoma/DICER1 Registry.
Schoettler PJ, Smith CC, Nishitani M, Harris AK, et al · · 2024 · cited 11× · PMID 38807260 · DOI 10.1002/pbc.31090 -
Prevalence of lung cysts in adolescents and adults with a germline <i>DICER1</i> pathogenic/likely pathogenic variant: a report from the National Institutes of Health and International Pleuropulmonary Blastoma/<i>DICER1</i> Registry.
Nelson AT, Vasta LM, Watson D, Kim J, et al · · 2024 · cited 11× · PMID 38508719 · DOI 10.1136/thorax-2023-221024 -
Landscape of germline cancer predisposition mutations testing and management in pediatrics: Implications for research and clinical care.
Shahani SA, Marcotte EL. · · 2022 · cited 11× · PMID 36225340 · DOI 10.3389/fped.2022.1011873 -
Nasal chondromesenchymal hamartomas in a cohort with pathogenic germline variation in <i>DICER1</i>.
Vasta LM, Nichols A, Harney LA, Best AF, et al · · 2020 · cited 9× · PMID 34164613 · DOI 10.4193/rhinol/20.007
Verify or expand the search:
- PubMed search for NCT03382158
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Pleuropulmonary Blastoma
Currently open trials in the same condition.
- NCT06647953 — Testing a Standardized Approach to Surgery and Chemotherapy for Type I Pleuropulmonary Blastoma or the Addition of an An · Phase 3 · recruiting
- NCT07072143 — An International Study on Pediatric Patients With Rare Tumors. · recruiting
- NCT01247597 — DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study · recruiting
Other Children's Hospitals and Clinics of Minnesota trials
Trials by the same sponsor.
- NCT07482982 — Firearm Screening in the Pediatric Emergency Department · NA · completed
- NCT05283434 — Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries · Phase 2, PHASE3 · unknown
- NCT04575649 — Neurodevelopmental Outcomes and Growth in Infants With Congenital Gastrointestinal Anomalies Requiring Neonatal Surgery · unknown
- NCT03360643 — Point-of-Care Ultrasonography for Intussusception · NA · completed
- NCT03522233 — Pediatric Appendicitis Risk Calculator (pARC) in Children With Appendix Ultrasounds · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03382158 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospitals and Clinics of Minnesota
- Last refreshed: 30 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03382158.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing