Last reviewed · How we verify

NCT03382158

International PPB/DICER1 Registry

Recruiting now Last updated 30 January 2025
What this trial tests

trial in Pleuropulmonary Blastoma in 3,400 participants. Currently enrolling.

Timeline
6 December 2016
Primary endpoint
6 December 2030
6 December 2035

Quick facts

Lead sponsorChildren's Hospitals and Clinics of Minnesota
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment3,400
Start date6 December 2016
Primary completion6 December 2030
Estimated completion6 December 2035
Sites1 location across United States

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. Prevalence of lung cysts in adolescents and adults with a germline &lt;i&gt;DICER1&lt;/i&gt; pathogenic/likely pathogenic variant: a report from the National Institutes of Health and International Pleuropulmonary Blastoma/&lt;i&gt;DICER1&lt;/i&gt; Registry.
    Nelson AT, Vasta LM, Watson D, Kim J, et al · · 2024 · cited 11× · PMID 38508719 · DOI 10.1136/thorax-2023-221024
  7. 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
  8. 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:

Other recruiting trials for Pleuropulmonary Blastoma

Currently open trials in the same condition.

Other Children's Hospitals and Clinics of Minnesota trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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