Understanding DICER1-related Cancer Predisposition Syndrome

This study is looking into a condition called DICER1-related Pleuropulmonary Blastoma (PPB) Cancer Predisposition Syndrome. PPB is a rare, fast-growing lung tumor, often seen in young children, that can be inherited. Researchers want to learn more about the medical history and genetics of individuals and their close family members who have PPB or other rare tumors linked to the DICER1 gene. The study aims to understand psychosocial and behavioral issues, develop management guidelines, and explore how genetics and environment interact in this condition. You may be able to join if you have PPB or other DICER1-related tumors, or if you have a known or suspected change in your DICER1 gene. The study is observational, meaning it will collect information without testing a specific treatment.

Study design
This is an observational study aiming to enroll 1500 participants, collecting information without a specific intervention.
What's involved
Participants will complete self-administered questionnaires, undergo clinical, epidemiologic, and genetic evaluations, have laboratory tests, and allow review of medical records and biospecimen collection.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, including psychosocial issues, management guidelines, and genetic/environmental interactions, are measured on an ongoing basis.

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NCT01247597

DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study

Recruiting
Not specifiedAges 1–99Observational
National Cancer Institute (NCI)
~1,500 participants
Updated 2026-08-28 on ClinicalTrials.gov

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Psychosocial and Behavioral Issues
Measured over On-going
+5 more outcomes measured
Pleuropulmonary Blastoma
Cystic Nephroma
Ovarian Sertoli-Leydig Cell Tumors
Ocular Medulloepithelioma
Nasal Chondromesenchymal Hamartoma
2 sites across 1 states
Maryland2
  • Douglas R Stewart, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Affected individual is defined as:
an individual with histologically-confirmed PPB and/or other DICER1-related tumors
an individual with a known or suspected DICER1 disease-associated variant
an individual from the general population with one or more of the unique tumors of the types associated with DICER1 including (but not exclusively), PPB, cystic nephroma, ovarian Sertoli-Leydig cell and other sex cord-stromal tumors, ocular medulloepithelioma, nasal chondromesenchymal hamartoma, Wilms tumor, embryonal rhabdomyosarcoma, pineoblastoma, pituitary blastoma, ovarian sarcoma, CNS sarcoma and/or thyroid cancer - regardless of their family history. Additional DICER1-related neoplasms may be identified in the future, and they will be added to the protocol as needed.
Unaffected individual is defined as:
a family member (such as parents, siblings, children, or extended family) of an affected participant without a known or suspected DICER1 disease-associated variant or condition and they will be controls.
All types and amounts of prior therapies are allowed.
There is no age restriction.
There is no restriction related to organ and marrow function.
Ability of the individual or their legal guardian or appropriate surrogate to understand, and their willingness to provide informed consent.
  • Psychosocial and Behavioral IssuesOn-going

    To evaluate various parameters related to psychosocial and behavioral issues resulting from being a member of a family at increased risk of PPB.

  • Management Guidelines & Risk-reduction StrategiesOn-going

    To develop evidence-based management guidelines for cancer prevention and risk-reduction strategies for PPB patients and their family members prior to and after obtaining answers to the questions/objectives above.

  • Genetic & Environmental InteractionsOn-going

    To identify differences between patients with a germline mutation in DICER1 (or another gene(s) from this pathway) who do develop cancer and those who do not develop cancer. These differences may include genotype/phenotype/cancer susceptibility differences, modifier genes (gene-gene interactions) and environmental risk factors (gene-environment interactions). The latter two may be informative for modification of cancer risk in the general population.

  • DICER1-Related Pleuropulmonary Blastoma Cancer Predisposition SyndromeOn-going

    To establish a cohort of patients with PPB and/or specific neoplasms of the PPB spectrum (cystic nephroma, nasal chondromesenchymal hamartoma, ovarian Sertoli-Leydig cell and other sex cord-stromal tumors, ocular medulloepithelioma, Wilms tumor, embryonal rhabdomyosarcoma, pineoblastoma, others to be defined), in order to determine the frequency of DICER1 germline mutations in these patients and their family members. This will also allow us to identify DICER1 mutation-negative patients who will be crucial for future gene discovery efforts.

  • Clinical PhenotypeOn-going

    To characterize the clinical phenotype of, and study the incident and prevalent cancer rates in, these patients and their family members, for all cancers combined, and for each type of cancer, and to identify and confirm the specific types of cancer and benign neoplasms associated with this disorder.

  • Biospecimen RepositoryOn-going

    To create a biospecimen repository of carefully-annotated tissue samples for use in subsequent etiologically-oriented translational research projects. These samples comprise an invaluable resource for current and future studies related to the etiology of, and outcomes following, the various neoplasms that are now known, or later found to be, part of the PPB syndrome.