| NCT ID | NCT03382158 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospitals and Clinics of Minnesota |
| Condition | Pleuropulmonary Blastoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,400 participants |
| Start Date | 2016-12-06 |
| Primary Completion | 2030-12-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,400 participants in total. It began in 2016-12-06 with a primary completion date of 2030-12-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Known or suspected PPB or related thoracic tumor 2. Known or suspected sex-cord stromal tumor including Sertoli-Leydig cell tumor and gynandroblastoma (males or females) 3. Other known or suspected DICER1-related condition including ovarian sarcoma, cystic nephroma, renal sarcoma, pineoblastoma, pituitary blastoma, nasal chondromesenchymal hamartoma, ciliary body medulloepithelioma and others 4. Individuals with known or suspected DICER1 pathogenic variation regardless of whether they have an established DICER1-associated condition 5. Informed consent by patient/ or parent/guardian (also, where appropriate: assent and HIPAA consent) Exclusion criteria: Absence of appropriate consent for Registry participation
Contact & Investigator
Kris Ann P Schultz, MD
PRINCIPAL INVESTIGATOR
Children's Minnesota
Frequently Asked Questions
Who can join the NCT03382158 clinical trial?
This trial is open to participants of all sexes, aged 0 Minutes or older, up to 100 Years, studying Pleuropulmonary Blastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03382158 currently recruiting?
Yes, NCT03382158 is actively recruiting participants. Contact the research team at krisann.schultz@childrensmn.org for enrollment information.
Where is the NCT03382158 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT03382158 clinical trial?
NCT03382158 is sponsored by Children's Hospitals and Clinics of Minnesota. The principal investigator is Kris Ann P Schultz, MD at Children's Minnesota. The trial plans to enroll 3,400 participants.