Active — Not RecruitingNot Applicable

International Pleuropulmonary Blastoma (PPB) Treatment and Biology Registry

United States156 participantsStarted 2009-12-22

Plain-language summary

Pleuropulmonary Blastoma (PPB) is very rare and there is no established "standard" or "best" therapy. For many years, children with PPB around the world have been treated according to decisions made case-by-case in many different hospitals by many different physicians. No treatment has been tested in a large group of PPB patients. The goal is to treat many children with one treatment program and to learn the results of the treatment.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. Age : Patients from birth to \< 21 years of age at the time of diagnosis will be included in the Treatment and Biology Registry.
✓. Pathology Diagnosis: Patients with newly-diagnosed PPB Types I, II or III. Diagnosis is made by the local pathologist. Real-time central pathology review is encouraged but is not required. All cases must be submitted for central pathology review. Only centrally-reviewed cases confirmed as PPB will be analyzed prospectively.
✓. Prior Therapy: PPB Type I: All patients are eligible and will be followed in the study.
✓. Prior corticosteroid therapy is allowed.
✓. Patients who have received other chemotherapy regimens or radiation therapy will not be statistical analysis.
✓. Types II and III PPB patients with PRIOR Type I PPB diagnosis: Types II and III PPB cases which are recurrences of an earlier Type I PPB are included.
✓. Informed consent by patient or parent/guardian. (also, where appropriate: assent and HIPPA consent)

Exclusion criteria

✕. Inability of patient, or parent/guardian to obtain informed consent.
✕. Patients who have their PPB diagnosed ruled out by Registry central pathology review.

What they're measuring

Event-free survival

Timeframe: 5 years

Trial details

NCT IDNCT01464606

SponsorChildren's Hospitals and Clinics of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

View on ClinicalTrials.gov More Pleuropulmonary Blastoma trials