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NCT01247597 · ClinicalTrials.gov registry record
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
A clinical trial of Pleuropulmonary Blastoma and Cystic Nephroma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- 1,500
- Enrollment target
- 2
- Study locations
NCT01247597: Recruiting study of Pleuropulmonary Blastoma and Cystic Nephroma, sponsored by National Cancer Institute (NCI).
NCT01247597 is a study of Pleuropulmonary Blastoma and Cystic Nephroma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 1,500 participants, above the 1,222-participant average among 3 other Pleuropulmonary Blastoma trials with a reported enrollment target (23% higher). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01247597, a study of Pleuropulmonary Blastoma and Cystic Nephroma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- 1,500 participants
- Enrollment target
- 2
- Study locations
Study Summary
Background: \- Pleuropulmonary blastoma (PPB) is a rare fast-growing lung tumor that is associated with other, rare tumor types. Most cases of PPB appear in children younger than 6 years of age. Recently, it has been shown that this condition can be inherited (e.g., mutation of the DICER1 gene). Researchers are studying both clinical and genetic aspects of this newly described condition. They are interested in collecting further medical history and genetic information on individuals and close relatives of individuals who have PPB or other rare associated tumors. Objectives: \- To study individuals with a personal or a family history of pleuropulmonary blastoma (PPB) or other rare tumors that can be associated with PPB (e.g., cystic nephroma, nasal chondromesenchymal hamartoma, ovarian Sertoli-Leydig cell tumors, ocular medulloepithelioma). Eligibility: * Individuals who have been diagnosed with PPB and/or PPB-related tumors. * Close blood relatives (e.g., parents, siblings, grandparents) of individuals who have been diagnosed with PPB and/or PPB-related tumors. Design: * Interested participants can enroll or inquire about this study by calling 1-800-518-8474. * Participants will be asked to complete family history and medical history questionnaires. They will complete the questionnaire if they are at least 18 years of age, or another person will complete the questionnaire if the key family member is too young to do so on his or her own. * Participants will be asked to sign a medical record release form to allow researchers to examine detailed medical history information. * Participants may be asked to have a physical examination and imaging studies, provide blood and saliva samples, or provide tumor tissue from prior biopsies or cancer surgeries. * Annually, participants will update the family history and individual information questionnaires to document important changes in medical history, and will also update the medical record release form. Participants m
Primary Outcome
To evaluate various parameters related to psychosocial and behavioral issues resulting from being a member of a family at increased risk of PPB.
Conditions Studied
Study Locations (2)
Maryland
- National Institutes of Health Clinical Center - Bethesda
- National Cancer Institute - Shady Grove - Rockville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,500 participants |
| Start Date | 2011-02-13 |
What NCT01247597 shows while recruiting
NCT01247597 is an observational study that tracks outcomes without assigning an intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus, above the 1,222-participant average among 3 other Pleuropulmonary Blastoma trials with a reported enrollment target (23% higher).
The record links to 5 conditions, with Pleuropulmonary Blastoma appearing as the primary indexed condition, and to 0 interventions.
NCT01247597 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01247597 about?
NCT01247597 is a clinical study titled "DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study". Background: \- Pleuropulmonary blastoma (PPB) is a rare fast-growing lung tumor that is associated with other, rare tumor types. Most cases of PPB appear in children younger than 6 years of age. Recently, it has been shown that this condition can be inherited (e.g., mutation of the DICER1 gene). Re...
What is the current status of trial NCT01247597?
This trial is currently recruiting. The enrollment target is 1,500 participants. The study started on 2011-02-13.
What conditions does trial NCT01247597 study?
This clinical trial studies the following conditions: Pleuropulmonary Blastoma, Cystic Nephroma, Nasal Chondromesenchymal Hamartoma, Ovarian Sertoli-Leydig Cell Tumors, Ocular Medulloepithelioma.
Who is sponsoring clinical trial NCT01247597?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01247597 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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