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NCT01353300 Clinical Trial

Gene Mutation in Samples From Young Patients With Pleuropulmonary Blastoma Syndrome at Risk for Developing Cancer

Sarcoma Clinical Trial

Official title:
Investigation of DICER1 in Cystic Nephroma and Cystic Partially Differentiated Nephroblastoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01353300
Other study ID # AREN11B2
Secondary ID COG-AREN11B2NCI-
Status Completed
Phase N/A
First received May 12, 2011
Last updated July 7, 2016
Start date May 2011

Study information
Verified date July 2016
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

RATIONALE: The identification of gene mutations in young patients with pleuropulmonary blastoma syndrome may allow doctors to better understand the genetic processes involved in the development of some types of cancer, and may also help doctors identify patients who are at risk for cancer.

PURPOSE: This research study studies gene mutations in samples from young patients with pleuropulmonary blastoma syndrome at risk for developing cancer.

Description:

OBJECTIVES:

- To determine if DICER1 mutations contribute to tumor pathogenesis in cystic nephromas and cystic partially differentiated nephroblastomas outside of families with pleuropulmonary blastoma (PPB) syndrome.

OUTLINE: Archived DNA samples are analyzed for DICER1 mutation by qPCR and directly sequenced using BigDye Terminator chemistry. Results are then compared against the single nucleotide polymorphism (SNP) database.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group N/A to 120 Years
Eligibility DISEASE CHARACTERISTICS:

- Diagnosis of pleuropulmonary blastoma syndrome

- Normal tissue samples, if available

- Parental and sibling DNA samples, if available

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Genetic:
• DNA analysis

• cytogenetic analysis

• gene expression analysis

• gene rearrangement analysis

• mutation analysis

• polymerase chain reaction

• polymorphism analysis

Other:
• laboratory biomarker analysis

• medical chart review

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Relationship between DICER1 mutations and tumor pathogenesis in cystic nephromas and cystic partially differentiated nephroblastomas outside of families with PPB nephroblastomas No
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