Studying Gene Expression in Samples From Patients With Rhabdoid Tumors

Kidney Cancer Clinical Trial

Official title:

Determination of the Frequency of BRG1 and BRM Loss in Rhabdoid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01553175
• Other study ID #: AREN12B5
• Secondary ID: COG-AREN12B5CDR0
• Status: Completed
• Phase: N/A
• First received: March 10, 2012
• Last updated: July 13, 2016
• Start date: March 2012

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: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and find biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

PURPOSE: This research trial studies gene expression in samples from patients with rhabdoid tumors.

Description:

OBJECTIVES:

• To determine if BRM is silenced in the majority, if not all, rhabdoid tumors by immunohistochemistry in primary tumors.

• To determine if BRG1 is silenced in the majority, if not all, rhabdoid tumors by immunohistochemistry in primary tumors.

• To determine if GATA1 and/or HDAC2 is overexpressed in the same tumors that lack BRM expression.

• To determine if BRM promoter polymorphisms correlate with loss of BRM expression in primary rhabdoid tumors.

• To determine how BRG1 is silenced in primary rhabdoid tumors by sequencing BRG1 exons in genomic DNA derived from frozen samples.

OUTLINE: Archived tumor tissue samples are analyzed for BRM, BRG1, GATA1, and/or HDAC2 expression by immunohistochemistry. BRM- and BRG1-negative samples are also analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Tumor samples from patients diagnosed with rhabdoid tumors

• Matched frozen tumor tissue from BRG1-negative tumors (preferred) or matched genomic DNA from tumors, 100 ng per tumor from BRG1-negative tumors

• Any source of DNA from BRG1-negative tumors (tumors, blood, etc.)

• Matched frozen tumor tissue from BRM-negative tumors to confirm that BRM is not mutated or altered but rather epigenetically suppressed when lost in rhabdoid tumors

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Carcinoma, Renal Cell
• Central Nervous System Neoplasms
• Kidney Cancer
• Kidney Neoplasms
• Nervous System Neoplasms
• Rhabdoid Tumor

Intervention

Genetic:
• DNA analysis

• gene expression analysis

• mutation analysis

• protein expression analysis

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

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	Absence or presence BRG1 and BRM expression in rhabdoid tumors			No
Primary	Mechanism of suppression of BRG1 and BRM genes			No