Last updated on April 2019

Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma


Brief description of study

This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To prospectively analyze the factors that are currently used for risk-group assignment (v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog [MYCN] copy number by fluorescent in situ hybridization [FISH], deoxyribonucleic acid [DNA] content by flow cytometry, and tumor histology using the International Neuroblastoma Pathologic Classification System) in neuroblastoma tumors at the time of diagnosis.

II. To maintain a reference bank containing clinically and genetically characterized frozen tumor tissue, tumor DNA and ribonucleic acid (RNA), histology slides and paraffin blocks, neuroblastoma-derived cell lines, patient serum and paired normal DNA obtained at the time of diagnosis, at the time of second-look surgery and at the time of relapse for future research studies.

III. To prospectively analyze 1p, 11q, 14q and 17q allelic status, MYCN copy number by quantitative polymerase chain reaction (PCR); and the expression pattern of neurotrophin-related genes in diagnostic neuroblastoma tumors, and assay for the presence of rare tumor cells in biological specimens by reverse transcription (RT)-PCR; these biological variables will be analyzed for independent clinical significance compared to MYCN amplification, International Neuroblastoma Staging System (INSS) stage, age, ploidy, and histologic variables in predicting either response to treatment or outcome.

IV. To build a database of the known biologic prognostic factors for patients on therapeutic studies.

V. To serve as a Registry for neuroblastoma patients whose tumors demonstrate clinical and genetic features defined as ?Low Risk? for treatment failure in the absence of adjuvant therapy.

SECONDARY OBJECTIVES:

I. To prospectively analyze the concordance between detection of MYCN amplification in tumor samples and quantitative detection of MYCN DNA in serum, and to analyze the prognostic significance of MYCN amplification as detected in serum samples.

II. To build a database that includes information regarding the presentation and natural history of neuroblastoma-associated health problems including but not limited to opsoclonus myoclonus ataxia (OMA) and/or spinal cord compression.

OUTLINE

Patients undergo collection of blood, tissue, and bone marrow samples for analysis via RT-PCR, quantitative PCR, flow cytometry, and FISH.

After completion of study, patients are followed up periodically.

Clinical Study Identifier: NCT00904241

Find a site near you

Start Over

Saint Mary's Hospital

West Palm Beach, FL United States
  Connect »

University of Virginia Cancer Center

Charlottesville, VA United States
  Connect »

Sinai Hospital of Baltimore

Baltimore, MD United States
  Connect »

Tampa General Hospital

Tampa, FL United States
  Connect »

Kaiser Permanente-Oakland

Oakland, CA United States
  Connect »

Florida Hospital Orlando

Orlando, FL United States
  Connect »

Ochsner Medical Center Jefferson

New Orleans, LA United States
  Connect »

Mount Sinai Hospital

New York, NY United States
  Connect »

Baystate Medical Center

Springfield, MA United States
  Connect »

Saint Peter's University Hospital

New Brunswick, NJ United States
  Connect »

Children's Hospital of Alabama

Birmingham, AL United States
  Connect »

Phoenix Childrens Hospital

Phoenix, AZ United States
  Connect »

Arkansas Children's Hospital

Little Rock, AR United States
  Connect »

Children's Hospital Los Angeles

Los Angeles, CA United States
  Connect »

Mattel Children's Hospital UCLA

Los Angeles, CA United States
  Connect »

UCSF Medical Center-Parnassus

San Francisco, CA United States
  Connect »

UCSF Medical Center-Mission Bay

San Francisco, CA United States
  Connect »

Santa Barbara Cottage Hospital

Santa Barbara, CA United States
  Connect »

Yale University

New Haven, CT United States
  Connect »

Broward Health Medical Center

Fort Lauderdale, FL United States
  Connect »

Lee Memorial Health System

Fort Myers, FL United States
  Connect »

Nemours Children's Hospital

Orlando, FL United States
  Connect »

Johns Hopkins All Children's Hospital

Saint Petersburg, FL United States
  Connect »

Tripler Army Medical Center

Honolulu, HI United States
  Connect »

University of Illinois

Chicago, IL United States
  Connect »

Riley Hospital for Children

Indianapolis, IN United States
  Connect »

Blank Children's Hospital

Des Moines, IA United States
  Connect »

Norton Children's Hospital

Louisville, KY United States
  Connect »

Children's Hospital New Orleans

New Orleans, LA United States
  Connect »

Maine Children's Cancer Program

Scarborough, ME United States
  Connect »

C S Mott Children's Hospital

Ann Arbor, MI United States
  Connect »

Henry Ford Hospital

Detroit, MI United States
  Connect »

Hurley Medical Center

Flint, MI United States
  Connect »

Bronson Methodist Hospital

Kalamazoo, MI United States
  Connect »

Mayo Clinic

Rochester, MN United States
  Connect »

Columbia Regional

Columbia, MO United States
  Connect »

The Childrens Mercy Hospital

Kansas City, MO United States
  Connect »

Mercy Hospital Saint Louis

Saint Louis, MO United States
  Connect »

Saint Barnabas Medical Center

Livingston, NJ United States
  Connect »

Morristown Medical Center

Morristown, NJ United States
  Connect »

Overlook Hospital

Summit, NJ United States
  Connect »

Albany Medical Center

Albany, NY United States
  Connect »

Brooklyn Hospital Center

Brooklyn, NY United States
  Connect »

Maimonides Medical Center

Brooklyn, NY United States
  Connect »

University of Rochester

Rochester, NY United States
  Connect »

New York Medical College

Valhalla, NY United States
  Connect »

East Carolina University

Greenville, NC United States
  Connect »

Cleveland Clinic Foundation

Cleveland, OH United States
  Connect »

Mercy Children's Hospital

Toledo, OH United States
  Connect »

Geisinger Medical Center

Danville, PA United States
  Connect »

Rhode Island Hospital

Providence, RI United States
  Connect »

Palmetto Health Richland

Columbia, SC United States
  Connect »

T C Thompson Children's Hospital

Chattanooga, TN United States
  Connect »

East Tennessee State University

Johnson City, TN United States
  Connect »

Driscoll Children's Hospital

Corpus Christi, TX United States
  Connect »

El Paso Children's Hospital

El Paso, TX United States
  Connect »

Brooke Army Medical Center

Fort Sam Houston, TX United States
  Connect »

Cook Children's Medical Center

Fort Worth, TX United States
  Connect »

M D Anderson Cancer Center

Houston, TX United States
  Connect »

Primary Children's Hospital

Salt Lake City, UT United States
  Connect »

Inova Fairfax Hospital

Falls Church, VA United States
  Connect »

Seattle Children's Hospital

Seattle, WA United States
  Connect »

Marshfield Clinic

Marshfield, WI United States
  Connect »

John Hunter Children's Hospital

Hunter Regional Mail Centre, Australia
  Connect »

Christchurch Hospital

Christchurch, New Zealand
  Connect »

Cedars Sinai Medical Center

Los Angeles, CA United States
  Connect »

Miami Cancer Institute

Miami, FL United States
  Connect »

NYU Winthrop Hospital

Mineola, NY United States
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.