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Research Study of Clinical, Genetic, and Biological Factors as Prognostic Values in Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma

Status
Active
Cancer Type
Neuroblastoma
Trial Phase
Eligibility
Under 31, Male and Female
Study Type
Biomarker/Laboratory analysis
Tissue collection/Repository
NCT ID
NCT00904241
Protocol IDs
COG-ANBL00B1 (primary)
ANBL00B1
Study Sponsor
Children's Oncology Group

Summary

Rationale

Studying samples of tumor(TOO-mer)

An abnormal mass of tissue that results when cells divide more than they should or do not die when they should. Tumors may be benign (not cancer), or malignant (cancer). Also called neoplasm.
tissue(TISH-oo)

A group or layer of cells that work together to perform a specific function.
from patients with cancer(KAN-ser)

A term for diseases in which abnormal cells divide without control and can invade nearby tissues. Cancer cells can also spread to other parts of the body through the blood and lymph systems. There are several main types of cancer. Carcinoma is a cancer that begins in the skin or in tissues that line or cover internal organs. Sarcoma is a cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue. Leukemia is a cancer that starts in blood-forming tissue such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the blood. Lymphoma and multiple myeloma are cancers that begin in the cells of the immune system. Central nervous system cancers are cancers that begin in the tissues of the brain and spinal cord. Also called malignancy.
in the laboratory may help doctors identify and learn more about biomarkers(BY-oh-MAR-ker)

A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. Also called molecular marker and signature molecule.
related to cancer.

Purpose

This laboratory study(LA-bruh-tor-ee STUH-dee)

Research done in a laboratory. A laboratory study may use special equipment and cells or animals to find out if a drug, procedure, or treatment is likely to be useful in humans. It may also be a part of a clinical trial, such as when blood or other samples are collected. These may be used to measure the effect of a drug, procedure, or treatment on the body.
is looking at biomarkers in tumor tissue samples from patients with newly diagnosed(DY-ug-NOH-sis)

The process of identifying a disease, such as cancer, from its signs and symptoms.
neuroblastoma(NOOR-oh-blas-TOH-muh)

Cancer that arises in immature nerve cells and affects mostly infants and children.
or ganglioneuroblastoma.

Objectives

  1. Evaluate the factors currently used for risk-group assignment (DNA content, MYCN copy number, and tumor histology) in patients with newly diagnosed neuroblastoma or ganglioneuroblastoma.
  2. Assess the prevalence of 1p, 11q, 14q loss of heterozygosity and gain of 17q; the expression of nerve growth factor and its high affinity (Trk-A) and low affinity (p75NTR) receptors; and telomerase activity in these patients.
  3. Compare the independent clinical significance of these biological factors with MYCN amplification, International Neuroblastoma Staging system stage, age, and histologic variables in predicting response to treatment or outcome in these patients.
  4. Maintain a reference bank containing clinically and genetically characterized frozen tumor tissue, tumor DNA and RNA, tumor touch preparations, histology slides and blocks, cell lines, and paired normal DNA obtained at time of diagnosis, second-look surgery, and relapse for future research studies.
  5. Build a database of known biological prognostic factors for patients on therapeutic studies.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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