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Study of Renal Tumors in Pediatric Patients

Status
Active
Cancer Type
Kidney Cancer
Trial Phase
Eligibility
Under 30, Male and Female
Study Type
Biomarker/Laboratory analysis
Natural history/Epidemiology
Tissue collection/Repository
NCT ID
NCT00898365
Protocol IDs
COG-AREN03B2 (primary)
AREN03B2
Study Sponsor
Children's Oncology Group
NCI Full Details
http://clinicaltrials.gov/ct/show/NCT00898365

Summary

Rationale

Collecting and storing 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., blood(blud)

A tissue with red blood cells, white blood cells, platelets, and other substances suspended in fluid called plasma. Blood takes oxygen and nutrients to the tissues, and carries away wastes., and urine(YOOR-in)

Fluid containing water and waste products. Urine is made by the kidneys, stored in the bladder, and leaves the body through the urethra. 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. to study in the laboratory may help doctors learn more about changes that occur in DNAThe molecules inside cells that carry genetic information and pass it from one generation to the next. Also called deoxyribonucleic acid. and identify 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. It may also help the study of cancer in the future.

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 kidney(KID-nee)

One of a pair of organs in the abdomen. Kidneys remove waste from the blood (as urine), produce erythropoietin (a substance that stimulates red blood cell production), and play a role in blood pressure regulation. tumors in young patients.

Objectives

Primary

  1. Classify patients with renal tumors by histological categorization, surgico-pathological stage, presence of metastases, age at diagnosis, tumor weight, and loss of heterozygosity for chromosomes 1p and 16q, to define eligibility for a series of therapeutic studies.
  2. Maintain a biological samples bank to make specimens available to scientists to evaluate additional potential biological prognostic variables and for the conduct of other research by scientists.

Secondary

  1. Monitor outcome for those patients who are not eligible for a subsequent therapeutic study.
  2. Describe whether the pulmonary tumor burden correlates with outcome in patients with stage IV disease.
  3. Describe the sensitivity and specificity of abdominal CT scan by comparing it with surgical and pathologic findings for identification of local tumor spread beyond the renal capsule to adjacent muscle and organs, lymph node involvement at the renal hilum and in the retroperitoneum, preoperative tumor rupture, and metastases to the liver.
  4. Compare the sensitivity and specificity of pre-operative abdominal CT scan and MRI for the identification and differentiation of nephrogenic rests and Wilms' tumor in children with multiple renal lesions.
  5. Correlate the method of conception (natural vs assisted reproductive technology) with the development of Wilms' tumor.
**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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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.