Study of Key Late-Occurring Complications in Childhood Cancer Survivors

Active:	Yes
Cancer Type:	Multiple Primaries	NCT ID:	NCT00082745
Trial Phases:		Protocol IDs:	COG-ALTE03N1 (primary) ALTE03N1
Eligibility:	21 and under at diagnosis, any age at study entry, Male and Female	Study Type:	Natural history/Epidemiology
Study Sponsor:	Children's Oncology Group
NCI Full Details:	http://clinicaltrials.gov/ct/show/NCT00082745

Summary

Rationale

A patient's genes(JEEN)

The functional and physical unit of heredity passed from parent to offspring. Genes are pieces of DNA, and most genes contain the information for making a specific protein. may affect the risk of developing complications, such as congestive heart failure(hart FAYL-yer kun-JES-tiv hart FAYL-yer)

Weakness of the heart muscle that leads to a buildup of fluid in body tissues., heart attack, stroke, and second cancer(SEH-kund PRY-mayr-ee KAN-ser)

Refers to a new primary cancer in a person with a history of cancer., years after undergoing cancer treatment. Genetic(jeh-NEH-tik)

Inherited; having to do with information that is passed from parents to offspring through genes in sperm and egg cells. studies may help doctors identify survivors of childhood cancer who are more likely to develop late complications.

Purpose

This clinical trial(KLIH-nih-kul TRY-ul)

A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical study. is studying cancer survivors to identify those who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer.

Objectives

Identify key late-occurring complications, specifically, cardiac dysfunction (closed to accrual as of 4/17/09), myocardial infarction (closed to accrual as of 6/5/06), ischemic stroke, avascular necrosis (closed to accrual as of 11/26/08), and subsequent malignant neoplasm, in childhood cancer survivors.
Correlate key late-occurring complications with pathology and staging of the primary malignancy and therapeutic treatment protocol details in these patients.
Identify treatment-related and demographic risk factors by comparing patients who develop late-occurring complications (case group) vs those with the same primary malignancy who do not develop late-occurring complications (control group).
Compare the frequency of mutations or polymorphisms in specific candidate genes in both the case and control groups using constitutional DNA and RNA from both groups.
Explore the role and nature of gene-environment interaction in the development of late-occurring complications in these patients.

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston
1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

Study Coordinator:

Sindy Midoro

Doctors:

Lillian R. Meacham MD

Aflac Cancer and Blood Disorders Center of Children’s at Scottish Rite
5455 Meridian Mark Road
Suite 400
Atlanta, GA 30342
404-785-2215
www.choa.org

Study Coordinator:

Sindy Midoro

Doctors:

Lillian R. Meacham MD

Karen J. Wasilewski MD, MSCR

Augusta University Pediatric Cancer
1446 Harper Street
5th Floor
Augusta, GA 30912
www.augustahealth.org

Study Coordinator:

Kimberly Gray
(706)-721-3626

Doctors:

Afshin Ameri MD

Colleen H. McDonough MD

Cindy Neunert MD

Theodore S. Johnson MD

**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.