Hepatoblastoma Biology Study and Tissue Bank

This study has been withdrawn prior to enrollment.
(national study, local site not responsible for any analysis/results/etc)
Sponsor:
Information provided by (Responsible Party):
Howard Katzenstein, Emory University
ClinicalTrials.gov Identifier:
NCT00228683
First received: September 27, 2005
Last updated: November 23, 2013
Last verified: November 2013
  Purpose

This is a study to collect and bank tissue specimens and blood from patients with Hepatoblastoma.


Condition Intervention
Hepatoblastoma
Procedure: Biology Study and Tissue Banking

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Hepatoblastoma Biology Study and Tissue Bank

Further study details as provided by Emory University:

Primary Outcome Measures:
  • To collect and bank Hepatoblastoma specimens. [ Time Frame: specimens will be banked indefinitely ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2005
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Biology Study and Tissue Banking
    Collection of specimens from Hepatoblastoma patients.
Detailed Description:

COG 9346 - Lay Summary

Hepatoblastoma Biology Study and Tissue Bank

Although tremendous improvement in the treatment of childhood cancer has resulted from the use of clinical trials, it is clear that additional significant progress will require a better understanding of the molecular makeup of pediatric malignancies. Hepatoblastoma, an embryonal tumor of the liver, is rare in the general population. It occurs in approximately 1 in 50,000 children. However, families affected with Familial Adenomatous Polyposis, in which there is a high incidence of colon cancer, have an 850 fold increase in the frequency of Hepatoblastoma. Hepatoblastoma also occurs in association with Beckwith-Wiedemann Syndrome. Thus the occurrence of Hepatoblastoma suggests the need for both careful investigations into the family history of malignancies in relatives, as well as a search for genetic alterations that may contribute to tumor development.

COG cancer researchers are trying to better understand the causes of Hepatoblastoma. They want to develop improved methods for treatment, diagnosis and possibly even prevention. The exact molecules or genes to be studied will change over time as progress in cancer research is made. Not every gene or molecule known to be involved in cancer will be studied. Researchers will choose to study only those genes or molecules which they think are most promising. At present, the study of at least three genes is planned.

In some cases these changes may be detected in normal tissues such as liver or blood cells. One of the genes to be studied is known as the APC gene. It is linked with colon cancer in adults. Rarely this gene can be passed on in families which are prone to develop both colon cancer and Hepatoblastoma. We don't know how common changes in this gene are in children with Hepatoblastoma. This study will try and figure out if this gene is commonly changed in Hepatoblastoma.

In addition to studying specific genes or molecules, geneticists (doctors who specialize in looking at genes) will look at the overall genetic content of tumors from some of the children involved in this study. This will be done by what is known as a karyotype or chromosome analysis. It is known that some Hepatoblasomas have extra copies of certain chromosomes. However, we do not know what effect these extra chromosomes might have on predicting which children will be most likely to respond to treatment. One of the goals of the study is to figure out what biological factors within the tumors, including extra chromosomes, might help predict which children will respond best to treatment. This will hopefully lead to better treatment of Hepatoblastoma.

A single extra blood sample will be taken from the patient for this study. We will take no more than 1 1/2 teaspoons of blood. This amount may be less for very small infants. We will also take a single blood sample (1 tablespoon) from the parent.

A portion of tumor tissue that is removed from the patient's surgery or biopsy will also be sent. No extra procedures will be done to get the tumor tissue. It will be taken during a surgery that is needed for standard care.

Patients will also be asked to complete a questionnaire about their background. They may also be asked to complete a follow-up questionnaire or to provide additional information in the future.

  Eligibility

Ages Eligible for Study:   6 Months to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with hepatoblastoma.

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228683

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Howard Katzenstein, MD Children's Healthcare of Atlanta
  More Information

No publications provided

Responsible Party: Howard Katzenstein, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00228683     History of Changes
Other Study ID Numbers: IRB00024899
Study First Received: September 27, 2005
Last Updated: November 23, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hepatoblastoma
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 24, 2014