Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228683
Status:
WITHDRAWN
Last Update Posted:
2013-11-26
First Post:
2005-09-27
Brief Title:
Hepatoblastoma Biology Study and Tissue Bank
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Hepatoblastoma Biology Study and Tissue Bank
Status:
WITHDRAWN
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
national study local site not responsible for any analysisresultsetc
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study to collect and bank tissue specimens and blood from patients with Hepatoblastoma
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 50000 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 dont 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 12 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 patients 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
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 50000 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 dont 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 12 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None