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Sponsored by: |
St. Jude Children's Research Hospital |
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Information provided by: | St. Jude Children's Research Hospital |
ClinicalTrials.gov Identifier: | NCT00700414 |
This study aims to collect demographic and medical information including detailed family history of cancer of children and adolescents with adrenocortical tumors in order to learn more about the clinical and epidemiological aspects, treatment modalities, and outcome of patients with this rare disease, worldwide. In addition, investigators at St. Jude Children's Hospital plan to perform molecular studies of tumor cells aimed to clarify the role of the P53 gene and other genetic pathways in these tumors.
Condition |
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Adrenocortical Tumor |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | International Pediatric Adrenocortical Tumor Registry |
Peripheral blood sample Tumor Tissue (of any histology) Adrenocortical tumors
Estimated Enrollment: | 9999 |
Study Start Date: | May 2001 |
Adrenocortical tumors (ACT) are very rare in children and teenagers. Of all the new cases of cancer diagnosed each year in the United States and Europe in patients younger than 20 years old, only about 0.2% are ACT. Studies from several laboratories including St. Jude Children's Research Hospital have revealed that the majority of children with ACT, particularly those younger than 4 years of age, have constitutional P53 mutations. Some mutations, as exemplified by the R337H P53 germline mutation, in which the function of the mutant protein is relatively preserved, the history of cancer in the carriers and their families is relatively unremarkable. In other cases, the P53 mutated gene encodes a functionally-impaired protein that predicts for a pervasive history of familial cancer (Li-Fraumeni syndrome). Therefore, these observations have implications for genetic counseling of families with childhood ACT and underscore the importance of genotype-phenotype correlations in familial cancer syndromes.
The creation of a specific rare tumor registry provides a mechanism to collect information that cannot be gathered in a single institution. The analysis of the registry data would permit an overview of the clinical, epidemiological, current treatment standards, and survival data of these patients and thus create opportunities for research. It also may facilitate the development of treatment consensus among investigators who register their patients and help to design future studies. Moreover, the combined COG and IPACTR studies are expected to provide meaningful insight into the biology of ACT, including clinical phenotype/genotype relationships, treatment outcome and long-term follow-up data in subjects with this rare tumor. Finally, it would provide data on the long-term consequences of exposure to tumor-secreted androgens (found in more than 80% of the pediatric cases) on children's growth and development.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Age ≤ 21 years old at diagnosis of adrenocortical tumor Relatives of the ACT patients of any age with a diagnosis of malignant tumor
Inclusion Criteria (patients):
Exclusion Criteria (patients):
Parents/Relatives Inclusion Criteria:
Parents/Relatives Exclusion Criterion:
Contact: Carlos Galindo-Rodriguez, MD | 1-866-278-5833 | info@stjude.org |
United States, California | |
Stanford University | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Neyssa Marina, MD | |
Contact: Jennifer Lew, CRA | |
Principal Investigator: Neyssa Marina, MD | |
United States, Florida | |
ALL Children's Hospital/St. Petersburg Hospital | Recruiting |
St. Petersburg, Florida, United States, 33701 | |
Contact: Jerry Barbosa, MD | |
Principal Investigator: Jerry Barbosa, MD | |
United States, Ohio | |
The Children's Medical Center | Recruiting |
Dayton, Ohio, United States, 45404 | |
Contact: Mukund Dole, MD | |
Contact: Elva Blatt, RN. MS, CCRP | |
Principal Investigator: Mukund Dole, MD | |
United States, Oklahoma | |
St. Francis Hospital/Warren Clinic, INC. | Recruiting |
Tulsa, Oklahoma, United States, 74136 | |
Contact: Greg Kirkpatrick, MD | |
Principal Investigator: Greg Kirkpatrick, MD | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Adda Grimberg, MD | |
Principal Investigator: Adda Grimberg, MD | |
United States, Tennessee | |
St. Jude Children's Research Hospital | Recruiting |
Memphis, Tennessee, United States, 38105 | |
Contact: Carlos Galindo-Rodriguez, MD 866-278-5833 info@stjude.org | |
Principal Investigator: Carlos Rodriguez-Galindo, MD | |
Vanderbilt University Medical Center | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: James Whitlock, MD | |
Contact: Kate Von Wahlde | |
Principal Investigator: James Whitlock, MD | |
United States, Texas | |
Cook's Children's Medical Center | Recruiting |
Fort Worth, Texas, United States, 76104 | |
Contact: Meaghan Granger, MD | |
Contact: Amy Rowell, MS, CCRC | |
Principal Investigator: Meaghan Granger, MD | |
Brazil | |
Hospital de Clinicas/Universidad Federal Do Parana | Recruiting |
Campinas, Brazil | |
Contact: Bonald Cavalcante de Figueirdo, MD | |
Principal Investigator: Bonald Cavalcante de Figueirdo, MD | |
Chile | |
Hospital de Ninos Roberto del Rio | Recruiting |
Santiago, Chile | |
Contact: Myriam Campbell, MD | |
Principal Investigator: Myriam Campbell, MD | |
Honduras | |
Universidad Nacional Autonoma | Recruiting |
Tegucigalpa, Honduras | |
Contact: Ligia Fu, MD | |
Principal Investigator: Ligia Fu, MD |
Principal Investigator: | Carlos Galindo-Rodriguez, MD | St. Jude Children's Research Hospital |
Responsible Party: | St. Jude Children's Research Hospital ( Carlos Galindo-Rodriguez, MD ) |
Study ID Numbers: | IPACTR |
Study First Received: | June 13, 2008 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00700414 |
Health Authority: | United States: Institutional Review Board |
Adrenal Gland Neoplasms Endocrine System Diseases Adrenal Gland Diseases Endocrinopathy |
Adrenal Cortex Neoplasms Adrenal Cortex Diseases Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site |