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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00898755
Other study ID # ABTR04B1
Secondary ID NCI-2009-00326CD
Status Recruiting
Phase
First received
Last updated
Start date March 5, 2007

Study information

Verified date January 2024
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This laboratory study is collecting and storing tissue, blood, and bone marrow samples from young patients with cancer. Collecting and storing samples of tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.


Description:

PRIMARY OBJECTIVES: I. Establish and bank cell lines and/or xenografts from pediatric patients with cancer. II. Establish continuous cell lines, under carefully controlled conditions, from pediatric patients with cancer. III. Establish transplantable xenografts in immunocompromised mice from tumor cells that are difficult to establish as continuous cell lines in vitro. IV. Create a bank of cell lines and generate sufficient vials of cryopreserved cells for distribution to investigators with approved COG biology protocols. V. Characterize cell lines from childhood cancers with respect to DNA short tandem repeat molecular profile as a "fingerprint" of original cell line identity. VI. Characterize cell lines for the ability for sustained growth in tissue culture and/or as mouse xenografts. VII. Characterize cell lines for mycoplasma contamination. VIII. Characterize cell lines for expression of molecular makers that confirm the tumor-type of the cell line and the immortal nature of the cells (telomerase) and the expression of molecular markers that may correlate with drug resistance. OUTLINE: This is a multicenter study. Specimens are stratified according to disease (acute lymphoblastic leukemia vs acute myeloid leukemia vs lymphoma vs osteogenic sarcoma vs Ewing family of tumors vs rhabdomyosarcoma vs primitive neuroectodermal tumor vs glioma vs astrocytoma vs rhabdoid tumors vs hepatoblastoma vs retinoblastoma vs Wilms tumor vs germ cell tumors vs other diagnoses). Leftover tissue from diagnostic procedures and/or surgery is cryopreserved and banked. Blood and/or bone marrow are also collected and banked. Cell lines are established and characterized via reverse-transcriptase polymerase chain reaction and/or flow cytometry for biomarkers and by DNA fingerprinting. Markers to be identified may include the following: NEUROBLASTOMA: tyrosine hydroxylase, protein gene product (PGP) 9.5, GD2, HLA class I, and HSAN 1.2 antigens EWING FAMILY OF TUMORS: EWS-FLI1, EWS-ERG, and PGP 9.5 RETINOBLASTOMA: interphotoreceptor retinoid-binding protein ACUTE LYMPHOBLASTIC LEUKEMIA: immunophenotype ALVEOLOR RHADOMYOSARCOMA: PAX3-FKHR, PAX7-FKHR, and MyoD1 ALL CELL TYPES: telomerase expression including hTR and hTERTMutations of TP53 gene are detected by flow cytometry and/or immunocytochemistry. No results of these tests are provided to the patient, the patient's physician, or the patient's medical records.


Recruitment information / eligibility

Status Recruiting
Enrollment 213
Est. completion date
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A to 21 Years
Eligibility Inclusion Criteria: - All malignant tissues from childhood cancers allowed including the following: - Brain tumors (all types) - Tissue should be submitted to CNS Committee Resource labs to be forwarded for this study, unless instructed otherwise on the COG web site - Ewing family of tumors - Rhabdomyosarcomas - Other soft tissue sarcomas - Osteogenic sarcomas - Rhabdoid tumors - Neuroblastomas - Viable material for cell culture for neuroblastoma is collected via COG-ANBL00B1 and should not be submitted via this study unless the patient cannot be enrolled on COG-ANBL00B1* - Retinoblastomas - Anaplastic Wilms tumor - Germ cell tumors - Leukemias/lymphomas - Acute myeloid leukemia (AML) - Blood samples and bone marrow samples from patients at second relapse and beyond may be submitted for this study - Bone marrow samples at diagnosis or first relapse must be submitted to an AML resource lab and will be forwarded for this study at the discretion of the AML Committee - Acute lymphoblastic leukemia (ALL) - Blood samples may be submitted directly to this study - Bone marrow samples must be submitted to an ALL resource lab and will be forwarded for this study at the discretion of the ALL Committee - Enrolled on a COG therapeutic, biology, or tissue banking protocol that allows collection of tissue for research and submission to a COG-designated resource laboratory - Participation in this protocol is not permitted until after tissue requirements for any active COG disease-specific therapeutic, biology, or banking protocols have been satisfied - Material may only be submitted for this protocol if tissue is available in excess of that required for satisfying active disease-specific therapeutic and biological protocols - Patients with diagnosis pending are eligible

Study Design


Intervention

Other:
Cytology Specimen Collection Procedure
Correlative studies
Laboratory Biomarker Analysis
Correlative studies

Locations

Country Name City State
Canada Centre Hospitalier Universitaire Sainte-Justine Montreal Quebec
Canada Saskatoon Cancer Centre Saskatoon Saskatchewan
Canada British Columbia Children's Hospital Vancouver British Columbia
United States Children's Hospital Medical Center of Akron Akron Ohio
United States Albany Medical Center Albany New York
United States Texas Tech University Health Sciences Center-Amarillo Amarillo Texas
United States Sinai Hospital of Baltimore Baltimore Maryland
United States Children's Hospital of Alabama Birmingham Alabama
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Saint Luke's Mountain States Tumor Institute Boise Idaho
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina
United States University of Illinois Chicago Illinois
United States Cleveland Clinic Foundation Cleveland Ohio
United States Rainbow Babies and Childrens Hospital Cleveland Ohio
United States Columbia Regional Columbia Missouri
United States University of Missouri - Ellis Fischel Columbia Missouri
United States Driscoll Children's Hospital Corpus Christi Texas
United States Dayton Children's Hospital Dayton Ohio
United States Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Kaiser Permanente Downey Medical Center Downey California
United States City of Hope Comprehensive Cancer Center Duarte California
United States Golisano Children's Hospital of Southwest Florida Fort Myers Florida
United States Lee Memorial Health System Fort Myers Florida
United States BI-LO Charities Children's Cancer Center Greenville South Carolina
United States Greenville Cancer Treatment Center Greenville South Carolina
United States Hackensack University Medical Center Hackensack New Jersey
United States Connecticut Children's Medical Center Hartford Connecticut
United States Bronson Methodist Hospital Kalamazoo Michigan
United States Kalamazoo Center for Medical Studies Kalamazoo Michigan
United States Children's Mercy Hospitals and Clinics Kansas City Missouri
United States East Tennessee Childrens Hospital Knoxville Tennessee
United States Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada
United States Nevada Cancer Research Foundation CCOP Las Vegas Nevada
United States Summerlin Hospital Medical Center Las Vegas Nevada
United States Sunrise Hospital and Medical Center Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States Arkansas Children's Hospital Little Rock Arkansas
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Miller Children's and Women's Hospital Long Beach Long Beach California
United States Children's Hospital Los Angeles Los Angeles California
United States Norton Children's Hospital Louisville Kentucky
United States Covenant Children's Hospital Lubbock Texas
United States UMC Cancer Center / UMC Health System Lubbock Texas
United States Morristown Medical Center Morristown New Jersey
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States Tulane University Health Sciences Center New Orleans Louisiana
United States NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York
United States Children's Hospital and Research Center at Oakland Oakland California
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Children's Hospital and Medical Center of Omaha Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States Saint Jude Midwest Affiliate Peoria Illinois
United States Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania
United States Johns Hopkins All Children's Hospital Saint Petersburg Florida
United States Methodist Children's Hospital of South Texas San Antonio Texas
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Southern Illinois University School of Medicine Springfield Illinois
United States Overlook Hospital Summit New Jersey
United States Madigan Army Medical Center Tacoma Washington
United States Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida
United States Tampa General Hospital Tampa Florida
United States MedStar Georgetown University Hospital Washington District of Columbia
United States Saint Mary's Hospital West Palm Beach Florida
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Establishment and banking of cell lines and/or xenografts from pediatric patients with cancer Up to 14 years
Primary Establishment of continuous cell lines, under carefully controlled conditions, from pediatric patients with cancer Up to 14 years
Primary Establishment of transplantable xenografts in immunocompromised mice from tumor cells that are difficult to establish as continuous cell lines in vitro Up to 14 years
Primary Creation of a bank of cell lines and generation of sufficient vials of cryopreserved cells for distribution to investigators with approved COG biology protocols Up to 14 years
Primary Characterization of cell lines from childhood cancers with respect to DNA PCR molecular HLA profile as a "fingerprint" of original cell line identity Up to 14 years
Primary Characterization of cell lines for the ability for sustained growth in tissue culture and/or as mouse xenografts Up to 14 years
Primary Characterization of cell lines for mycoplasma contamination Up to 14 years
Primary Characterization of cell lines for expression of molecular makers that confirm the tumor-type of the cell line and the immortal nature of the cells (telomerase) and the expression of molecular markers that may correlate with drug resistance Up to 14 years
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