Collecting and Storing Tissue From Young Patients With Cancer
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ClinicalTrials.gov Identifier: NCT00898755 |
Recruitment Status :
Recruiting
First Posted : May 12, 2009
Last Update Posted : March 4, 2022
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Condition or disease | Intervention/treatment |
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Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Central Nervous System Neoplasm Ewing Sarcoma Germ Cell Tumor Leukemia Lymphoma Malignant Neoplasm Neuroblastoma Osteosarcoma Retinoblastoma Rhabdoid Tumor Rhabdomyosarcoma Soft Tissue Sarcoma | Other: Cytology Specimen Collection Procedure Other: Laboratory Biomarker Analysis |
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.
Study Type : | Observational |
Estimated Enrollment : | 213 participants |
Observational Model: | Case-Only |
Time Perspective: | Cross-Sectional |
Official Title: | Establishing Continuous Cell Lines and Xenografts From Pediatric Cancers for Biological and Pre-Clinical Therapeutic Studies |
Actual Study Start Date : | March 5, 2007 |
Actual Primary Completion Date : | July 17, 2008 |

Group/Cohort | Intervention/treatment |
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Ancillary-Correlative (tissue sample collection)
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 |
Other: Cytology Specimen Collection Procedure
Correlative studies
Other Name: Cytologic Sampling Other: Laboratory Biomarker Analysis Correlative studies |
- Establishment and banking of cell lines and/or xenografts from pediatric patients with cancer [ Time Frame: Up to 14 years ]
- Establishment of continuous cell lines, under carefully controlled conditions, from pediatric patients with cancer [ Time Frame: Up to 14 years ]
- Establishment of transplantable xenografts in immunocompromised mice from tumor cells that are difficult to establish as continuous cell lines in vitro [ Time Frame: Up to 14 years ]
- Creation of a bank of cell lines and generation of sufficient vials of cryopreserved cells for distribution to investigators with approved COG biology protocols [ Time Frame: Up to 14 years ]
- Characterization of cell lines from childhood cancers with respect to DNA PCR molecular HLA profile as a "fingerprint" of original cell line identity [ Time Frame: Up to 14 years ]
- Characterization of cell lines for the ability for sustained growth in tissue culture and/or as mouse xenografts [ Time Frame: Up to 14 years ]
- Characterization of cell lines for mycoplasma contamination [ Time Frame: Up to 14 years ]
- 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 [ Time Frame: Up to 14 years ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | up to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
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All malignant tissues from childhood cancers allowed including the following:
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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
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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
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Leukemias/lymphomas
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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
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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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898755

Principal Investigator: | Charles P Reynolds | Children's Oncology Group |
Responsible Party: | Children's Oncology Group |
ClinicalTrials.gov Identifier: | NCT00898755 |
Other Study ID Numbers: |
ABTR04B1 NCI-2009-00326 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CDR0000478867 COG-ABTR04B1 ABTR04B1 ABTR04B1 ( Other Identifier: Children's Oncology Group ) ABTR04B1 ( Other Identifier: CTEP ) U10CA098543 ( U.S. NIH Grant/Contract ) |
First Posted: | May 12, 2009 Key Record Dates |
Last Update Posted: | March 4, 2022 |
Last Verified: | March 2022 |
Neoplasms Leukemia Sarcoma Precursor Cell Lymphoblastic Leukemia-Lymphoma Neuroblastoma Osteosarcoma Rhabdomyosarcoma Sarcoma, Ewing Retinoblastoma Rhabdoid Tumor Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Leukemia, Lymphoid |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Bone Tissue Neoplasms, Connective Tissue Myosarcoma Neoplasms, Muscle Tissue |