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Collecting and Storing Tissue From Young Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00898755
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief 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.

Condition or disease Intervention/treatment
Acute Lymphoblastic Leukemia Ann Arbor Stage I Childhood Burkitt Lymphoma Ann Arbor Stage I Childhood Hodgkin Lymphoma Ann Arbor Stage I Childhood Lymphoblastic Lymphoma Ann Arbor Stage I Non-Hodgkin Lymphoma Ann Arbor Stage II Childhood Burkitt Lymphoma Ann Arbor Stage II Childhood Hodgkin Lymphoma Ann Arbor Stage II Childhood Lymphoblastic Lymphoma Ann Arbor Stage II Non-Hodgkin Lymphoma Ann Arbor Stage III Childhood Burkitt Lymphoma Ann Arbor Stage III Childhood Hodgkin Lymphoma Ann Arbor Stage III Childhood Lymphoblastic Lymphoma Ann Arbor Stage III Non-Hodgkin Lymphoma Ann Arbor Stage IV Childhood Burkitt Lymphoma Ann Arbor Stage IV Childhood Hodgkin Lymphoma Ann Arbor Stage IV Childhood Lymphoblastic Lymphoma Ann Arbor Stage IV Non-Hodgkin Lymphoma Brain Stem Glioma Cerebellar Astrocytoma Childhood Acute Lymphoblastic Leukemia in Remission Childhood Acute Myeloid Leukemia in Remission Childhood Alveolar Rhabdomyosarcoma Childhood Atypical Teratoid/Rhabdoid Tumor Childhood Burkitt Lymphoma Childhood Central Nervous System Choriocarcinoma Childhood Central Nervous System Embryonal Neoplasm Childhood Central Nervous System Germ Cell Tumor Childhood Central Nervous System Germinoma Childhood Central Nervous System Mixed Germ Cell Tumor Childhood Central Nervous System Teratoma Childhood Central Nervous System Yolk Sac Tumor Childhood Cerebral Anaplastic Astrocytoma Childhood Cerebral Astrocytoma Childhood Choroid Plexus Neoplasm Childhood Chronic Myelogenous Leukemia, BCR-ABL1 Positive Childhood Craniopharyngioma Childhood Extracranial Germ Cell Tumor Childhood Extragonadal Malignant Germ Cell Tumor Childhood Germ Cell Tumor Childhood Grade I Meningioma Childhood Grade II Meningioma Childhood Grade III Lymphomatoid Granulomatosis Childhood Grade III Meningioma Childhood Hepatocellular Carcinoma Childhood Immunoblastic Lymphoma Childhood Infratentorial Ependymoma Childhood Langerhans Cell Histiocytosis Childhood Malignant Ovarian Germ Cell Tumor Childhood Malignant Testicular Germ Cell Tumor Childhood Myelodysplastic Syndrome Childhood Solid Neoplasm Childhood Supratentorial Ependymoma Childhood Teratoma de Novo Myelodysplastic Syndrome Ependymoma Extraocular Retinoblastoma Extraskeletal Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Hepatoblastoma Intraocular Retinoblastoma Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Localized Osteosarcoma Localized Resectable Neuroblastoma Localized Unresectable Neuroblastoma Medulloblastoma Metastatic Childhood Soft Tissue Sarcoma Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Metastatic Osteosarcoma Myelodysplastic Syndrome Myeloid Neoplasm Newly Diagnosed Childhood Ependymoma Non-Hodgkin Lymphoma Non-Metastatic Childhood Soft Tissue Sarcoma Previously Treated Childhood Rhabdomyosarcoma Previously Treated Myelodysplastic Syndrome Rare Childhood Malignant Neoplasm Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Acute Myeloid Leukemia Recurrent Childhood Brain Stem Glioma Recurrent Childhood Central Nervous System Embryonal Neoplasm Recurrent Childhood Cerebellar Astrocytoma Recurrent Childhood Cerebral Astrocytoma Recurrent Childhood Ependymoma Recurrent Childhood Grade III Lymphomatoid Granulomatosis Recurrent Childhood Kidney Neoplasm Recurrent Childhood Liver Cancer Recurrent Childhood Lymphoblastic Lymphoma Recurrent Childhood Malignant Germ Cell Tumor Recurrent Childhood Medulloblastoma Recurrent Childhood Rhabdomyosarcoma Recurrent Childhood Soft Tissue Sarcoma Recurrent Childhood Supratentorial Embryonal Tumor, Not Otherwise Specified Recurrent Childhood Visual Pathway Glioma Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Recurrent Neuroblastoma Recurrent Non-Hodgkin Lymphoma Recurrent Osteosarcoma Recurrent Retinoblastoma Refractory Childhood Hodgkin Lymphoma Regional Neuroblastoma Rhabdoid Tumor of the Kidney Rhabdomyosarcoma Secondary Myelodysplastic Syndrome Stage 4 Neuroblastoma Stage 4S Neuroblastoma Stage I Childhood Hepatocellular Carcinoma AJCC v6 and v7 Stage I Kidney Wilms Tumor Stage II Childhood Hepatocellular Carcinoma AJCC v6 and v7 Stage II Kidney Wilms Tumor Stage III Childhood Hepatocellular Carcinoma AJCC v7 Stage III Kidney Wilms Tumor Stage IV Childhood Hepatocellular Carcinoma AJCC v7 Stage IV Kidney Wilms Tumor Stage V Kidney Wilms Tumor Supratentorial Embryonal Tumor, Not Otherwise Specified Untreated Childhood Acute Lymphoblastic Leukemia Untreated Childhood Brain Stem Glioma Untreated Childhood Cerebellar Astrocytoma Untreated Childhood Medulloblastoma Untreated Childhood Myeloid Neoplasm Untreated Childhood Rhabdomyosarcoma Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor Untreated Childhood Visual Pathway Glioma Visual Pathway Glioma Other: Cytology Specimen Collection Procedure Other: Laboratory Biomarker Analysis

Detailed 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.


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Study Type : Observational
Actual Enrollment : 202 participants
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

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Childhood Acute Lymphoblastic Leukemia Soft Tissue Sarcoma Lymphosarcoma Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Glioma Burkitt Lymphoma Neuroblastoma Myelodysplastic Syndromes Anaplastic Astrocytoma Meningioma Lymphoblastic Lymphoma Craniopharyngioma Hodgkin Lymphoma Ewing Sarcoma Ewing's Family of Tumors Osteosarcoma Rhabdoid Tumor Hepatoblastoma Chronic Myeloid Leukemia Testicular Cancer Retinoblastoma Medulloblastoma Neuroepithelioma Medulloblastoma, Childhood Ependymoma Wilms' Tumor Optic Pathway Glioma Hodgkin Lymphoma, Childhood Childhood Brain Stem Glioma Malignant Germ Cell Tumor Langerhans Cell Histiocytosis Childhood Hepatocellular Carcinoma Choriocarcinoma Rhabdomyosarcoma Alveolar Lymphomatoid Granulomatosis Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Supratentorial Primitive Neuroectodermal Tumor Ovarian Germ Cell Tumor Central Nervous System Germinoma Cerebellar Astrocytoma, Childhood Cerebral Astrocytoma, Childhood Childhood Supratentorial Embryonal Tumor, Not Otherwise Specified Ovarian Cancer Testicular Yolk Sac Tumor Ameloblastoma Lymphoma, Large-cell Chronic Myeloproliferative Disorders B-cell Lymphoma

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Establishment and banking of cell lines and/or xenografts from pediatric patients with cancer [ Time Frame: Up to 14 years ]
  2. Establishment of continuous cell lines, under carefully controlled conditions, from pediatric patients with cancer [ Time Frame: Up to 14 years ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. Characterization of cell lines for the ability for sustained growth in tissue culture and/or as mouse xenografts [ Time Frame: Up to 14 years ]
  7. Characterization of cell lines for mycoplasma contamination [ Time Frame: Up to 14 years ]
  8. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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
Criteria

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

Information from the National Library of Medicine

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


  Show 66 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Charles Reynolds Children's Oncology Group

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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00898755     History of Changes
Other Study ID Numbers: ABTR04B1
NCI-2009-00326 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ABTR04B1
ABTR04B1
CDR0000478867
ABTR04B1 ( Other Identifier: Childrens Oncology Group )
ABTR04B1 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: July 2016

Additional relevant MeSH terms:
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Lymphoma
Syndrome
Leukemia
Carcinoma
Neoplasms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Sarcoma
Myelodysplastic Syndromes
Preleukemia
Lymphoma, Non-Hodgkin
Carcinoma, Hepatocellular
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Glioma
Hodgkin Disease
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neuroblastoma
Burkitt Lymphoma
Liver Neoplasms
Neoplasms, Germ Cell and Embryonal
Astrocytoma
Osteosarcoma
Rhabdomyosarcoma
Ependymoma
Meningioma
Sarcoma, Ewing
Medulloblastoma
Germinoma
Ovarian Neoplasms