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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 : October 19, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 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

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.

Study Design
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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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 ]

Biospecimen Retention:   Samples With DNA
Lelftover tissue from diagnostic procedures and/or surgery, blood and bone marrow samples

Eligibility Criteria
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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
Study Population
Patients enrolled on the Children Oncology Group (COG) therapeutic, biologic, or tissue banking protocols that allow collection of tissue for research studies
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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Charles P Reynolds Children's Oncology Group
More Information
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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: October 19, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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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