Collecting and Storing Tissue From Young Patients With Cancer

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Brief Title

Collecting and Storing Tissue From Young Patients With Cancer

Official Title

Establishing Continuous Cell Lines and Xenografts From Pediatric Cancers for Biological and Pre-Clinical Therapeutic Studies

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.
    

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 Type

Observational


Primary Outcome

Establishment and banking of cell lines and/or xenografts from pediatric patients with cancer


Condition

Acute Lymphoblastic Leukemia

Intervention

Cytology Specimen Collection Procedure

Study Arms / Comparison Groups

 Ancillary-Correlative (tissue sample collection)
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

213

Start Date

March 5, 2007


Primary Completion Date

July 17, 2008

Eligibility 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
      

Gender

All

Ages

N/A - 21 Years

Accepts Healthy Volunteers

No

Contacts

Charles P Reynolds, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00898755

Organization ID

ABTR04B1

Secondary IDs

NCI-2009-00326

Responsible Party

Sponsor

Study Sponsor

Children's Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Charles P Reynolds, Principal Investigator, Children's Oncology Group


Verification Date

October 2020