Collecting and Storing Tissue From Young Patients With Cancer

NCT ID: NCT00898755

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

213 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-05

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

Cytology Specimen Collection Procedure

Intervention Type OTHER

Correlative studies

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Interventions

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Cytology Specimen Collection Procedure

Correlative studies

Intervention Type OTHER

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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Cytologic Sampling

Eligibility Criteria

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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
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Children's Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles P Reynolds

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

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Children's Hospital of Alabama

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Site Status

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Kaiser Permanente Downey Medical Center

Downey, California, United States

Site Status

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

Miller Children's and Women's Hospital Long Beach

Long Beach, California, United States

Site Status

Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status

Children's Hospital and Research Center at Oakland

Oakland, California, United States

Site Status

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Denver, Colorado, United States

Site Status

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Site Status

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status

Lee Memorial Health System

Fort Myers, Florida, United States

Site Status

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, United States

Site Status

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Site Status

Tampa General Hospital

Tampa, Florida, United States

Site Status

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, United States

Site Status

Saint Mary's Hospital

West Palm Beach, Florida, United States

Site Status

Saint Luke's Mountain States Tumor Institute

Boise, Idaho, United States

Site Status

University of Illinois

Chicago, Illinois, United States

Site Status

Saint Jude Midwest Affiliate

Peoria, Illinois, United States

Site Status

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Site Status

Norton Children's Hospital

Louisville, Kentucky, United States

Site Status

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

Site Status

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

Site Status

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status

Kalamazoo Center for Medical Studies

Kalamazoo, Michigan, United States

Site Status

Columbia Regional

Columbia, Missouri, United States

Site Status

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

Site Status

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

Site Status

Nevada Cancer Research Foundation CCOP

Las Vegas, Nevada, United States

Site Status

Sunrise Hospital and Medical Center

Las Vegas, Nevada, United States

Site Status

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, United States

Site Status

Summerlin Hospital Medical Center

Las Vegas, Nevada, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Morristown Medical Center

Morristown, New Jersey, United States

Site Status

Overlook Hospital

Summit, New Jersey, United States

Site Status

Albany Medical Center

Albany, New York, United States

Site Status

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Site Status

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Site Status

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Children's Hospital Medical Center of Akron

Akron, Ohio, United States

Site Status

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Dayton Children's Hospital

Dayton, Ohio, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Site Status

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, United States

Site Status

Greenville Cancer Treatment Center

Greenville, South Carolina, United States

Site Status

East Tennessee Childrens Hospital

Knoxville, Tennessee, United States

Site Status

Texas Tech University Health Sciences Center-Amarillo

Amarillo, Texas, United States

Site Status

Driscoll Children's Hospital

Corpus Christi, Texas, United States

Site Status

Covenant Children's Hospital

Lubbock, Texas, United States

Site Status

UMC Cancer Center / UMC Health System

Lubbock, Texas, United States

Site Status

Methodist Children's Hospital of South Texas

San Antonio, Texas, United States

Site Status

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

Madigan Army Medical Center

Tacoma, Washington, United States

Site Status

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

Site Status

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, Canada

Site Status

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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NCI-2009-00326

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000478867

Identifier Type: -

Identifier Source: secondary_id

COG-ABTR04B1

Identifier Type: -

Identifier Source: secondary_id

ABTR04B1

Identifier Type: -

Identifier Source: secondary_id

ABTR04B1

Identifier Type: OTHER

Identifier Source: secondary_id

ABTR04B1

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA098543

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ABTR04B1

Identifier Type: -

Identifier Source: org_study_id

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