Collecting and Storing Tissue From Young Patients With Cancer

Sponsor

Children's Oncology Group (Other)

Overall Status

Recruiting

CT.gov ID

NCT00898755

Collaborator

National Cancer Institute (NCI) (NIH)

213

Enrollment

Locations

3.1

Patients Per Site

Study Details

Study Description

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	Phase
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:

Establish and bank cell lines and/or xenografts from pediatric patients with cancer.
Establish continuous cell lines, under carefully controlled conditions, from pediatric patients with cancer.
Establish transplantable xenografts in immunocompromised mice from tumor cells that are difficult to establish as continuous cell lines in vitro.
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.
Characterize cell lines for the ability for sustained growth in tissue culture and/or as mouse xenografts.
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).

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

Study Type:

Observational

Anticipated 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 :

Mar 5, 2007

Anticipated Primary Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	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 Names: Cytologic Sampling Other: Laboratory Biomarker Analysis Correlative studies

Arm

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 Names:

Cytologic Sampling

Other: Laboratory Biomarker Analysis

Correlative studies

Outcome Measures

Primary Outcome Measures

Establishment and banking of cell lines and/or xenografts from pediatric patients with cancer [Up to 14 years]
Establishment of continuous cell lines, under carefully controlled conditions, from pediatric patients with cancer [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 [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 [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 [Up to 14 years]
Characterization of cell lines for the ability for sustained growth in tissue culture and/or as mouse xenografts [Up to 14 years]
Characterization of cell lines for mycoplasma contamination [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 [Up to 14 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Alabama	Birmingham	Alabama	United States	35233
2	University of Alabama at Birmingham Cancer Center	Birmingham	Alabama	United States	35233
3	Arkansas Children's Hospital	Little Rock	Arkansas	United States	72202-3591
4	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
5	Kaiser Permanente Downey Medical Center	Downey	California	United States	90242
6	City of Hope Comprehensive Cancer Center	Duarte	California	United States	91010
7	Miller Children's and Women's Hospital Long Beach	Long Beach	California	United States	90806
8	Children's Hospital Los Angeles	Los Angeles	California	United States	90027
9	Children's Hospital and Research Center at Oakland	Oakland	California	United States	94609-1809
10	Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center	Denver	Colorado	United States	80218
11	Connecticut Children's Medical Center	Hartford	Connecticut	United States	06106
12	MedStar Georgetown University Hospital	Washington	District of Columbia	United States	20007
13	Lee Memorial Health System	Fort Myers	Florida	United States	33901
14	Golisano Children's Hospital of Southwest Florida	Fort Myers	Florida	United States	33908
15	Johns Hopkins All Children's Hospital	Saint Petersburg	Florida	United States	33701
16	Tampa General Hospital	Tampa	Florida	United States	33606
17	Saint Joseph's Hospital/Children's Hospital-Tampa	Tampa	Florida	United States	33607
18	Saint Mary's Hospital	West Palm Beach	Florida	United States	33407
19	Saint Luke's Mountain States Tumor Institute	Boise	Idaho	United States	83712
20	University of Illinois	Chicago	Illinois	United States	60612
21	Saint Jude Midwest Affiliate	Peoria	Illinois	United States	61637
22	Southern Illinois University School of Medicine	Springfield	Illinois	United States	62702
23	University of Kentucky/Markey Cancer Center	Lexington	Kentucky	United States	40536
24	Norton Children's Hospital	Louisville	Kentucky	United States	40202
25	Tulane University Health Sciences Center	New Orleans	Louisiana	United States	70112
26	Ochsner Medical Center Jefferson	New Orleans	Louisiana	United States	70121
27	Sinai Hospital of Baltimore	Baltimore	Maryland	United States	21215
28	Massachusetts General Hospital Cancer Center	Boston	Massachusetts	United States	02114
29	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
30	Wayne State University/Karmanos Cancer Institute	Detroit	Michigan	United States	48201
31	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
32	Kalamazoo Center for Medical Studies	Kalamazoo	Michigan	United States	49008
33	Columbia Regional	Columbia	Missouri	United States	65201
34	University of Missouri - Ellis Fischel	Columbia	Missouri	United States	65212
35	Children's Mercy Hospitals and Clinics	Kansas City	Missouri	United States	64108
36	Children's Hospital and Medical Center of Omaha	Omaha	Nebraska	United States	68114
37	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198
38	University Medical Center of Southern Nevada	Las Vegas	Nevada	United States	89102
39	Nevada Cancer Research Foundation CCOP	Las Vegas	Nevada	United States	89106
40	Sunrise Hospital and Medical Center	Las Vegas	Nevada	United States	89109
41	Alliance for Childhood Diseases/Cure 4 the Kids Foundation	Las Vegas	Nevada	United States	89135
42	Summerlin Hospital Medical Center	Las Vegas	Nevada	United States	89144
43	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
44	Morristown Medical Center	Morristown	New Jersey	United States	07960
45	Overlook Hospital	Summit	New Jersey	United States	07902
46	Albany Medical Center	Albany	New York	United States	12208
47	Montefiore Medical Center - Moses Campus	Bronx	New York	United States	10467
48	NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center	New York	New York	United States	10032
49	Carolinas Medical Center/Levine Cancer Institute	Charlotte	North Carolina	United States	28203
50	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
51	Children's Hospital Medical Center of Akron	Akron	Ohio	United States	44308
52	Rainbow Babies and Childrens Hospital	Cleveland	Ohio	United States	44106
53	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
54	Dayton Children's Hospital	Dayton	Ohio	United States	45404
55	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
56	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania	United States	15224
57	BI-LO Charities Children's Cancer Center	Greenville	South Carolina	United States	29605
58	Greenville Cancer Treatment Center	Greenville	South Carolina	United States	29605
59	East Tennessee Childrens Hospital	Knoxville	Tennessee	United States	37916
60	Texas Tech University Health Sciences Center-Amarillo	Amarillo	Texas	United States	79106
61	Driscoll Children's Hospital	Corpus Christi	Texas	United States	78411
62	Covenant Children's Hospital	Lubbock	Texas	United States	79410
63	UMC Cancer Center / UMC Health System	Lubbock	Texas	United States	79415
64	Methodist Children's Hospital of South Texas	San Antonio	Texas	United States	78229
65	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229
66	Madigan Army Medical Center	Tacoma	Washington	United States	98431
67	British Columbia Children's Hospital	Vancouver	British Columbia	Canada	V6H 3V4
68	Centre Hospitalier Universitaire Sainte-Justine	Montreal	Quebec	Canada	H3T 1C5
69	Saskatoon Cancer Centre	Saskatoon	Saskatchewan	Canada	S7N 4H4