Banking of Cell Lines and Xenografts for Biological and Pre-Clinical Therapeutic Studies from Pediatric Patients With Cancer
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information
Alternate Title
Collecting and Storing Tissue From Young Patients With Cancer
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| No phase specified | Biomarker/Laboratory analysis, Tissue collection/Repository | Active | 21 and under | COG-ABTR04B1
ABTR04B1, NCT00898755 |
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.
- 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.
- 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.
Entry Criteria
Disease Characteristics:
- All
malignant tissues from childhood cancers allowed including the following:
- 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
Prior/Concurrent Therapy:
Patient Characteristics:
Expected Enrollment
500
A total of 500 specimens per stratum will be accrued for this study.
Outcomes
Primary Outcome(s)Establishment and banking of cell lines and/or xenografts from pediatric patients with cancer
Establishment of continuous cell lines, under carefully controlled conditions, from pediatric patients with cancer
Establishment of transplantable xenografts in immunocompromised mice from tumor cells that are difficult
to establish as continuous cell lines in vitro
Creation of a bank of cell lines and generation of sufficient vials of cryopreserved cells for distribution to
investigators with approved COG biology protocols
Characterization of cell lines from childhood cancers with respect to DNA PCR molecular HLA profile as a “fingerprint” of original cell line identity
Characterization of cell lines for the ability for sustained growth in tissue culture and/or as mouse xenografts
Characterization of cell lines for mycoplasma contamination
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
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
- Alveolar rhabdomyosarcoma: PAX3-FKHR, PAX7-FKHR, and MyoD1
- All cell types: telomerase expression including hTR and hTERT
Mutations 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.
Trial Contact Information
Trial Lead Organizations
Children's Oncology Group
 | | |
| C. Patrick Reynolds, MD, PhD, Protocol chair
(Contact information may not be current)
| | |
|
| Barry Maurer, MD, PhD, Protocol co-chair | | |
|
Trial Sites
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| U.S.A. |
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| Alabama |
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Birmingham |
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| | UAB Comprehensive Cancer Center |
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| | Clinical Trials Office - UAB Comprehensive Cancer Center | |
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| Arkansas |
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Little Rock |
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| | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences |
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| | Clinical Trial Office - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
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| California |
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Duarte |
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| | City of Hope Comprehensive Cancer Center |
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| | Clinical Trials Office - City of Hope Comprehensive Cancer Center | |
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Email:
becomingapatient@coh.org |
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Long Beach |
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| | Jonathan Jaques Children's Cancer Center at Miller Children's Hospital |
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| | Jerry Finklestein | |
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Los Angeles |
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| | Southern California Permanente Medical Group |
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| | Robert Cooper | |
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| Colorado |
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Denver |
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| | Presbyterian - St. Luke's Medical Center |
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| | Clinical Trials Office - Presbyterian - St. Luke's Medical Center | |
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| Florida |
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Fort Myers |
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| | Lee Cancer Care of Lee Memorial Health System |
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| | Clinical Trials Office - Lee Cancer Care of Lee Memorial Health System | |
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Saint Petersburg |
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| | All Children's Hospital |
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| | Gregory Hale | |
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Tampa |
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| | St. Joseph's Cancer Institute at St. Joseph's Hospital |
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| | Clinical Trials Office - St. Joseph's Cancer Institute | |
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West Palm Beach |
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| | Kaplan Cancer Center at St. Mary's Medical Center |
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| | Narayana Gowda | |
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| Idaho |
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Boise |
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| | Mountain States Tumor Institute at St. Luke's Regional Medical Center |
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| | Eugenia Chang | |
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| Illinois |
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Peoria |
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| | Saint Jude Midwest Affiliate |
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| | Pedro De Alarcon | |
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Springfield |
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| | Simmons Cooper Cancer Institute |
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| | Clinical Trials Office - Simmons Cooper Cancer Institute | |
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| Kentucky |
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Lexington |
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| | Lucille P. Markey Cancer Center at University of Kentucky |
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| | Clinical Trials Office - Markey Cancer Center at University of Kentucky Chandler Medical Center | |
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Louisville |
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| | Kosair Children's Hospital |
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| | Clinical Trials Office - Kosair Children's Hospital | |
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Email:
CancerResource@nortonhealthcare.org |
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| Louisiana |
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Alexandria |
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| | Tulane Cancer Center Office of Clinical Research |
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| | Clinical Trials Office - Tulane Cancer Center | |
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| Maryland |
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Baltimore |
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| | Alvin and Lois Lapidus Cancer Institute at Sinai Hospital |
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| | Joseph Wiley | |
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| Michigan |
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Detroit |
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| | Barbara Ann Karmanos Cancer Institute |
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| | Clinical Trials Office - Barbara Ann Karmanos Cancer Institute | |
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Kalamazoo |
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| | CCOP - Kalamazoo |
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| | Jeffrey Lobel | |
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| Missouri |
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Columbia |
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| | Ellis Fischel Cancer Center at University of Missouri - Columbia |
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| | Clinical Trial Office - Ellis Fischel Cancer Center | |
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Kansas City |
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| | Children's Mercy Hospital |
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| | Maxine Hetherington | |
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| Nevada |
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Las Vegas |
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| | CCOP - Nevada Cancer Research Foundation |
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| | Jonathan Bernstein | |
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| New Jersey |
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Hackensack |
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| | Hackensack University Medical Center Cancer Center |
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| | Clinical Trials Office - Hackensack University Medical Center Cancer Center | |
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Morristown |
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| | Overlook Hospital |
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| | Steven Halpern | |
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| New York |
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Brooklyn |
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| | Maimonides Cancer Center at Maimonides Medical Center |
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| | Contact Person | |
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New York |
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| | Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center |
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| | Clinical Trials Office - Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | |
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| North Carolina |
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Charlotte |
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| | Blumenthal Cancer Center at Carolinas Medical Center |
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| | Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center | |
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Winston-Salem |
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| | Wake Forest University Comprehensive Cancer Center |
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| | Clinical Trials Office - Wake Forest University Comprehensive Cancer Center | |
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| Ohio |
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Akron |
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| | Akron Children's Hospital |
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| | Clinical Trials Office - Akron Children's Hospital | |
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Cleveland |
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| | Cleveland Clinic Taussig Cancer Center |
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| | Clinical Trials Office - Cleveland Clinic Taussig Cancer Center | |
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| | Rainbow Babies and Children's Hospital |
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| | Yousif (Joe) Matloub | |
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Youngstown |
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| | Tod Children's Hospital |
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| | Clinical Trials Office - Tod Children's Hospital | |
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| Oklahoma |
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Oklahoma City |
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| | Oklahoma University Cancer Institute |
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| | Rene McNall-Knapp | |
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| Pennsylvania |
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Pittsburgh |
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| | Children's Hospital of Pittsburgh of UPMC |
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| | Clinical Trials Office - Children's Hospital of Pittsburgh | |
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| South Carolina |
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Greenville |
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| | Greenville Hospital Cancer Center |
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| | Clinical Trials Office - Greenville Hospital Cancer Center | |
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| Tennessee |
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Knoxville |
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| | East Tennessee Children's Hospital |
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| | Ray Pais | |
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| Texas |
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Amarillo |
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| | Texas Tech University Health Sciences Center School of Medicine - Amarillo |
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| | Osvaldo Regueira | |
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Lubbock |
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| | Covenant Children's Hospital |
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| | Latha Prasannan | |
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San Antonio |
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| | Methodist Children's Hospital of South Texas |
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| | Jaime Estrada | |
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| | University of Texas Health Science Center at San Antonio |
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| | Paul Thomas | |
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| Washington |
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Tacoma |
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| | Madigan Army Medical Center - Tacoma |
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| | Melissa Forouhar | |
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| Canada |
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| British Columbia |
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Vancouver |
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| | Children's and Women's Hospital of British Columbia |
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| | Caron Strahlendorf | |
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| Quebec |
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Montreal |
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| | Hopital Sainte Justine |
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| | Yvan Samson | |
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| Saskatchewan |
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Saskatoon |
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| | Saskatoon Cancer Centre at the University of Saskatchewan |
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| | Christopher Mpofu | |
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Related Information
PDQ® clinical trial COG-ANBL00B1
| Registry Information |
|
| Official Title | | Establishing Continuous Cell Lines and Xenografts from Pediatric Cancers for Biological and Pre-Clinical Therapeutic Studies |
|
| Trial Start Date | | 2007-03-05 |
|
| Registered in ClinicalTrials.gov | | NCT00898755 |
|
| Date Submitted to PDQ | | 2006-03-28 |
|
| Information Last Verified | | 2012-02-08 |
|
| NCI Grant/Contract Number | | CA98543 |
Note: The purpose of some clinical studies is to help researchers learn more about how cancer cells grow and how drugs are used in the body. Cells and tissues collected from cancer patients may be used to detect new biomarkers that may be important in diagnosing and treating cancer in the future. The procedure or lab test described in this clinical study is intended to be carried out by clinical oncologists and researchers in carefully structured settings. Individual results obtained from these studies may not be made available to patients.
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