S9007, Study of Bone Marrow and Blood Samples From Patien... | NCT00996047 | Trialant
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Studies S9007, Study of Bone Marrow and Blood Samples From Patients With Leukemia or Other Hematopoietic Cancers NCT00996047 Show options SWOG Cancer Research Network
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms cytogenetic analysis fluorescence in situ hybridization
Obsolete or Duplicate NCT IDs Not provided
ID Type Description Link SWOG-9007 Other Identifier SWOG U10CA032102 U.S. NIH Grant/Contract
S9007, Study of Bone Marrow and Blood Samples From Patients With Leukemia or Other Hematopoietic Cancers
S9007, Cytogenetic Studies in Leukemia Patients
SWOG Cancer Research Network NETWORK
Overall Recruitment Status or Expanded Access Status Completed
First Submission Date that Met QC Criteria Oct 15, 2009
Results First Submitted Date Not provided
Results First Submitted that Met QC Criteria Not provided
Results First Posted Date Not provided
Certification/Extension (aka Delayed Results) First Submitted Date Not provided
Certification/Extension First Submitted that Passed QC Review Not provided
Certification/Extension First Posted Date Not provided
Last Update Submitted Date Mar 5, 2015
Responsible Party, by Official Title Sponsor
SWOG Cancer Research Network NETWORK
Name Class National Cancer Institute (NCI) NIH Eastern Cooperative Oncology Group NETWORK
Has Data Monitoring Committee (DMC) No
Pediatric Postmarket Surveillance of a Device Product Not provided
RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is looking at bone marrow and blood samples from patients with leukemia or other hematopoietic cancers.
Primary objective:
* Maintain and expand a database of cytogenetic information on leukemia patients.
Other objectives as funding permits:
Determine the frequency and prognostic significance of cytogenetic abnormalities in bone marrow or peripheral blood cells in patients with leukemia prior to treatment and at various times during treatment undergoing treatment on a companion clinical trial.
Correlate the presence of cytogenetic features with clinical, pathophysiological, cellular, and molecular characteristics in these patients.
Provide quality control for all Southwest Oncology Group cytogenetic data.
OUTLINE: Bone marrow and/or peripheral blood samples from patients on specific treatment protocols for leukemia are analyzed for cytogenetic abnormalities. Samples from patients with chronic lymphocytic leukemia (CLL) are analyzed for trisomy 12 by fluorescence in situ hybridization and conventional cytogenetics.
PROJECTED ACCRUAL: Approximately 2,500 patients (1,200 with first-line acute myeloid leukemia [AML], 500 with first-line acute lymphoblastic leukemia [ALL], 200 with relapsed AML, 125 with chronic phase chronic myelogenous leukemia [CML], 100 with accelerated phase or blastic phase CML, 250 with hairy cell leukemia, and 125 with relapsed ALL or CLL) will be accrued for this study within 5 years.
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms untreated adult acute lymphoblastic leukemia accelerated phase chronic myelogenous leukemia acute undifferentiated leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) atypical chronic myeloid leukemia, BCR-ABL1 negative blastic phase chronic myelogenous leukemia childhood acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission Number of References to an Expanded Access Study Not provided
Target Follow-Up Duration Not provided
No data available
No data is available for this block.
Name Type Description Arm Group Labels Other Names cytogenetic analysis Genetic fluorescence in situ hybridization Genetic
Measure Description Time Frame Maintain and expand a database of cytogenetic information on leukemia patients. While protocol was open
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Accepts Healthy Volunteers No
Patients registered to SWOG leukemia treatment protocols
Name Affiliation Role Elisabeth Paietta, PhD Our Lady of Mercy Medical Center Study Chair
Facility Status City State ZIP Country Contacts Providence Cancer Center at Providence Hospital Mobile Alabama 36608 United States Providence Cancer Center
PubMed Identifier Type Citation Retractions Background Wolman SR, Gundacker HM, Slovak ML, et al.: Impact of trisomy 8(+8) on clinical presentation, treatment response, and survival in myeloid leukemia patients in Southwest Oncology Group (SWOG) trials. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1125, 282a, 2001. Result Norwood TH, Gundacker HM, Slovak ML, et al.: Changes in the pattern of cytogenetic aberrations with advancing age in acute myeloid (Non-APL) leukemia: a Southwest Oncology study (S9007). [Abstract] Blood 108 (11): A-808, 2006.
Available IPD Information Not provided
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childhood chronic myelogenous leukemia
chronic myelomonocytic leukemia
chronic phase chronic myelogenous leukemia
juvenile myelomonocytic leukemia
mast cell leukemia
meningeal chronic myelogenous leukemia
progressive hairy cell leukemia, initial treatment
prolymphocytic leukemia
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
recurrent childhood acute lymphoblastic leukemia
recurrent childhood acute myeloid leukemia
refractory chronic lymphocytic leukemia
refractory hairy cell leukemia
relapsing chronic myelogenous leukemia
secondary acute myeloid leukemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
T-cell large granular lymphocyte leukemia
untreated adult acute myeloid leukemia
untreated childhood acute lymphoblastic leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies
untreated hairy cell leukemia
childhood myelodysplastic syndromes
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
myelodysplastic/myeloproliferative neoplasm, unclassifiable
myelodysplastic/myeloproliferative neoplasms None Retained
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Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas 67214 United States
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Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan 48236 United States
Foote Memorial Hospital Jackson Michigan 49201 United States
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West Michigan Cancer Center Kalamazoo Michigan 49007-3731 United States
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Sparrow Regional Cancer Center Lansing Michigan 48912-1811 United States
St. Mary Mercy Hospital Livonia Michigan 48154 United States
Mercy General Health Partners Muskegon Michigan 49443 United States
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Munson Medical Center Traverse City Michigan 49684 United States
St. John Macomb Hospital Warren Michigan 48093 United States
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ID Term D007938 Leukemia D009190 Myelodysplastic Syndromes D054437 Myelodysplastic-Myeloproliferative Diseases D015465 Leukemia, Myeloid, Accelerated Phase D015456 Leukemia, Biphenotypic, Acute D000013 Congenital Abnormalities D054438 Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative D001752 Blast Crisis D015477 Leukemia, Myelomonocytic, Chronic D015466 Leukemia, Myeloid, Chronic-Phase D054429 Leukemia, Myelomonocytic, Juvenile D007946 Leukemia, Mast-Cell D015463 Leukemia, Prolymphocytic D054198 Precursor Cell Lymphoblastic Leukemia-Lymphoma D015470 Leukemia, Myeloid, Acute D015451 Leukemia, Lymphocytic, Chronic, B-Cell D007943 Leukemia, Hairy Cell D054066 Leukemia, Large Granular Lymphocytic D009196 Myeloproliferative Disorders
ID Term D009370 Neoplasms by Histologic Type D009369 Neoplasms D006402 Hematologic Diseases D006425 Hemic and Lymphatic Diseases D001855 Bone Marrow Diseases D015464 Leukemia, Myelogenous, Chronic, BCR-ABL Positive D007951 Leukemia, Myeloid D002908 Chronic Disease D020969 Disease Attributes D010335 Pathologic Processes D013568 Pathological Conditions, Signs and Symptoms D007945 Leukemia, Lymphoid D008232 Lymphoproliferative Disorders D008206 Lymphatic Diseases D007160 Immunoproliferative Disorders D007154 Immune System Diseases D009358 Congenital, Hereditary, and Neonatal Diseases and Abnormalities D002471 Cell Transformation, Neoplastic D063646 Carcinogenesis D009385 Neoplastic Processes D034721 Mastocytosis, Systemic D008415 Mastocytosis D000090362 Mast Cell Activation Disorders D015448 Leukemia, B-Cell D015458 Leukemia, T-Cell
ID Term D020732 Cytogenetic Analysis D017404 In Situ Hybridization, Fluorescence
ID Term D003584 Cytological Techniques D019411 Clinical Laboratory Techniques D019937 Diagnostic Techniques and Procedures D003933 Diagnosis D008919 Investigative Techniques D005821 Genetic Techniques D017403 In Situ Hybridization D013194 Staining and Labeling D016591 Histocytological Preparation Techniques D006652 Histological Techniques D009693 Nucleic Acid Hybridization