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S9007, Study of Bone Marrow and Blood Samples From Patients With Leukemia or Other Hematopoietic Cancers

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00996047
First received: October 15, 2009
Last updated: January 2, 2013
Last verified: January 2013
History of Changes

October 15, 2009
January 2, 2013
July 1991
January 2012   (final data collection date for primary outcome measure)
Maintain and expand a database of cytogenetic information on leukemia patients. [ Time Frame: While protocol was open ] [ Designated as safety issue: No ]
Frequencies and prognostic significance of cytogenetic abnormalities at various timepoints (generally prestudy, remission, and relapse at minimum) depending on the treatment protocol [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00996047 on ClinicalTrials.gov Archive Site
Not Provided
  • Correlation of cytogenetic features with clinical, pathophysiological, cellular, or molecular characteristics after study analysis [ Designated as safety issue: No ]
  • Frequency of trisomy 12 in patients with chronic lymphocytic leukemia (CLL) by fluorescence in situ hybridization (FISH) and conventional cytogenetics [ Designated as safety issue: No ]
  • Feasibility of FISH as a clinical diagnostic technique in patients with CLL [ Designated as safety issue: No ]
  • Quality control for all Southwest Oncology Group cytogenetic data [ Designated as safety issue: No ]
Not Provided
Not Provided
 
S9007, Study of Bone Marrow and Blood Samples From Patients With Leukemia or Other Hematopoietic Cancers
S9007, Cytogenetic Studies in Leukemia Patients

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.
Observational
Not Provided
Not Provided
Retention:   None Retained
Description:

Blood and bone marrow
Non-Probability Sample

Patients registered to SWOG leukemia treatment protocols
  • Leukemia
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Genetic: cytogenetic analysis
  • Genetic: fluorescence in situ hybridization
Not Provided
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3341
January 2012
January 2012   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Registered on one of the following Southwest Oncology Group treatment protocols:

    • SWOG-8326, SWOG-8600, SWOG-8612, SWOG-9034, SWOG-9108, OR any new leukemia protocol approved as of 1990

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00996047
CDR0000078651, SWOG-9007, U10CA032102
No
Southwest Oncology Group
Southwest Oncology Group
  • National Cancer Institute (NCI)
  • Eastern Cooperative Oncology Group
Study Chair: Elisabeth Paietta, PhD Our Lady of Mercy Medical Center Comprehensive Cancer Center
Southwest Oncology Group
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP