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S9910, Collecting and Storing Blood and Bone Marrow Samples From Patients With Hematologic Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00919425
First received: June 11, 2009
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

RATIONALE: Collecting and storing samples of blood and bone marrow from patients with cancer to study in the laboratory may help doctors learn more about diagnosing cancer and how well patients will respond to treatment.

PURPOSE: The purpose of this study is to collect and store blood and bone marrow samples from patients with hematologic cancer to be tested in the laboratory.


Condition Intervention
Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Other: biologic sample preservation procedure

Study Type: Observational
Official Title: S9910, Leukemia Centralized Reference Laboratories and Tissue Repositories - Ancillary

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Maintenance and expansion of tissue repositories of highly characterized samples from patients with ALL, CLL, AML, CML, or myelodysplastic syndromes [ Time Frame: While protocol was open ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood and bone marrow


Enrollment: 1294
Study Start Date: April 1999
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Primary objective:

  • Maintain and expand tissue repositories of highly characterized samples from patients with acute lymphoblastic leukemia, chronic lymphocytic leukemia, acute myeloid leukemia, chronic myelogenous leukemia, or myelodysplastic syndromes.

Other objectives as funding permits:

  • Develop laboratory assays for rapid and precise diagnosis of leukemia using bone marrow and peripheral blood samples.
  • Determine biologic, genetic, and molecular parameters that distinguish different subtypes of human leukemia with differing responses to therapy, and develop "risk-adapted" therapeutic approaches based on these parameters to tailor therapeutic regimens, randomize or stratify patients in clinical trials, or otherwise assist in therapeutic decision-making.
  • Develop new automated and standardized laboratory methods for the detection and monitoring of therapeutic responsiveness and minimal residual disease in patients and use this information to design clinical trials.

OUTLINE: Patients receive treatment as directed by the Southwest Oncology Group (SWOG) study to which they are registered.

Patients undergo collection of peripheral blood (myeloid leukemia) or venous blood (lymphoid leukemia) and bone marrow at baseline, at the time of response or remission, and at the time of progression or relapse. Additional collections may take place according to the guidelines of the study in which the patient is registered.

Specimens are stored for use in laboratory research.

PROJECTED ACCRUAL: Samples from a maximum of 1,000 patients will be collected for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients participating on SWOG leukemia treatment studies

Criteria

DISEASE CHARACTERISTICS:

  • Currently registered on a Southwest Oncology Group (SWOG) treatment study for acute lymphoblastic leukemia, chronic lymphocytic leukemia, acute myeloid leukemia, chronic myelogenous leukemia, or myelodysplastic syndromes

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919425

  Show 292 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Cheryl L. Willman, MD MBCCOP - University of New Mexico HSC
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00919425     History of Changes
Other Study ID Numbers: CDR0000078601, S9910, U10CA032102
Study First Received: June 11, 2009
Last Updated: January 2, 2013
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
stage 0 chronic lymphocytic leukemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid leukemia
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute lymphoblastic leukemia in remission
childhood acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
childhood acute myeloid leukemia in remission
recurrent childhood acute myeloid leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies
recurrent childhood acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia
childhood chronic myelogenous leukemia
de novo myelodysplastic syndromes

Additional relevant MeSH terms:
Leukemia
Myelodysplastic Syndromes
Myelodysplastic-Myeloproliferative Diseases
Myeloproliferative Disorders
Neoplasms
Preleukemia
Syndrome
Bone Marrow Diseases
Disease
Hematologic Diseases
Neoplasms by Histologic Type
Pathologic Processes
Precancerous Conditions

ClinicalTrials.gov processed this record on November 25, 2014