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Collecting and Storing Blood, Bone Marrow, and Other Samples From Patients With Acute Leukemia, Chronic Leukemia, or Myelodysplastic Syndromes

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ClinicalTrials.gov Identifier: NCT00899223
Recruitment Status : Active, not recruiting
First Posted : May 12, 2009
Last Update Posted : July 20, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
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Brief Summary:
As one of the nation's largest cooperative cancer treatment groups, the Alliance for Clinical Trials in Oncology (Alliance) is in a unique position to organize a Leukemia Tissue Bank. The member institutions diagnose hundreds of patients with leukemia or myelodysplastic syndrome each year, and uniformly treat these patients with chemotherapy regimens. The Alliance offers centralized data management for the clinical history, the classification of the leukemia and myelodysplastic syndrome, cytogenetics, flow cytometric analysis, treatment and follow-up. The highly skilled health care providers at each member institution are familiar with obtaining informed consent, completing data questionnaires and shipping specimens. There currently exists a central processing facility where samples are prepared for a variety of cellular and molecular studies. Hence, the patient resources, the health care providers, and a processing facility for a Leukemia Tissue Bank are all in place. What is needed, however, and is addressed in the current protocol, is a formal mechanism to procure bone marrow, blood and normal tissue from patients with hematologic malignancies who are to be enrolled on Alliance (Cancer and Leukemia Group B [CALGB]) treatment studies.

Condition or disease Intervention/treatment
Acute Leukemia Chronic Leukemia Myelodysplasia Other: biologic sample preservation procedure

Detailed Description:

The objective of the study is to collect and store specimens from every newly diagnosed patient with acute or chronic leukemia or myelodysplastic syndrome (MDS) who are entered on a CALGB protocol for previously untreated patients. Bone marrow aspirate and blood specimens are obtained from patients at diagnosis, remission, or relapse and stored. Buccal smears are obtained at diagnosis, and DNA is extracted and preserved.

It was anticipated that the specimens collected under this protocol would be used by a large number of investigators. This protocol does not describe the details of each approved project (eg, eligibility age range).

Study Design
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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The CALGB Leukemia Tissue Bank
Actual Study Start Date : May 1996
Estimated Primary Completion Date : December 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Group 1
Previously untreated patients on a CALGB treatment protocol for leukemia (acute or chronic) or myelodysplasia are eligible. Patients must be registered to CALGB 9665 prior to receiving any therapy for their disease.
 Other: biologic sample preservation procedure


Outcome Measures
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Primary Outcome Measures :
  1. Collection and storage of specimens from newly diagnosed patients with acute or chronic leukemia or myelodysplastic syndromes enrolled on a CALGB protocol [ Time Frame: At diagnosis ]
  2. Collection and storage of specimens from newly diagnosed patients with acute or chronic leukemia or myelodysplastic syndromes enrolled on a CALGB protocol [ Time Frame: At relapse ]
  3. Collection and storage of specimens from newly diagnosed patients with acute or chronic leukemia or myelodysplastic syndromes enrolled on a CALGB protocol [ Time Frame: At remission ]

Biospecimen Retention:   Samples With DNA
  • Bone Marrow Aspirate: 5 mL of bone marrow aspirate at the time of diagnosis, relapse, and during remission for each CALGB leukemia or myelodysplastic syndrome treatment protocol.
  • Blood: 10 mL of whole blood at the time of diagnosis, relapse, and during remission for each CALGB leukemia or myelodysplastic syndrome treatment protocol.
  • Buccal Cell Sample: One buccal cell sample at time of diagnosis, but may be obtained at other times if not done so previously

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with leukemia or myelodysplasia.
Criteria
  • Previously untreated patients on a CALGB treatment protocol for leukemia (acute or chronic) or myelodysplasia are eligible. Patients must be registered to CALGB 9665 prior to receiving any therapy for their disease.
  • Signed informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899223


Locations
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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Michael Caligiuri, MD Ohio State University Comprehensive Cancer Center
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00899223    
Other Study ID Numbers: CALGB-9665
U10CA031946 ( U.S. NIH Grant/Contract )
CALGB-9665
CDR0000271412 ( Registry Identifier: NCI Physician Data Query )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: July 2021
Additional relevant MeSH terms:
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Leukemia
Preleukemia
Myelodysplastic Syndromes
Neoplasms by Histologic Type
 Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions