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NCT00899223 Clinical Trial

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

Acute Leukemia Clinical Trial

Official title:
The CALGB Leukemia Tissue Bank

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00899223
Other study ID # CALGB-9665
Secondary ID U10CA031946CALGB
Status Active, not recruiting
Phase
First received
Last updated
Start date May 1996

Study information
Verified date August 2023
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1500
Est. completion date
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• biologic sample preservation procedure

Locations
Country Name City State
United States Mission Hospitals - Memorial Campus Asheville North Carolina
United States Harold Alfond Center for Cancer Care Augusta Maine
United States Greenebaum Cancer Center at University of Maryland Medical Center Baltimore Maryland
United States CancerCare of Maine at Eastern Maine Medical Center Bangor Maine
United States Mountainview Medical Berlin Vermont
United States National Naval Medical Center Bethesda Maryland
United States Hematology Oncology Associates of the Quad Cities Bettendorf Iowa
United States Illinois CancerCare - Bloomington Bloomington Illinois
United States St. Joseph Medical Center Bloomington Illinois
United States Dana-Farber/Brigham and Women's Cancer Center Boston Massachusetts
United States Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Roswell Park Cancer Institute Buffalo New York
United States Fletcher Allen Health Care - University Health Center Campus Burlington Vermont
United States Illinois CancerCare - Canton Canton Illinois
United States Southeast Cancer Center Cape Girardeau Missouri
United States Iowa Blood and Cancer Care Cedar Rapids Iowa
United States Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill North Carolina
United States Blumenthal Cancer Center at Carolinas Medical Center Charlotte North Carolina
United States Presbyterian Cancer Center at Presbyterian Hospital Charlotte North Carolina
United States University of Chicago Cancer Research Center Chicago Illinois
United States University of Illinois Cancer Center Chicago Illinois
United States Veterans Affairs Medical Center - Chicago Westside Hospital Chicago Illinois
United States Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia Missouri
United States Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Batte Cancer Center at Northeast Medical Center Concord North Carolina
United States New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Concord New Hampshire
United States Danville Regional Medical Center Danville Virginia
United States St. Luke's Hospital Cancer Care Center Duluth Minnesota
United States Duke Cancer Institute Durham North Carolina
United States CCOP - Hematology-Oncology Associates of Central New York East Syracuse New York
United States Elkhart Clinic, LLC Elkhart Indiana
United States Elkhart General Hospital Elkhart Indiana
United States Michiana Hematology-Oncology, PC - Elkhart Elkhart Indiana
United States Union Hospital of Cecil County Elkton Maryland
United States Eureka Community Hospital Eureka Illinois
United States Illinois CancerCare - Eureka Eureka Illinois
United States Evanston Hospital Evanston Illinois
United States McLeod Regional Medical Center Florence South Carolina
United States Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Fort Lauderdale Florida
United States Galesburg Clinic, PC Galesburg Illinois
United States Charles R. Wood Cancer Center at Glens Falls Hospital Glens Falls New York
United States Addison Gilbert Hospital Gloucester Massachusetts
United States Wayne Memorial Hospital, Incorporated Goldsboro North Carolina
United States Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center Grand Island Nebraska
United States Cancer Centers of the Carolinas - Eastside Greenville South Carolina
United States Cancer Centers of the Carolinas - Faris Road Greenville South Carolina
United States Cancer Centers of the Carolinas - Grove Commons Greenville South Carolina
United States CCOP - Greenville Greenville South Carolina
United States Greenville Hospital Cancer Center Greenville South Carolina
United States Leo W. Jenkins Cancer Center at ECU Medical School Greenville North Carolina
United States Cancer Centers of the Carolinas - Greer Medical Oncology Greer South Carolina
United States Helen and Harry Gray Cancer Center at Hartford Hospital Hartford Connecticut
United States Pardee Memorial Hospital Hendersonville North Carolina
United States New Hampshire Oncology - Hematology, PA - Hooksett Hooksett New Hampshire
United States Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa
United States Veterans Affairs Medical Center - Iowa City Iowa City Iowa
United States Queens Cancer Center of Queens Hospital Jamaica New York
United States Goldschmidt Cancer Center Jefferson City Missouri
United States Ella Milbank Foshay Cancer Center at Jupiter Medical Center Jupiter Florida
United States Heartland Hematology Oncology Associates, Incorporated Kansas City Missouri
United States North Kansas City Hospital Kansas City Missouri
United States Research Medical Center Kansas City Missouri
United States Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City Missouri
United States Kinston Medical Specialists Kinston North Carolina
United States Howard Community Hospital Kokomo Indiana
United States Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte Indiana
United States Lakes Region General Hospital Laconia New Hampshire
United States Monter Cancer Center of the North Shore-LIJ Health System Lake Success New York
United States CCOP - Nevada Cancer Research Foundation Las Vegas Nevada
United States Sunrise Hospital and Medical Center Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Saint Luke's East - Lee's Summit Lee's Summit Missouri
United States Tunnell Cancer Center at Beebe Medical Center Lewes Delaware
United States Illinois CancerCare - Macomb Macomb Illinois
United States Norris Cotton Cancer Center at Catholic Medical Center Manchester New Hampshire
United States CCOP - North Shore University Hospital Manhasset New York
United States Don Monti Comprehensive Cancer Center at North Shore University Hospital Manhasset New York
United States Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County Martinsville Virginia
United States Suniti Medical Corporation Merrillville Indiana
United States CCOP - Mount Sinai Medical Center Miami Beach Florida
United States Masonic Cancer Center at University of Minnesota Minneapolis Minnesota
United States Veterans Affairs Medical Center - Minneapolis Minneapolis Minnesota
United States Michiana Hematology-Oncology, PC - South Bend Mishawaka Indiana
United States Saint Joseph Regional Medical Center Mishawaka Indiana
United States Camino Medical Group - Treatment Center Mountain View California
United States Long Island Jewish Medical Center New Hyde Park New York
United States Mount Sinai Medical Center New York New York
United States New York Weill Cornell Cancer Center at Cornell University New York New York
United States CCOP - Christiana Care Health Services Newark Delaware
United States BroMenn Regional Medical Center Normal Illinois
United States Community Cancer Center Normal Illinois
United States Illinois CancerCare - Community Cancer Center Normal Illinois
United States Cancer Care Associates - Norman Norman Oklahoma
United States Callahan Cancer Center at Great Plains Regional Medical Center North Platte Nebraska
United States Cancer Care Associates - Mercy Campus Oklahoma City Oklahoma
United States Oklahoma University Cancer Institute Oklahoma City Oklahoma
United States UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha Nebraska
United States Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando Florida
United States Community Hospital of Ottawa Ottawa Illinois
United States Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa Illinois
United States Menorah Medical Center Overland Park Kansas
United States Saint Luke's Hospital - South Overland Park Kansas
United States Cancer Treatment Center at Pekin Hospital Pekin Illinois
United States Illinois CancerCare - Pekin Pekin Illinois
United States CCOP - Illinois Oncology Research Association Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria Illinois
United States OSF St. Francis Medical Center Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois CancerCare - Peru Peru Illinois
United States Illinois Valley Community Hospital Peru Illinois
United States Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital Pittsburgh Pennsylvania
United States Michiana Hematology Oncology PC - Plymouth Plymouth Indiana
United States CCOP - Kansas City Prairie Village Kansas
United States Miriam Hospital Providence Rhode Island
United States Rhode Island Hospital Comprehensive Cancer Center Providence Rhode Island
United States Virginia Commonwealth University Massey Cancer Center Richmond Virginia
United States Lakeland Regional Cancer Care Center - St. Joseph Saint Joseph Michigan
United States Lakeside Cancer Specialists, PLLC Saint Joseph Michigan
United States Saint Joseph Oncology, Incorporated Saint Joseph Missouri
United States Missouri Baptist Cancer Center Saint Louis Missouri
United States Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Saint Louis Missouri
United States Naval Medical Center - San Diego San Diego California
United States UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California
United States Cancer Centers of the Carolinas - Seneca Seneca South Carolina
United States Cleveland Regional Medical Center Shelby North Carolina
United States CCOP - Northern Indiana CR Consortium South Bend Indiana
United States Memorial Hospital of South Bend South Bend Indiana
United States Cancer Centers of the Carolinas - Spartanburg Spartanburg South Carolina
United States Illinois CancerCare - Spring Valley Spring Valley Illinois
United States Iredell Memorial Hospital Statesville North Carolina
United States SUNY Upstate Medical University Hospital Syracuse New York
United States Veterans Affairs Medical Center - Syracuse Syracuse New York
United States Cancer Institute of New Jersey at Cooper - Voorhees Voorhees New Jersey
United States Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington District of Columbia
United States Washington Cancer Institute at Washington Hospital Center Washington District of Columbia
United States Michiana Hematology Oncology PC - La Porte Westville Indiana
United States Forsyth Regional Cancer Center at Forsyth Medical Center Winston-Salem North Carolina
United States Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Liu TH, Raval A, Chen SS, Matkovic JJ, Byrd JC, Plass C. CpG island methylation and expression of the secreted frizzled-related protein gene family in chronic lymphocytic leukemia. Cancer Res. 2006 Jan 15;66(2):653-8. doi: 10.1158/0008-5472.CAN-05-3712. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Collection and storage of specimens from newly diagnosed patients with acute or chronic leukemia or myelodysplastic syndromes enrolled on a CALGB protocol At diagnosis
Primary Collection and storage of specimens from newly diagnosed patients with acute or chronic leukemia or myelodysplastic syndromes enrolled on a CALGB protocol At relapse
Primary Collection and storage of specimens from newly diagnosed patients with acute or chronic leukemia or myelodysplastic syndromes enrolled on a CALGB protocol At remission
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