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CompletedNCT00897767Updated Jun 22, 2023

Collecting Tissue Samples From Patients With Leukemia or Other Blood Disorders Planning to Enroll in an ECOG Leukemia Treatment Clinical Trial

An observational study in Leukemia and Lymphoma, sponsored by Eastern Cooperative Oncology Group. Completed at 214 sites in United States. Open to participants aged 0 Years to 120 Years. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by Eastern Cooperative Oncology Group · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,873
Ages
0 Years to 120 Years
Sex
All
01

Study summary

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 determine a patient's eligibility for a treatment clinical trial. It may also help the study of cancer in the future.

PURPOSE: This laboratory study is collecting tissue samples from patients with leukemia or other blood disorders who are planning to enroll in an ECOG leukemia treatment clinical trial.

Read the detailed description

OBJECTIVES:

  • To provide a mechanism for sample collection and submission for diagnostic review to determine eligibility of patients with suspected leukemia or related hematologic disorders for enrollment on ECOG leukemia clinical trials.
  • To obtain baseline samples for correlative studies outlined in parent clinical trials.

OUTLINE: This is a cohort, multicenter study.

Patients submit bone marrow and/or blood samples. The samples are studied to determine patients' eligibility for ECOG leukemia treatment clinical trials. Samples may be stored for future correlative studies related to ECOG treatment clinical trials.

02

Conditions studied

  • Leukemia
  • Lymphoma

Keywords

  • accelerated phase chronic myelogenous leukemia
  • atypical chronic myeloid leukemia, BCR-ABL1 negative
  • blastic phase chronic myelogenous leukemia
  • childhood chronic myelogenous leukemia
  • chronic myelomonocytic leukemia
  • chronic phase chronic myelogenous leukemia
  • juvenile myelomonocytic leukemia
  • meningeal chronic myelogenous leukemia
  • progressive hairy cell leukemia, initial treatment
  • recurrent adult acute lymphoblastic leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult T-cell leukemia/lymphoma
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood acute myeloid leukemia
  • refractory chronic lymphocytic leukemia
  • refractory hairy cell leukemia
  • relapsing chronic myelogenous leukemia
  • stage I adult T-cell leukemia/lymphoma
  • stage I chronic lymphocytic leukemia
  • stage II adult T-cell leukemia/lymphoma
  • stage II chronic lymphocytic leukemia
  • stage III adult T-cell leukemia/lymphoma
  • stage III chronic lymphocytic leukemia
  • stage IV adult T-cell leukemia/lymphoma
  • stage IV chronic lymphocytic leukemia
  • untreated adult acute lymphoblastic leukemia
  • untreated adult acute myeloid leukemia
  • untreated childhood acute lymphoblastic leukemia
  • untreated childhood acute myeloid leukemia and other myeloid malignancies
  • T-cell large granular lymphocyte leukemia
  • 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)
  • secondary acute myeloid leukemia
  • childhood acute myeloid leukemia in remission
  • acute undifferentiated leukemia
  • mast cell leukemia
  • adult acute lymphoblastic leukemia in remission
  • childhood acute lymphoblastic leukemia in remission
  • prolymphocytic leukemia
  • untreated hairy cell leukemia
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 1,873 is above the median of 136 across 625 observational studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Eastern Cooperative Oncology Group is the lead sponsor of 173 studies on the registry; 7 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Potential candidates for ECOG-ACRIN Leukemia Trials

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Candidate for enrollment on an ECOG treatment clinical trial for acute or chronic leukemia

    • Suspected clinical diagnosis and protocol ID number of the treatment clinical trial under consideration must be submitted to ECOG's Leukemia Translational Studies Laboratory to ensure that the required antibody panels are used and functional assays are performed
  • Chosen ECOG treatment clinical trial must be active and accruing

    • Patient must not have begun treatment on the ECOG treatment clinical trial
  • Patient may be concurrently enrolled on this laboratory study and a treatment clinical trial if immediate treatment is medically necessary

    • If subsequent diagnostic review alters the original diagnosis, the patient will be removed from the treatment clinical trial

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,873 participants (actual)

Interventions

  • Otherbiologic sample preservation procedure
06

What researchers measure

Primary outcomes

  1. Providing a mechanism for sample collection and submission for diagnostic review to determine eligibility for enrollment on ECOG leukemia clinical trials

    Time frame: 6 month

  2. Obtaining baseline sample collection for correlative studies outlined in parent clinical trials

    Time frame: 6 month

07

Study locations

214 sites
  • UAB Comprehensive Cancer Center
    Birmingham, Alabama 35294, United States
  • Mayo Clinic Scottsdale
    Scottsdale, Arizona 85259-5499, United States
  • Aurora Presbyterian Hospital
    Aurora, Colorado 80012, United States
  • Boulder Community Hospital
    Boulder, Colorado 80301-9019, United States
  • Penrose Cancer Center at Penrose Hospital
    Colorado Springs, Colorado 80933, United States
  • St. Anthony Central Hospital
    Denver, Colorado 80204, United States
  • Porter Adventist Hospital
    Denver, Colorado 80210, United States
  • Presbyterian - St. Luke's Medical Center
    Denver, Colorado 80218, United States
  • St. Joseph Hospital
    Denver, Colorado 80218, United States
  • Rose Medical Center
    Denver, Colorado 80220, United States
  • CCOP - Colorado Cancer Research Program
    Denver, Colorado 80222, United States
  • Swedish Medical Center
    Englewood, Colorado 80110, United States
  • Poudre Valley Hospital
    Fort Collins, Colorado 80524, United States
  • Front Range Cancer Specialists
    Fort Collins, Colorado 80528, United States
  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
    Grand Junction, Colorado 81502, United States
  • North Colorado Medical Center
    Greeley, Colorado 80631, United States
  • Littleton Adventist Hospital
    Littleton, Colorado 80122, United States
  • Sky Ridge Medical Center
    Lone Tree, Colorado 80124, United States
  • Hope Cancer Care Center at Longmont United Hospital
    Longmont, Colorado 80501, United States
  • McKee Medical Center
    Loveland, Colorado 80539, United States
  • Parker Adventist Hospital
    Parker, Colorado 80138, United States
  • St. Mary - Corwin Regional Medical Center
    Pueblo, Colorado 81004, United States
  • North Suburban Medical Center
    Thornton, Colorado 80229, United States
  • Exempla Lutheran Medical Center
    Wheat Ridge, Colorado 80033, United States
  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
    Hartford, Connecticut 06105, United States
  • Tunnell Cancer Center at Beebe Medical Center
    Lewes, Delaware 19958, United States
  • CCOP - Christiana Care Health Services
    Newark, Delaware 19713, United States
  • Baptist Cancer Institute - Jacksonville
    Jacksonville, Florida 32207, United States
  • Mayo Clinic - Jacksonville
    Jacksonville, Florida 32224, United States
  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
    Boise, Idaho 83706, United States
  • Rush-Copley Cancer Care Center
    Aurora, Illinois 60504, United States
  • St. Joseph Medical Center
    Bloomington, Illinois 61701, United States
  • Graham Hospital
    Canton, Illinois 61520, United States
  • Memorial Hospital
    Carthage, Illinois 62321, United States
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
    Chicago, Illinois 60611-3013, United States
  • Hematology and Oncology Associates
    Chicago, Illinois 60611, United States
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • Decatur Memorial Hospital Cancer Care Institute
    Decatur, Illinois 62526, United States
  • Eureka Community Hospital
    Eureka, Illinois 61530, United States
  • Evanston Hospital
    Evanston, Illinois 60201-1781, United States
  • Galesburg Clinic, PC
    Galesburg, Illinois 61401, United States
  • Kellogg Cancer Care Center
    Highland Park, Illinois 60035, United States
  • Provena St. Mary's Regional Cancer Center - Kankakee
    Kankakee, Illinois 60901, United States
  • North Shore Oncology and Hematology Associates, Limited - Libertyville
    Libertyville, Illinois 60048, United States
  • McDonough District Hospital
    Macomb, Illinois 61455, United States
  • Cancer Care and Hematology Specialists of Chicagoland - Niles
    Niles, Illinois 60714, United States
  • BroMenn Regional Medical Center
    Normal, Illinois 61761, United States
  • Community Cancer Center
    Normal, Illinois 61761, United States
  • Community Hospital of Ottawa
    Ottawa, Illinois 61350, United States
  • Cancer Treatment Center at Pekin Hospital
    Pekin, Illinois 61554, United States
  • Proctor Hospital
    Peoria, Illinois 61614, United States
  • CCOP - Illinois Oncology Research Association
    Peoria, Illinois 61615, United States
  • Oncology Hematology Associates of Central Illinois, PC - Peoria
    Peoria, Illinois 61615, United States
  • Methodist Medical Center of Illinois
    Peoria, Illinois 61636, United States
  • OSF St. Francis Medical Center
    Peoria, Illinois 61637, United States
  • Illinois Valley Community Hospital
    Peru, Illinois 61354, United States
  • Swedish-American Regional Cancer Center
    Rockford, Illinois 61104-2315, United States
  • Hematology Oncology Associates - Skokie
    Skokie, Illinois 60076, United States
  • Regional Cancer Center at Memorial Medical Center
    Springfield, Illinois 62781-0001, United States
  • CCOP - Carle Cancer Center
    Urbana, Illinois 61801, United States
  • Saint Anthony Memorial Health Centers
    Michigan City, Indiana 46360, United States
  • McFarland Clinic, PC
    Ames, Iowa 50010, United States
  • CCOP - Iowa Oncology Research Association
    Des Moines, Iowa 50309, United States
  • John Stoddard Cancer Center at Iowa Methodist Medical Center
    Des Moines, Iowa 50309, United States
  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
    Des Moines, Iowa 50309, United States
  • Medical Oncology and Hematology Associates at Mercy Cancer Center
    Des Moines, Iowa 50314, United States
  • Mercy Cancer Center at Mercy Medical Center - Des Moines
    Des Moines, Iowa 50314, United States
  • John Stoddard Cancer Center at Iowa Lutheran Hospital
    Des Moines, Iowa 50316, United States
  • Siouxland Hematology-Oncology Associates, LLP
    Sioux City, Iowa 51101, United States
  • Mercy Medical Center - Sioux City
    Sioux City, Iowa 51102, United States
  • St. Luke's Regional Medical Center
    Sioux City, Iowa 51104, United States
  • Cancer Center of Kansas, PA - Chanute
    Chanute, Kansas 66720, United States
  • Cancer Center of Kansas, PA - Dodge City
    Dodge City, Kansas 67801, United States
  • Cancer Center of Kansas, PA - El Dorado
    El Dorado, Kansas 67042, United States
  • Cancer Center of Kansas - Fort Scott
    Fort Scott, Kansas 66701, United States
  • Cancer Center of Kansas-Independence
    Independence, Kansas 67301, United States
  • Cancer Center of Kansas, PA - Kingman
    Kingman, Kansas 67068, United States
  • Lawrence Memorial Hospital
    Lawrence, Kansas 66044, United States
  • Cancer Center of Kansas, PA - Liberal
    Liberal, Kansas 67901, United States
  • Cancer Center of Kansas, PA - McPherson
    McPherson, Kansas 67460, United States
  • Cancer Center of Kansas, PA - Newton
    Newton, Kansas 67114, United States
  • Cancer Center of Kansas, PA - Parsons
    Parsons, Kansas 67357, United States
  • Cancer Center of Kansas, PA - Pratt
    Pratt, Kansas 67124, United States
  • Cancer Center of Kansas, PA - Salina
    Salina, Kansas 67401, United States
  • Cancer Center of Kansas, PA - Wellington
    Wellington, Kansas 67152, United States
  • Associates in Womens Health, PA - North Review
    Wichita, Kansas 67208, United States
  • Cancer Center of Kansas, PA - Medical Arts Tower
    Wichita, Kansas 67208, United States
  • Cancer Center of Kansas, PA - Wichita
    Wichita, Kansas 67214, United States
  • CCOP - Wichita
    Wichita, Kansas 67214, United States
  • Via Christi Cancer Center at Via Christi Regional Medical Center
    Wichita, Kansas 67214, United States
  • Wesley Medical Center
    Wichita, Kansas 67214, United States
  • Cancer Center of Kansas, PA - Winfield
    Winfield, Kansas 67156, United States
  • York Hospital's Oncology Treatment Center
    York, Maine 03909, United States
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Baltimore, Maryland 21231-2410, United States
  • Union Hospital of Cecil County
    Elkton, Maryland 21921, United States
  • Tufts Medical Center Cancer Center
    Boston, Massachusetts 02111, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Baystate Regional Cancer Program at D'Amour Center for Cancer Care
    Springfield, Massachusetts 01199, United States
  • Hickman Cancer Center at Bixby Medical Center
    Adrian, Michigan 49221, United States
  • Saint Joseph Mercy Cancer Center
    Ann Arbor, Michigan 48106-0995, United States

Showing the first 100 of 214 sites.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00897767
Lead sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
May 12, 2009
Start date
Sep 21, 2004
Primary completion
Aug 21, 2014
Completion
Dec 21, 2014
Last update
Jun 22, 2023

Study contacts

Elisabeth Paietta, PhD
study chair · Our Lady of Mercy Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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