Brief 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.
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.
Brief Title
Collecting Tissue Samples From Patients With Leukemia or Other Blood Disorders Planning to Enroll in an ECOG Leukemia Treatment Clinical Trial
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.
* 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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Leukemia
Lymphoma
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
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
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
120 Years
Minimum Age
0 Years
NCT Id
NCT00897767
Org Class
Network
Org Full Name
Eastern Cooperative Oncology Group
Org Study Id
CDR0000357586
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Ancillary Laboratory Protocol For the Collection of Diagnostic Material On Patients Considered For ECOG Treatment Trials For Leukemia Or Related Hematologic Disorders
Primary Outcomes
Outcome Measure
Providing a mechanism for sample collection and submission for diagnostic review to determine eligibility for enrollment on ECOG leukemia clinical trials
Outcome Time Frame
6 month
Outcome Measure
Obtaining baseline sample collection for correlative studies outlined in parent clinical trials
Outcome Time Frame
6 month
Secondary Ids
Secondary Id
ECOG-E3903
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Potential candidates for ECOG-ACRIN Leukemia Trials
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
120
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Joseph Sparano
Investigator Email
jsparano@montefiore.org
Investigator Phone
718-405-8404
Categories Mesh Debug
Cancer --- LEUKEMIA
Blood & Bone Marrow Cancers --- LEUKEMIA
Blood & Bone Marrow Cancers --- LEUKEMIA, MYELOMONOCYTIC, JUVENILE
Blood & Bone Marrow Cancers --- PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA
Blood & Bone Marrow Cancers --- LEUKEMIA, MYELOID, ACUTE
Blood & Bone Marrow Cancers --- LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL
Blood & Bone Marrow Cancers --- CONGENITAL ABNORMALITIES
Cancer --- NEOPLASMS
Blood Disorders --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- LYMPHOPROLIFERATIVE DISORDERS
Blood & Bone Marrow Cancers --- LYMPHATIC DISEASES
Blood & Bone Marrow Cancers --- IMMUNOPROLIFERATIVE DISORDERS
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
Blood & Bone Marrow Cancers --- LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE
Blood & Bone Marrow Cancers --- LEUKEMIA, MYELOID
Blood & Bone Marrow Cancers --- MYELOPROLIFERATIVE DISORDERS
Blood & Bone Marrow Cancers --- BONE MARROW DISEASES
Blood & Bone Marrow Cancers --- MYELODYSPLASTIC-MYELOPROLIFERATIVE DISEASES
Blood & Bone Marrow Cancers --- LEUKEMIA, LYMPHOID
MeSH Terms
LEUKEMIA
LYMPHOMA
LEUKEMIA, MYELOID, ACCELERATED PHASE
LEUKEMIA, MYELOID, CHRONIC, ATYPICAL, BCR-ABL NEGATIVE
BLAST CRISIS
LEUKEMIA, MYELOMONOCYTIC, CHRONIC
LEUKEMIA, MYELOID, CHRONIC-PHASE
LEUKEMIA, MYELOMONOCYTIC, JUVENILE
PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA
LEUKEMIA, MYELOID, ACUTE
PRECURSOR T-CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA
LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL
LEUKEMIA, HAIRY CELL
LEUKEMIA, LARGE GRANULAR LYMPHOCYTIC
CONGENITAL ABNORMALITIES
LEUKEMIA, BIPHENOTYPIC, ACUTE
LEUKEMIA, MAST-CELL
LEUKEMIA, PROLYMPHOCYTIC
NEOPLASMS BY HISTOLOGIC TYPE
NEOPLASMS
HEMATOLOGIC DISEASES
HEMIC AND LYMPHATIC DISEASES
LYMPHOPROLIFERATIVE DISORDERS
LYMPHATIC DISEASES
IMMUNOPROLIFERATIVE DISORDERS
IMMUNE SYSTEM DISEASES
LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE
LEUKEMIA, MYELOID
MYELOPROLIFERATIVE DISORDERS
BONE MARROW DISEASES
CHRONIC DISEASE
DISEASE ATTRIBUTES
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
MYELODYSPLASTIC-MYELOPROLIFERATIVE DISEASES
CELL TRANSFORMATION, NEOPLASTIC
CARCINOGENESIS
NEOPLASTIC PROCESSES
LEUKEMIA, LYMPHOID
LEUKEMIA, B-CELL
LEUKEMIA, T-CELL
CONGENITAL, HEREDITARY, AND NEONATAL DISEASES AND ABNORMALITIES
MASTOCYTOSIS, SYSTEMIC
MASTOCYTOSIS
MAST CELL ACTIVATION DISORDERS