Text Size

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

This study is currently recruiting participants.
Verified December 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00897767
First received: May 9, 2009
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  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 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.


Condition Intervention
Leukemia
Lymphoma
 Other: biologic sample preservation procedure

Study Type: Observational
Official Title: Ancillary Laboratory Protocol For the Collection of Diagnostic Material On Patients Considered For ECOG Treatment Trials For Leukemia Or Related Hematologic Disorders

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Providing a mechanism for sample collection and submission for diagnostic review to determine eligibility for enrollment on ECOG leukemia clinical trials [ Designated as safety issue: No ]
  • Obtaining baseline sample collection for correlative studies outlined in parent clinical trials [ Designated as safety issue: No ]

Study Start Date: July 2004
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897767

  Show 214 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Elisabeth Paietta, PhD Our Lady of Mercy Medical Center Comprehensive Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00897767     History of Changes
Other Study ID Numbers: CDR0000357586, ECOG-E3903
Study First Received: May 9, 2009
Last Updated: December 5, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Leukemia
Lymphoma
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013