Studying DNA in Blood and Bone Marrow Samples From Young Patients With Acute Lymphoblastic Leukemia

NCT01016379 | Completed

• 4 other identifiers: AALL08B2COG-AALL08B2CDR0000659101NCI-2011-02200
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment. PURPOSE: This research study is looking at DNA in blood and bone marrow samples from young patients with acute lymphoblastic leukemia.

Conditions

Leukemia

Keywords

untreated childhood acute lymphoblastic leukemia; recurrent childhood acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (4)

• Determination of genome-wide genotypes

• Mechanism for storing, distributing, and tracking usage of blast and germline genomic information

• Identification of genetic variations associated with important phenotypes (treatment response, adverse effects, risk of acute lymphoblastic leukemia [ALL], and risk of ALL subtypes)

• Data resource, that can be linked with additional tumor cell information, to better characterize the biology and subtypes of childhood ALL

Interventions

DNA analysis GENETIC

biologic sample preservation procedure OTHER

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 1 Year - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Young Patients With Acute Lymphoblastic Leukemia

DISEASE CHARACTERISTICS: * Diagnosis of acute lymphoblastic leukemia (ALL) * Previously enrolled in COG-9900, COG-C1991, COG-AALL03B1, COG-AALL05B1, COG-AALL08P1, or other current COG or legacy trials for ALL AND consented to submit blood and marrow samples for biological research studies * Meets ≥ 1 of the following criteria: * Germline DNA that has been extracted from blood (preferentially) or bone marrow (if no appropriate blood available) that was collected on or after Day 28 of remission indication therapy, or is known to come from a sample that contained \< 10% leukemic blasts * ALL blast DNA that has been extracted from bone marrow (preferentially) or blood (if from a sample that contained \> 90% leukemic blasts and no diagnostic bone marrow is available) that was collected at the time of ALL diagnosis PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Blood and Bone Marrow

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Mignon Loh, MD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 19, 2009
• Study Start: November 1, 2009
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 17, 2016

Record last verified: 2016-05