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Genome-Wide Interrogations in Childhood Acute Lymphoblastic Leukemia (ALL)


N/A
1 Year
30 Years
Open (Enrolling)
Both
Leukemia

Thank you

Trial Information

Genome-Wide Interrogations in Childhood Acute Lymphoblastic Leukemia (ALL)


OBJECTIVES:

- To manage and oversee determination of genome-wide genotypes using common laboratory
methodologies for young patients with newly diagnosed acute lymphoblastic leukemia
(ALL).

- To provide a mechanism for storing, distributing, and tracking usage of blast and
germline genomic information for approved projects.

- To facilitate research for childhood ALL using genome-wide germline and blast data to
identify genetic variations associated with important phenotypes: treatment response
(e.g., relapse risk, minimal residual disease status), adverse effects (e.g.,
osteonecrosis, infection risk, neurotoxicity), risk of ALL, and risk of ALL subtypes
(e.g., TEL/AML1, BCR/ABL, T-cell).

- To provide a data resource, that can be linked with additional tumor cell information,
to better characterize the biology and subtypes of childhood ALL.

OUTLINE: This is a multicenter study.

DNA from previously collected and banked blood and bone marrow samples is utilized for
genome-wide genotyping.

Genotype data is only used to examine specific questions related to the epidemiology and
etiology of leukemia, response of leukemia to treatment, risk of recurrence, risk for
development of side effects, and complications related to treatment.

Inclusion Criteria


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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Determination of genome-wide genotypes

Safety Issue:

No

Principal Investigator

Mignon Loh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Federal Government

Study ID:

CDR0000659101

NCT ID:

NCT01016379

Start Date:

November 2009

Completion Date:

Related Keywords:

  • Leukemia
  • untreated childhood acute lymphoblastic leukemia
  • recurrent childhood acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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