Study of Biomarkers in DNA Samples From Patients With Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

NCT ID: NCT01005277

Last Updated: 2022-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-04-17

Brief Summary

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This research study is looking at biomarkers in DNA samples from patients with acute lymphoblastic leukemia or acute myeloid leukemia. Studying samples of DNA from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

Detailed Description

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PRIMARY OBJECTIVES:

I. Collect DNA samples from patients with cytogenetically, well characterized, and uniformly treated acute lymphoblastic leukemia or acute myeloid leukemia for use in analysis of a wide range of host factors influencing etiology and outcome of the disease.

II. Identify host factors that can be determined at onset of treatment to predict outcome of chemotherapy, and thus modify the therapy administered.

OUTLINE:

Previously collected DNA samples are analyzed for polymorphisms at a variety of loci. Gene expression and expression profiles are correlated with genotype and therapy outcomes.

Conditions

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Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1 Adult Acute Promyelocytic Leukemia With PML-RARA Childhood Acute Lymphoblastic Leukemia in Remission Childhood Acute Myeloid Leukemia Childhood Acute Myeloid Leukemia in Remission Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Acute Myeloid Leukemia Secondary Acute Myeloid Leukemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Ancillary-Correlative (genetic polymorphisms)

Previously collected DNA samples are analyzed for polymorphisms at a variety of loci. Gene expression and expression profiles are correlated with genotype and therapy outcomes.

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Interventions

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Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* DNA samples available from patients meeting the following criteria:

* Infants with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML)
* Patients with pre-B ALL, including responders vs non-responders in selected genotypes \[hyperdiploid, hypodiploid, t(12;21), t(9;22), t(1;19), and t(4;11)\] and responders and non-responders regardless of genotype
* Pediatric patients with AML registered on POG-9421
* Adult patients with ALL, including t(8.21), inv(16), t(15;17), complex cytogenetics, and secondary AML
* Pediatric patients with relapsed ALL enrolled on COG-AALL01P2
* Pediatric patients enrolled on COG-9900 and other CCG or POG trials
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Children's Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stella Davies

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

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Childrens Oncology Group

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2009-00325

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000271322

Identifier Type: -

Identifier Source: secondary_id

COG-ABTR02B1

Identifier Type: -

Identifier Source: secondary_id

ABTR02B1

Identifier Type: -

Identifier Source: secondary_id

ABTR02B1

Identifier Type: OTHER

Identifier Source: secondary_id

ABTR02B1

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA098543

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ABTR02B1

Identifier Type: -

Identifier Source: org_study_id

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