## Protocol Section
### Identification Module
**NCT ID:** NCT01016379

**Brief Title:** Studying DNA in Blood and Bone Marrow Samples From Young Patients With Acute Lymphoblastic Leukemia

**Official Title:** Genome-Wide Interrogations in Childhood Acute Lymphoblastic Leukemia (ALL)

#### Organization Study ID Info
**ID:** AALL08B2
#### Organization
**Class:** NETWORK
**Full Name:** Children's Oncology Group
#### Secondary ID Infos
**ID:** COG-AALL08B2
**ID:** CDR0000659101
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2011-02200
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2016-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-05-17

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-05-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-05

**Type:** ACTUAL

#### Start Date
**Date:** 2009-11

**Status Verified Date:** 2016-05

#### Study First Post Date
**Date:** 2009-11-19
**Type:** ESTIMATED
**Study First Submit Date:** 2009-11-18
**Study First Submit QC Date:** 2009-11-18
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** NETWORK

**Name:** Children's Oncology Group

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

**Detailed Description:** 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.

### Conditions Module

**Conditions:**

- Leukemia

**Keywords:**

- untreated childhood acute lymphoblastic leukemia

- recurrent childhood acute lymphoblastic leukemia

### Design Module

#### Bio Spec

**Description:** Blood and Bone Marrow

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 1000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** DNA analysis

**Type:** GENETIC

#### Intervention 2

**Name:** biologic sample preservation procedure

**Type:** OTHER

#### Intervention 3

**Name:** laboratory biomarker analysis

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Determination of genome-wide genotypes

**Measure:** Mechanism for storing, distributing, and tracking usage of blast and germline genomic information

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

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

### Eligibility Module

**Eligibility 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

**Maximum Age:** 30 Years

**Minimum Age:** 1 Year

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

**Study Population:** Young Patients With Acute Lymphoblastic Leukemia

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** University of California, San Francisco

**Name:** Mignon Loh, MD

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10945

- Name: Leukemia

- Relevance: HIGH

- As Found: Leukemia

- ID: M10951

- Name: Leukemia, Lymphoid

- Relevance: HIGH

- As Found: Lymphoblastic Leukemia

- ID: M27585

- Name: Precursor Cell Lymphoblastic Leukemia-Lymphoma

- Relevance: HIGH

- As Found: Acute Lymphoblastic Leukemia

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M11220

- Name: Lymphoma

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T175

- Name: Acute Lymphoblastic Leukemia

- Relevance: HIGH

- As Found: Acute Lymphoblastic Leukemia

- ID: T3533

- Name: Lymphoblastic Lymphoma

- Relevance: HIGH

- As Found: Acute Lymphoblastic Leukemia

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T1134

- Name: Childhood Acute Lymphoblastic Leukemia

- Relevance: HIGH

- As Found: Childhood acute lymphoblastic leukemia

- ID: T3543

- Name: Lymphosarcoma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007938

- Term: Leukemia

- ID: D000054198

- Term: Precursor Cell Lymphoblastic Leukemia-Lymphoma

- ID: D000007945

- Term: Leukemia, Lymphoid

### Misc Info Module

- Version Holder: 2024-05-24
