Identification of de Novo Fanconi Anemia in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia

Sponsor

Children's Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT01146210

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This research study is studying identification of de novo Fanconi anemia in younger patients with newly diagnosed acute myeloid leukemia. Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to Fanconi anemia in patients with acute myeloid leukemia.

Condition or Disease	Intervention/Treatment	Phase
Childhood Acute Erythroleukemia (M6) Childhood Acute Megakaryocytic Leukemia (M7) Childhood Acute Minimally Differentiated Myeloid Leukemia (M0) Childhood Acute Monoblastic Leukemia (M5a) Childhood Acute Monocytic Leukemia (M5b) Childhood Acute Myeloblastic Leukemia With Maturation (M2) Childhood Acute Myeloblastic Leukemia Without Maturation (M1) Childhood Acute Myelomonocytic Leukemia (M4) Childhood Myelodysplastic Syndromes Chronic Myelomonocytic Leukemia de Novo Myelodysplastic Syndromes Fanconi Anemia Refractory Anemia Refractory Anemia With Excess Blasts Refractory Anemia With Excess Blasts in Transformation Refractory Anemia With Ringed Sideroblasts Secondary Myelodysplastic Syndromes Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies	Other: laboratory biomarker analysis

Detailed Description

PRIMARY OBJECTIVES:

Identify children with newly diagnosed acute myeloid leukemia (AML) treated on COG-2961 and COG-AAML03P1 who are at high risk of having de novo Fanconi anemia.
Procure diagnostic samples from the COG AML Biology Repository and identify Fanconi anemia patients using western blot techniques.

OUTLINE:

Previously collected cryopreserved cells are analyzed via western blot to identify patients with Fanconi anemia.

Study Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Identification of de Novo Fanconi Anemia Patients Using FANCD2 Western Blots

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Ancillary-correlative Previously collected cryopreserved cells are analyzed via western blot to identify patients with Fanconi anemia.	Other: laboratory biomarker analysis Correlative studies

Arm

Intervention/Treatment

Ancillary-correlative

Previously collected cryopreserved cells are analyzed via western blot to identify patients with Fanconi anemia.

Other: laboratory biomarker analysis

Correlative studies

Outcome Measures

Primary Outcome Measures

Identification of children at high risk of having Fanconi anemia [Up to 5 months]
Identification of Fanconi anemia patients [Up to 5 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Treated on COG-2961 or COG-AAML03P1
At high risk of having Fanconi anemia, defined as meeting one the following groups of clinical criteria:
Group 1: Prolonged neutropenia after induction, severe regimen-related toxicity (mucositis, veno-occlusive disease, end-organ damage)
Group 2: Early non-relapse death (induction, consolidation)
Group 3: Small-for-weight, secondary malignancies