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NCT Number: NCT01146210

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

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.

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Key information

Conditions

Childhood Acute Erythroleukemia (M6) Anemia Anemia, Aplastic Anemia, Hypoplastic, Congenital Anemia, Refractory Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases Bone Marrow Failure Disorders 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 Disease Chronic Myelomonocytic Leukemia Congenital Bone Marrow Failure Syndromes Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Repair-Deficiency Disorders Disease Attributes Fanconi Anemia Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myelomonocytic, Chronic Metabolic Diseases Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Neoplasms Neoplasms by Histologic Type Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms 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 de Novo Myelodysplastic Syndromes

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Oncology Group

Monrovia, California, 91006-3776, United States

About this study

PRIMARY OBJECTIVES:

I. 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.

II. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Identification of children at high risk of having Fanconi anemia

    Time frame: Up to 5 months

  2. Identification of Fanconi anemia patients

    Time frame: Up to 5 months

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Identification of de Novo Fanconi Anemia Patients Using FANCD2 Western Blots

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Jun 17, 2010
Registry last updated
May 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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