Completed OBSERVATIONAL NCT01146210

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

Identification of de Novo Fanconi Anemia Patients Using FANCD2 Western Blots

Sponsor: Children's Oncology Group

Conditions 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 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 de Novo Myelodysplastic Syndromes

Interventions laboratory biomarker analysis

Updated 11 times since 2017 Last updated: May 13, 2016 Started: May 31, 2009 Primary completion: May 31, 2016 Completion: May 31, 2016

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Childhood Acute Erythroleukemia (M6) and Childhood Acute Megakaryocytic Leukemia (M7) and is currently completed. Children's Oncology Group leads this study, which shows 11 recorded versions since 2009 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

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.

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.

Status Flow

Change History

11 versions recorded

Jan 2026 — Present [monthly]

Completed
Sep 2024 — Present [monthly]

Completed
Jul 2024 — Sep 2024 [monthly]

Completed
Dec 2021 — Jul 2024 [monthly]

Completed
Jan 2021 — Dec 2021 [monthly]

Completed

▶ Show 6 earlier versions

Nov 2020 — Jan 2021 [monthly]

Completed
Jun 2018 — Nov 2020 [monthly]

Completed
May 2018 — Jun 2018 [monthly]

Completed
Apr 2018 — May 2018 [monthly]

Completed

Phase: NA → None
Aug 2017 — Apr 2018 [monthly]

Completed NA
Jan 2017 — Aug 2017 [monthly]

Completed NA

First recorded

May 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Children's Oncology Group
National Cancer Institute (NCI)

Data source: Children's Oncology Group

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Monrovia, United States