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CompletedNCT01146210Updated May 17, 2016

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

An observational study in Childhood Acute Erythroleukemia (M6), Childhood Acute Megakaryocytic Leukemia (M7) and Childhood Acute Minimally Differentiated Myeloid Leukemia (M0), sponsored by Children's Oncology Group. Completed at 1 site in United States. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2016-05-17.

Sponsored by Children's Oncology Group · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
20
Ages
Up to 21 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • 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
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 20 is below the median of 120 across 744 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients treated on trials COG-2961 or COG-AAML03P1. Also patients at high risk of having Fanconi anemia meeting other criteria.

Eligibility criteria

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
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
20 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Ancillary-correlative

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

    Other: laboratory biomarker analysis

Interventions

  • Otherlaboratory biomarker analysis

    Correlative studies

06

What researchers measure

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

07

Study locations

1 site
  • Children's Oncology Group
    Monrovia, California 91006-3776, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01146210
Lead sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jun 17, 2010
Start date
May 2009
Primary completion
May 2016
Completion
May 2016
Last update
May 17, 2016

Study contacts

Monica Thakar, MD
principal investigator · Children's Oncology Group

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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