Acute Myeloid Leukemia Clinical Trial

Backtracking Leukemia-Typical Somatic Mutations in Cord Blood

Summary

A comprehensive mechanistic and epidemiological study to obtain banked cord blood samples from consecutive childhood leukemia patients enrolled in the COG Project:EveryChild (APEC14B1) study. Will attempt to backtrack the initiating genomic alteration identified in the matched diagnostic leukemia sample and molecularly characterize pre-leukemic cells. The ultimate goal of this research is to pinpoint the cell of origin of leukemogenic alterations formed in utero, elucidating the etiology of these initiating mutations (as opposed to frank leukemia), and devising a test for circulating pre-leukemia that can be applied on a population-wide basis.

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Full Description

OBJECTIVES:

Primary Aim 1: To obtain stored cord blood and dried bloodspots of pediatric leukemia patients in Project:EveryChild.

Secondary Aim 2: To conduct preliminary backtracking and characterization of ALL- and AML-typical somatic mutations in cord blood and dried bloodspots.

OUTLINE:

Accrue patients with ALL and AML who indicate having banked cord blood at birth through the APEC14B1 intake questionnaire

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Eligibility Criteria

Inclusion Criteria:

The patient must have a diagnosis of acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
Stored diagnostic pre-treatment samples corresponding to the patient's original diagnosis of leukemia must be available for request from either the COG Biopathology Center or a treating institution
The patient must be enrolled on APEC14B1 with consent to future contact and indicate that cord blood was stored at birth in the APEC14B1 registry intake data.
The patient must also have been registered with COG by a North American (limited to the U.S. and Canada) member institution.
≤ 25 years old at the time of original diagnosis with ALL or AML
The patient must be able to understand written and spoken English or Spanish
All patients must provide their consent/assent, as appropriate, and for patients under the age of majority at least one parent or legal guardian must provide consent as well
All institutional, FDA, and NCI requirements for human studies must be met

Exclusion Criteria:

Patients who responded that cord blood was not stored at birth are excluded. Patients without stored diagnostic, pre-treatment leukemia samples at either the COG Biopathology Center or their treating institution are excluded.

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

300

Study ID:

NCT05014165

Recruitment Status:

Recruiting

Sponsor:

Children's Oncology Group

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There is 1 Location for this study

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University of Minnesota/Masonic Cancer Center
Minneapolis Minnesota, 55455, United States More Info
Logan Spector, PhD
Contact
612-624-3912
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

300

Study ID:

NCT05014165

Recruitment Status:

Recruiting

Sponsor:


Children's Oncology Group

How clear is this clinincal trial information?

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