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Backtracking Leukemia-Typical Somatic Mutations in Cord Blood

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
Up to 25 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "OUTLINE: Accrue patients with ALL and AML who indicate having banked cord blood at birth through the APEC14B1 intake questionnaire"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at stored blood from the umbilical cord to find gene changes linked to leukemia that began before birth. It is for people diagnosed with certain types of leukemia at age 25 or younger who joined COG Project:EveryChild. The goal is to understand how these changes start and help develop a blood test to find cells that may later become leukemia.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML), two types of blood cancer.
  • Have stored leukemia samples from the original diagnosis, taken before treatment, available from the COG Biopathology Center or treating hospital.
  • Be enrolled in COG Project:EveryChild (APEC14B1), have agreed to future contact, and have a study record saying cord blood was stored at birth.
  • Have been registered with COG by a member hospital or center in the U.S. or Canada.
  • Have been age 25 or younger when first diagnosed with ALL or AML.
  • Be able to understand written and spoken English or Spanish.
  • Agree to take part as required for your age. Those under the legal adult age also need permission from at least one parent or legal guardian.
  • Meet all hospital, FDA, and National Cancer Institute rules for studies involving people.

Who can't join

  • Reported that cord blood was not stored at birth.
  • Do not have stored leukemia samples from the original diagnosis, taken before treatment, at the COG Biopathology Center or treating hospital.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (1)

MN