Investigating genetic changes in cord blood from childhood leukemia patients
Backtracking Leukemia-Typical Somatic Mutations in Cord Blood
Children's Oncology Group · NCT05014165
This study is trying to understand the genetic changes in cord blood from children with leukemia to see if it can help find early signs of the disease before it develops.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | N/A to 25 Years |
| Sex | All |
| Sponsor | Children's Oncology Group (network) |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05014165 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect and analyze banked cord blood samples from children diagnosed with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML). The research focuses on backtracking the genomic alterations present in these patients to identify the origins of leukemogenic mutations that may have occurred in utero. By characterizing pre-leukemic cells, the study seeks to develop a population-wide test for detecting circulating pre-leukemia. The study involves patient recruitment through the COG Project:EveryChild and requires stored diagnostic samples for analysis.
Who should consider this trial
Good fit: Ideal candidates include pediatric patients diagnosed with ALL or AML who have stored cord blood and are enrolled in the COG Project:EveryChild.
Not a fit: Patients who do not have stored cord blood or are not enrolled in the COG Project:EveryChild may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to early detection methods for pre-leukemia, potentially improving outcomes for children at risk of developing leukemia.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding the genetic basis of leukemia, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Study coordinator: Adam de Smith, PhD
- Email: adesmith@coh.org
- Phone: (626) 218-4913
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia