Evidence map›Paper›PMID 41116168›Full record

Observational studyBMC cancer2025

A multicenter observational cohort study in survivors of Down Syndrome-associated acute leukemia (ALTE22C1): a report from the Children's Oncology Group.

M Monica Gramatges, Lauren N Sanclemente, Lacey Hall, Olga A Taylor, Michelle M Nuño, Smita Bhatia, Eric J Chow, Kelly D Getz, Johann K Hitzler, Amanda M Li and 11 more

Registry-linked trialAbstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05702645 (Chronic Health Conditions in Down Syndrome-Associated Acute Leukemia), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05702645 recruitingnot on this map

Chronic Health Conditions in Down Syndrome-Associated Acute Leukemia: The Down Syndrome Phenotyping Acute Leukemia Study in Survivors (DS-PALS Survivors)

TypeobservationalSponsorChildren's Oncology GroupRan2023 to 2029Enrolled330ConditionsB Acute Lymphoblastic Leukemia Associated With Down Syndrome, Down Syndrome, Myeloid Leukemia Associated With Down SyndromeArmsBiospecimen Collection, Clinical Evaluation, Neurocognitive Assessment, Questionnaire Administration, Survey Administration
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

M Monica GramatgesTexas Children's Hospital, Baylor College of Medicine, 6620 Main St., Ste 1530, Houston, TX, 77030, USA. gramatge@bcm.edu.
Lauren N SanclementeTexas Children's Hospital, Baylor College of Medicine, 6620 Main St., Ste 1530, Houston, TX, 77030, USA.
Lacey HallSt. Jude Children's Research Hospital, Memphis, TN, USA.
Olga A TaylorEmory University, Atlanta, GA, USA.
Michelle M NuñoChildren's Oncology Group, Monrovia, CA, University of Southern California, Los Angeles, CA, USA.
Smita BhatiaUniversity of Alabama at Birmingham, Birmingham, AL, USA.
Eric J ChowFred Hutchinson Cancer Center, Seattle Children's Hospital, University of Washington, Seattle, WA, USA.
Kelly D GetzUniversity of Pennsylvania, Philadelphia, PA, USA.
Johann K HitzlerThe Hospital for Sick Children, Toronto, ON, Canada.
Amanda M LiBC Children's Hospital, University of British Columbia, Vancouver, BC, Canada.
Kaitlin McCloskeyUniversity of Michigan, Ann Arbor, MI, USA.
Paul C NathanThe Hospital for Sick Children, Toronto, ON, Canada.
Maureen M O'BrienChildren's Hospital Colorado, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Serina PatelChildren's Hospital, London Health Sciences Centre, London, ON, Canada.
Anupam VermaPediatric Specialists of Virginia, Fairfax, VA, USA.
Angela R YarbroughThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Melissa A RichardTexas Children's Hospital, Baylor College of Medicine, 6620 Main St., Ste 1530, Houston, TX, 77030, USA.
Tracie C RosserEmory University, Atlanta, GA, USA.
Lisa M JacolaSt. Jude Children's Research Hospital, Memphis, TN, USA.
Philip J LupoTexas Children's Hospital, Baylor College of Medicine, 6620 Main St., Ste 1530, Houston, TX, 77030, USA.
Karen R RabinTexas Children's Hospital, Baylor College of Medicine, 6620 Main St., Ste 1530, Houston, TX, 77030, USA.

Funding

NCTN BIQSFP ANBL1531 (NRT)U10CA180886 · NCI · PUBLIC HEALTH INSTITUTE · PI Douglas S. Hawkins · 2014 to 2026
$390.6M
COG SDMC - Statistics CoreU10CA180899 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI TODD A ALONZO · 2014 to 2026
$132.8M
Towards a preventive cancer vaccine for children with constitutional mismatch repair deficiencyUG1CA189955 · NCI · PUBLIC HEALTH INSTITUTE · PI BRAD H POLLOCK, Michael E. Roth · 2014 to 2026
$62.5M
Molecular epidemiology of acute lymphoblastic leukemia in children with Down syndromeR01CA249867 · NCI · BAYLOR COLLEGE OF MEDICINE · PI LUPO, PHILIP, RABIN, KAREN R · 2020 to 2024
$4.2M
Chronic Health Conditions in Survivors of Down Syndrome-Associated LeukemiaR01CA263000 · NCI · BAYLOR COLLEGE OF MEDICINE · PI Maria Monica Gramatges, Lisa M Jacola · 2022 to 2026
$3.1M
Enriching medical phenotypes and environmental traits in the large DS360 Down syndrome cohortR03HD108261 · NICHD · EMORY UNIVERSITY · PI ROSSER, TRACIE C · 2022 to 2022
$313k
Eunice Kennedy Shriver National Institute of Child Health and Human Development R03HD108261NCI NIH HHS R01 CA249867NCI NIH HHS R01 CA263000NCI NIH HHS R01CA263000NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899NCI NIH HHS UG1 CA189955NICHD NIH HHS R03 HD108261
6 · The paper itself

Abstract

backgroundDown syndrome (DS) is a common genetic disorder resulting from an extra copy of genetic material from all or part of chromosome 21. Individuals with DS have a higher burden of co-occurring structural birth defects, neurocognitive delay, and chronic health conditions when compared to those without DS, as well as a 10 to 20-fold excess risk for acute leukemia (AL). Few studies have reported the late effects of cancer treatment in DS-AL survivors, and even fewer have compared outcomes to children with DS and no cancer history. The Children’s Oncology Group study ALTE22C1 was developed to address this knowledge gap.

methodsThis study leverages both registry and site-based DS-AL survivor recruitment and a prospective/retrospective cohort design to compare chronic health conditions and neurocognitive outcomes experienced by DS-AL survivors to age and sex-matched individuals enrolled to a DS cohort for which cancer is exclusionary. Survivors 6–39 years old, ≥ 3 years from end of AL treatment, and in remission are eligible. Participants complete a medical conditions survey and neuropsychological battery by parent proxy and may also participate in an in-person physical and neurocognitive assessment. Biological samples are collected to evaluate molecular features associated with outcomes. DISCUSSION: This cooperative group study will identify the prevalence and severity of medical and neurocognitive outcomes in DS-AL survivors compared with non-DS AL and DS controls without cancer history. Results are anticipated to inform clinical practice guidelines for DS-AL survivors and improve survivor outcomes through mitigation of outcome disparities in this vulnerable population.

trial registrationChildren’s Oncology Group study ALTE22C1 is registered under the ClinicalTrials.gov identifier NCT05702645.

Indexed as

Cancer SurvivorsDown SyndromeAdolescentAdultChildFemaleHumansMaleProspective StudiesRetrospective StudiesYoung AdultCancer survivorshipChildhood leukemiaDown syndrome

Identifiers

PMID41116168
PMCPMC12538926

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.