Recent Trends in Clinical Trials for Pediatric Sarcoma in the United States: An Analysis of ClinicalTrials.gov.
Highlights: What are the main findings? Most sarcoma clinical trials enrolling children in the United States include both pediatric and adult patients rather than being pediatric-specific. Pediatric sarcoma trials are predominantly early-phase studies focused on drug or biologic therapies and are la...
| Publicado en: | Children Vol. 13; no. 4; pp. 455 - 470 |
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| Autores principales: | , , , , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
MDPI
Apr2026
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=193454285&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 193454285 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 22279067 LW6K jtl: Children issn: 22279067 maglogo: N pubinfo: dt: Apr2026 vid: 13 iid: 4 pid: 97109 pub: MDPI artinfo: ui: 193454285 193454285 193454285 10.3390/children13040455 193454285 ppf: 455 ppct: 15 formats: tig: atl: Recent Trends in Clinical Trials for Pediatric Sarcoma in the United States: An Analysis of ClinicalTrials.gov. aug: au: Alkhawaldeh, Khaled Thorpe, Signe Cho, Sukjoo Miller, Alexandra Alleyne, Maua Jones, Jennifer Beaupin, Lynda Gupta, Ajay Metts, Jonathan affil: Sarcoma Department, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA sug: subj: Clinical Trials Trends Sarcoma In Infancy and Childhood Research Subjects Patient Participation Human United States Female Male Child Adolescence Eligibility Determination Research Support Statistical Significance T-Tests Chi Square Test Fisher's Exact Test Wilcoxon Rank Sum Test Mann-Whitney U Test Kendall's tau Data Analysis Software Descriptive Statistics Funding Source Child: 6-12 years Adolescent: 13-18 years Female Male ab: Highlights: What are the main findings? Most sarcoma clinical trials enrolling children in the United States include both pediatric and adult patients rather than being pediatric-specific. Pediatric sarcoma trials are predominantly early-phase studies focused on drug or biologic therapies and are largely conducted across multiple institutions. What are the implications of the main findings? Limited pediatric-only trials may restrict age-specific insights into treatment efficacy and toxicity for children with sarcoma. Expanded pediatric-focused trial designs and improved accrual strategies are needed to advance outcomes in this underserved population. Background/Objectives: Pediatric sarcomas are rare and heterogeneous malignancies for which clinical trials are essential to advance treatment and improve outcomes. However, the characteristics and trends of sarcoma clinical trials enrolling children in the United States have not been comprehensively described. This study aimed to characterize U.S.-based sarcoma clinical trials enrolling pediatric patients and to evaluate trends over time. Methods: ClinicalTrials.gov was searched for interventional sarcoma trials conducted in the United States that enrolled patients ≤ 17 years of age and were posted between 27 September 2007 and 11 January 2023. Trials were categorized as pediatric (maximum eligible age ≤ 21 years) or pediatric/adult (>21 years). Trial characteristics, including phase, intervention type, funding source, geographic scope, and reasons for early termination, were analyzed. Results: A total of 273 eligible trials were identified, of which 79% enrolled both pediatric and adult patients. Most studies were early phase (Phase 1, 2, or 1/2; 59%) and primarily evaluated drug or biologic therapies (73%). Trials involving mixed cancer types were most common (26%). The majority were multi-institutional (66%), non-industry funded (57%) and conducted exclusively in the United States (75%). Trial activations increased over time (p-value = 0.01), with a higher proportion of industry-funded studies initiated between 2016 and 2022 (p-value = 0.009). Twenty-three trials (8.4%) were terminated early, most commonly due to slow accrual (39%). Conclusions: Most sarcoma clinical trials enrolling pediatric patients continue to include both adult and pediatric populations, which may limit the development of therapies tailored to the unique biology of pediatric sarcomas. Improving outcomes will require greater emphasis on pediatric-focused research, enhanced collaboration across institutions, and increased awareness of clinical and regulatory frameworks to support the initiation of industry-funded trials. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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