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Clinical trialNCT07560826RecruitingPhase 2Interventional

The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma

SponsorWake Forest University Health SciencesEnrollment46Osteosarcoma in Adolescents and Young AdultsOsteosarcoma in Children
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The goal of this study is to learn whether children, adolescents, and young adults with newly diagnosed high-grade osteosarcoma can be safely discharged from the hospital at slightly higher methotrexate blood levels after receiving standard high-dose methotrexate chemotherapy. Participants are 22 years old or younger and are receiving standard MAP (high-dose methotrexate with doxorubicin and cisplatin) chemotherapy as part of their routine cancer treatment. The main questions this study aims to answer are: * Is hospital discharge at higher methotrexate levels safe, based on side effects or hospital re-admission within 7 days? * Can patient-derived osteosarcoma tumor organoids be successfully generated across multiple centers? Researchers will compare safety outcomes and hospital length of stay to historical patient data discharged at lower methotrexate levels. Participants will receive standard chemotherapy, meet study-defined discharge criteria, be monitored for side effects, and have the option to provide tumor and blood samples for future research.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Thomas Russell, MD

    Alliance for Research and Innovations in Pediatric Oncology (ARISE) Cancer Consortium

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

9 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, United States

    Ian Davis, MD, PhD
    Not, yet, recruiting
  • Atrium Health Levine Children'S Hospital

    Charlotte, North Carolina, United States

    Thomas Russell, MD
    Recruiting
  • Novant Health Hemby Children'S Hospital

    Charlotte, North Carolina, United States

    Jessica Bell, MD
    Not, yet, recruiting
  • Duke University Medical Center

    Durham, North Carolina, United States

    Jessica Sun, MD
    Not, yet, recruiting
  • East Carolina University

    Greenville, North Carolina, United States

    Andrea Whitfield, DO
    Not, yet, recruiting
  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina, United States

    Sarah Supples, MD
    Recruiting
  • Medical University of South Carolina

    Charleston, South Carolina, United States

    Jacqueline Kraveka, DO
    Not, yet, recruiting
  • Prisma Health Midlands

    Columbia, South Carolina, United States

    Chandni Dargan, MD
    Not, yet, recruiting
  • Prisma Health Upstate

    Greenville, South Carolina, United States

    Chandni Dargan, MD
    Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

High-dose Methotrexate
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Sept 2026
Primary completion
31 Dec 2028
Completion
31 Dec 2028
Last update posted
13 Oct 2026
Registered enrollment
46
Registry id
NCT07560826

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.