The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma (NCT07560826)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of North Carolina at Chapel Hill — Chapel Hill, North Carolina
Age range: 7 Years to 22 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (8 Sites)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina
- Novant Health Hemby Children's Hospital — Charlotte, North Carolina
- Duke University Medical Center — Durham, North Carolina
- East Carolina University — Greenville, North Carolina
- Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina
- Medical University of South Carolina — Charleston, South Carolina
- Prisma Health Midlands — Columbia, South Carolina
- Prisma Health Upstate — Greenville, South Carolina
📞 Contact the Study Coordinator
Phone: (980) 442-2303
Email: heather.neagle@advocatehealth.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Osteosarcoma in Children clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.