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NCT07560826 · ClinicalTrials.gov registry record · Phase 2
The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma
A Phase 2 study, sponsored by Wake Forest University Health Sciences.
- Not yet
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT07560826 is a Phase 2 study that has not yet begun recruiting, run by Wake Forest University Health Sciences. The registered enrollment target is 46 participants.
The verdict
NCT07560826, a Phase 2 study, has not yet begun recruiting, sponsored by Wake Forest University Health Sciences.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG High-dose Methotrexate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2026-08 |
| Est. Completion | 2028-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07560826
The ClinicalTrials.gov registry entry for NCT07560826 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which High-dose Methotrexate is the first listed.
NCT07560826 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07560826 about?
NCT07560826 is a clinical study titled "The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma". 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 ye...
What is the current status of trial NCT07560826?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2026-08. Estimated completion is 2028-12.
What interventions are being tested in trial NCT07560826?
The interventions under investigation include: High-dose Methotrexate (DRUG).
Who is sponsoring clinical trial NCT07560826?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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