NCT06384404 Upfront Surgical Resection for Osteosarcoma
| NCT ID | NCT06384404 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Montefiore Medical Center |
| Condition | Osteosarcoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-03-25 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10 participants in total. It began in 2024-03-25 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this pilot study is to learn about patients with newly diagnosed osteosarcoma of an extremity, and whether surgically removing the tumor prior to the administration of any chemotherapy will improve functional outcomes. In order to learn about the patient's experience, the study team will administer questionnaires to the patient and surgeon at various timepoints to assess recovery and the function of the extremity.
Eligibility Criteria
Inclusion Criteria: * Patients must have newly diagnosed, previously untreated, localized, high-grade osteosarcoma of an extremity (verified by histopathology) with plans to undergo upfront surgical resection of the tumor followed by systemic chemotherapy. * Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2 (Karnofsky will be used for patients \>16 years of age and Lansky score for patients \<= 16 years of age) Exclusion Criteria: * Patients with metastatic disease at diagnosis * Initiation of systemic therapy prior to enrollment * Prior history of cancer * Prior radiation therapy * Active life-threatening infection * Pregnancy (negative pregnancy test result must be obtained for female patients of childbearing potential)
Contact & Investigator
Alice Lee, M.D.
PRINCIPAL INVESTIGATOR
Montefiore Medical Center
Frequently Asked Questions
Who can join the NCT06384404 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 40 Years, studying Osteosarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06384404 currently recruiting?
Yes, NCT06384404 is actively recruiting participants. Contact the research team at rzylber@montefiore.org for enrollment information.
Where is the NCT06384404 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT06384404 clinical trial?
NCT06384404 is sponsored by Montefiore Medical Center. The principal investigator is Alice Lee, M.D. at Montefiore Medical Center. The trial plans to enroll 10 participants.