What this study is
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.
What's being tested
- Questionnaire
Intervention · OTHER
PROMIS questionnaire
Study details
- Official title
- Functional Outcomes in Patients Who Undergo Upfront Surgical Resection for High-Grade Osteosarcoma of the Extremity: A Pilot Study
- Sponsor
- Montefiore Medical Center
- Conditions
- Osteosarcoma
- Enrolling
- 10 people
- Starts
- 2024-03-25
- Est. completion
- 2028-12
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 5 Years – 40 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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)
You can't join if
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMontefiore Medical Center
The Bronx, New York, United States
- Rebecca Zylber · Contact718-741-2356rzylber@montefiore.org
- Alice Lee, M.D. · Principal investigator
- David Geller, M.D. · Sub-investigator
Recruiting
Study team
Sponsor
Montefiore Medical Center
Study ID 2023-14741
Principal investigator
Alice Lee, M.D.
Montefiore Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.