Montefiore Medical Center
The Bronx, New York, 10467, United States
Location status: Recruiting
Location contact
Alice Lee, M.D.
PRINCIPAL_INVESTIGATOR
David Geller, M.D.
SUB_INVESTIGATOR
Rebecca Zylber
CONTACT
NCT Number: NCT06384404
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.
Interested in participating?
Request Info5 year–40 year
All sexes
Observational
The Bronx, New York, 10467, United States
Location status: Recruiting
Alice Lee, M.D.
PRINCIPAL_INVESTIGATOR
David Geller, M.D.
SUB_INVESTIGATOR
Rebecca Zylber
CONTACT
This prospective, non-randomized pilot study will assess patient-reported functional outcomes of upfront surgical resection in patients with newly diagnosed, biopsy-proven, localized osteosarcoma of the extremity or the pelvis. Following biopsy, all patients will undergo wide excision of the tumor followed by systemic multi-agent cytotoxic chemotherapy consisting of a regimen at least equivalent to the standard of care of high dose Methotrexate, Doxorubicin, and Cisplatin (MAP). Patients and/or their parent/guardian will be administered PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaires, while surgeons will be administered the Musculoskeletal Tumor Society (MSTS) questionnaire at various timepoints through the first year post-surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PROMIS questionnaire
Time frame: approximately 1 year
Modified age-based PROMIS measures will be used to assess HRQoL changes (PROMIS 25 Parent Proxy will be used for ages 5-7; PROMIS 25 for 8-17; PROMIS 29+2 for 18+)
PROMIS 25 (and PROMIS 25 Parent Proxy) contain six, 4-item short forms for domains: physical function mobility, anxiety, depressive symptoms, fatigue, peer relationships, pain interference; along with a pain intensity item. Scores for each domain range from 1-5 (pain intensity 0-10). Responses to individual items are coded to values and summed to generate a total raw score. Total raw scores are converted/rescaled into a standardized T-score for each participant with a mean of 50 and a standard deviation (SD) of 10. Higher PROMIS T-scores represent more of the concept being measured
PROMIS 29+2 is similar to PROMIS 25 with the exception of a social roles/activities domain in place of peer relationships, and also includes sleep disturbance and cognitive function domains. Scores are determined as described for PROMIS 25
Time frame: Up to 2 years
The number of participants with event-free survival (EFS) will be determined. Event-free survival will be defined as the time from diagnosis until disease progression, recurrence at any site, secondary malignancy, death, or last follow-up, whichever is observed first
Contact information is provided by the study sponsor or research team.
Montefiore Medical Center
Other
Functional Outcomes in Patients Who Undergo Upfront Surgical Resection for High-Grade Osteosarcoma of the Extremity: A Pilot Study
Acronym: UFSR for OS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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