Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT04248959
Eligibility Criteria:
Inclusion Criteria:
* ≥18 years and \<40 years of age at diagnosis
* Fluent in English
* Able to comply with study and follow-up procedures contained within the consent form
* Pathologically or radiologically confirmed diagnosis of a soft-tissue or osteosarcoma of the upper or lower extremities
* Soft-tissue or osteosarcoma must be considered operable
* Patients of all weight bearing states will be eligible
* Expected LOS ≥ 5 days as calculated by the validated American College of Surgeons Surgical Risk Calculator
* \>14 days between time of randomization and time of expected surgery
* Patient written, informed consent obtained according to ICH GCP guidelines and local regulations
* Medical clearance to participate in the study from either the primary treating surgeon (JW, PF) or oncologist (AG)
Exclusion Criteria:
* Planned resection of bony pelvis or major lower extremity neurovascular structures
* Significant comorbidity including any of the following:
* Canadian Cardiovascular Society class III/IV coronary disease
* New York Heart Association class III/IV congestive heart failure
* Neurologic or musculoskeletal disorder prohibiting exercise
* Major neuropsychiatric disorder
* High-risk or presence of pathological fracture
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
39 Years
Study:
NCT04248959
Study Brief:
Protocol Section:
NCT04248959