NCT07502885 Deep Phenotyping Gait Deficits in Orthopedic Manifestations of Pediatric Cancer Patients
| NCT ID | NCT07502885 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Jude Children's Research Hospital |
| Condition | Sarcoma, Bone |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-06-16 |
| Primary Completion | 2031-01 |
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 300 participants in total. It began in 2026-06-16 with a primary completion date of 2031-01.
⚠ 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 DEEPGAIT study is to determine how serious walking problems are for pediatric cancer patients who have had orthopedic surgery, how they change over time, and what can be done to help. Healthy participants without cancer will also be included in this study in order to better understand the difference in walking problems between the 2 groups. DEEPGAIT is a long term study that uses advanced tools-including 3D motion capture, muscle sensors, force plates, and wearable devices-to take a detailed look at how these patients move. Their results are compared to healthy children of the same age and sex. PRIMARY OBJECTIVES * Characterize gait deficits in pediatric cancer patients 1 year following orthopedic surgery for lower limb bone sarcoma, soft tissue sarcoma, or steroid-induced avascular necrosis. * Identify personal, disease, treatment and environment risk factors for gait deficits in pediatric cancer patients 1 year following orthopedic surgery for lower limb bone sarcoma, soft tissue sarcoma, or steroid-induced avascular necrosis. SECONDARY OBJECTIVES * Build a library of broadly representative normative reference values to generate age- and sex-matched z-scores to quantify frequency, severity and progression of gait deficits among pediatric cancer patients in relation to healthy controls. * Characterize the changes of gait parameters in pediatric cancer patients with or without gait deficits 1 year after orthopedic surgery for lower limb bone sarcoma, soft tissue sarcoma, or steroid-induced avascular necrosis, up to 5 years after surgery. * Identify personal, disease, treatment and environment risk factors for trajectories of gait deficits in pediatric cancer patients with or without gait deficits 1 year after orthopedic surgery for lower limb bone sarcoma, soft tissue sarcoma, or steroid-induced avascular necrosis, up to 5 years after surgery.
Eligibility Criteria
Inclusion Criteria Cases: * Participant requiring orthopedic surgery due to a diagnosis of lower limb bone sarcoma, soft tissue sarcoma, or steroid-induced avascular necrosis (Appendix III) and will receive further additional treatment and/or follow-up care at St. Jude. * Participant is between the ages of ≥5 and ≤20 years old at the time of enrollment. Controls: * Participant is between the ages of ≥5 and ≤20 years old at the time of enrollment. * Participant (or their parent/legal guardian) considers themself healthy for their age. * Participant (or their parent/legal guardian) reports being able to participate in normal daily activities of life with respect to their age. Exclusion Criteria Cases: * Individuals with pre-existing genetic/congenital disorders affecting gait will be excluded e.g., cerebral palsy. * Individuals who are unable to follow age-appropriate instructions during the gait assessment. * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent. * Individuals diagnosed with radiation-induced avascular necrosis. Controls: * Individuals who are unable to follow age-appropriate instructions during the gait assessment. * Individuals who self-report health conditions affecting gait and mobility. * Individuals who have the following conditions: diabetes mellitus due to impaired circulation, sensation and strength, malignant cancers, demyelinating inflammatory and degenerative neurological conditions, pregnancy, obesity (BMI \>40 kg/m2), severe cardiac or pulmonary disease affecting performance of daily activities, history of major surgery affecting gait and mobility, infections or inflammatory arthropathies, severe mobility impairment necessitating dependence on mobility aids for all ambulation. * Individual or legal guardian/representative is unable or unwilling to give written informed consent.
Contact & Investigator
Joshua Burns, PhD
PRINCIPAL INVESTIGATOR
St. Jude Children's Research Hospital
Frequently Asked Questions
Who can join the NCT07502885 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 20 Years, studying Sarcoma, Bone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07502885 currently recruiting?
Yes, NCT07502885 is actively recruiting participants. Contact the research team at referralinfo@stjude.org for enrollment information.
Where is the NCT07502885 trial being conducted?
This trial is being conducted at Memphis, United States.
Who is sponsoring the NCT07502885 clinical trial?
NCT07502885 is sponsored by St. Jude Children's Research Hospital. The principal investigator is Joshua Burns, PhD at St. Jude Children's Research Hospital. The trial plans to enroll 300 participants.