Actively Recruiting
Digital Biomarker and Omics-Based Assessment of Surgical Resiliency in Children Undergoing Solid Tumor Resection: A Pilot Feasibility Study
Led by Mayo Clinic · Updated on 2026-01-26
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how children and their families recover after major cancer surgery. This observational study aims to understand recovery patterns and resilience by using data from patients and caregivers. The study also looks at specific protein and metabolite patterns linked to surgery-related stress. It focuses on children and young adults with extracranial solid tumors undergoing surgery. Participants will wear smartwatches to collect activity, heart rate, and sleep data starting before surgery and continuing for one year after. They will complete questionnaires about their quality of life and mood at multiple timepoints before and after surgery. Extra blood samples may be taken during routine clinical blood draws for research analysis. Clinical data such as diagnosis, treatment, and surgery outcomes will also be collected. Participants and their caregivers will be asked to wear the smartwatch continuously except during certain activities. Questionnaires can be done electronically, by phone, or in person at scheduled intervals up to one year post-surgery. Researchers will evaluate surgical resilience over one year using wearable data, questionnaires, blood biomarkers, and clinical information. There are no changes to clinical care, and participants will receive compensation for their time.
CONDITIONS
Brief Title
Biomarkers of Resiliency In Childhood Cancer Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 3 to 25 years at enrollment
- Diagnosed with solid tumors of the chest, abdomen, or extremities including neuroblastic tumors, sarcoma (soft tissue and bone), kidney tumors, liver tumors, ovarian tumors, lung and pleural tumors, or intestinal tumors
- Primary caregiver or guardian of a patient aged 3 to 25 years with one of the listed tumors and agreeing to participate
You will not qualify if you...
- Known pregnancy
- Current prisoner status
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 1 year
Participants wear a smartwatch starting before surgery and continuing for one year to collect activity, heart rate, and sleep data. Patient-reported outcome questionnaires are completed at enrollment, before surgery if applicable, and multiple times up to one year after surgery. Blood samples may be collected alongside routine blood draws preoperatively and at intervals after surgery for biomarker testing.
Questionnaires completed at enrollment, pre-surgery if applicable, and at 1, 2, 4, 8, 12, 16, 20, 24, 34, 44, and 54 weeks post-surgery
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55901
Actively Recruiting
Research Team
M
Mayo Clinic Pediatric Surgery Clinical Research Unit
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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