NCT06674811

Biomarkers of Resiliency In Childhood Cancer Surgery

Digital Biomarker and Omics-Based Assessment of Surgical Resiliency in Children Undergoing Solid Tumor Resection: A Pilot Feasibility Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 3 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

This observational study is to better understand how children and their families recover after the stress of major surgery for cancer so that investigators can create ways to improve resilience during recovery. The main questions it aims to answer are: 1. Can information obtained from patients and their caregivers wearing smartwatches and answering questionnaires be used to measure how patients are recovering from surgery? 2. Are there specific patterns in patients' circulating proteins and metabolites that are associated with stress after surgery? Participants, including pediatric patients undergoing surgery for cancer and their primary caregiver, will be asked to: * wear a smartwatch * complete questionnaires * allow for extra blood to be drawn for this research study when they are having their regular blood draws for clinical purposes These actions will occur at baseline prior to patients' surgery and then afterwards for up to one year. There are no changes to participants' clinical care or surgical care as a result of the study. Investigators will also collect participants' clinical information and cancer-specific outcomes. Participants will be remunerated for their time.

Conditions

• Pediatric Cancer
• Neuroblastoma
• Sarcoma
• Wilms Tumor and Other Childhood Kidney Tumors
• Childhood Soft Tissue Sarcoma
• Childhood Bone Sarcoma
• Childhood Malignant Intestinal Neoplasm
• Childhood Malignant Liver Neoplasm
• Childhood Malignant Lung Neoplasm
• Childhood Malignant Ovarian Neoplasm
• Childhood Malignant Pleural Neoplasm
• Childhood Neuroblastic Tumor
• Childhood Sarcoma

Interventions

Type	Name	Description
OTHER	Wearing Smartwatch	Patients and their caregivers will be asked to start wearing a smartwatch prior to surgery and continuing to wear it for one year following surgery at all times except when bathing or swimming, eating, undergoing a procedure, or if refusing to wear them. The smartwatches collect motor activity by minutes spent being sedentary, active, or highly active, heart rate, and sleep duration and stages. Data from the smartwatches syncs with Garmin connect using Fitabase to allow the study team to review the data.
OTHER	Patient Report Outcomes	To obtain patient-reported outcomes (PROs), questionnaires will be administered at time of enrollment, in the two weeks prior to surgery if applicable, and at 1, 2, 4, 8, 12, 16, 20, 24, 34, 44, and 54 weeks postoperatively. Questionnaires can be completed electronically, over the telephone or in person. The PedsQL Cancer Module and Patient Health Questionnaire depression scale (PHQ-9) will be utilized for questionnaires.
OTHER	Blood Draw	When patients are having blood drawn as part of their regular care, extra blood may be drawn for this study. Participants may opt out of this. Blood draws will occur preoperatively and at intervals postoperatively for proteomic, metabolomic, and exposomic testing.
OTHER	Clinical Data Review	Clinical data will be collected and stored in a database by study staff. This includes patient demographics, diagnosis characteristics including staging and risk group, treatment characteristics, and outcomes including length of stay following surgical intervention, readmissions, surgical complications including surgical site infection, time off therapy/time to resumption of chemotherapy.

Timeline

• Start date: 2025-01-16
• Primary completion: 2030-01-01
• Completion: 2030-01-01
• First posted: 2024-11-05
• Last updated: 2026-01-26

Locations

1 site across 1 country: United States