Biomarkers of Resiliency In Childhood Cancer Surgery

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06674811
Status
Recruiting
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Conditions

  • 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
  • Childhood Soft Tissue Sarcoma
  • Neuroblastoma
  • Pediatric Cancer
  • Sarcoma
  • Wilms Tumor and Other Childhood Kidney Tumors

Eligibility Criteria

Sex
ALL
Age
3 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Wearing Smartwatch — OTHER
    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.
  • Patient Report Outcomes — OTHER
    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.
  • Blood Draw — OTHER
    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.
  • Clinical Data Review — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jan 16, 2025
Status verified
Jan 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: Patient
    Children and young adults 3-18 years old who are undergoing surgical resection of an extracranial solid tumor.
  • Arm: Caregiver
    Primary caregiver or parent of a a child or young adults 3-18 years old who is undergoing surgical resection for an extracranial solid tumor and has agreed to participate in the study.

Primary Outcome Measure

Surgical resilience [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55901
Stephanie F Polites, MD, MPH
[email protected]
507-284-2623

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