RECRUITING

Biomarkers of Resiliency in Childhood Cancer Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-16
Study Completion:2030-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06674811

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 3-18 years old at enrollment
  2. * With solid tumors of the chest, abdomen, and extremities including neuroblastic tumors, sarcoma including soft tissue and bone, kidney tumors, liver tumors, ovarian tumors, lung and pleural-based tumors, and intestinal tumors
  3. * Guardian or primary caregiver of patient 3-18 years old with one of the aforementioned tumors.
  1. * Patients who are known to be pregnant or prisoners.

Contacts and Locations

Study Contact

Mayo Clinic Pediatric Surgery Clinical Research Unit
CONTACT
507-266-4467
DOSCRO2@mayo.edu

Principal Investigator

Stephanie Polites, M.D., M.P.H.
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic
Rochester, Minnesota, 55901
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Stephanie Polites, M.D., M.P.H., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-16
Study Completion Date2030-01

Study Record Updates

Study Start Date2025-01-16
Study Completion Date2030-01

Terms related to this study

Keywords Provided by Researchers

  • digital biomarker
  • remote monitoring
  • smartwatch
  • surgery
  • pediatric cancer

Additional Relevant MeSH Terms

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