Biomarkers of Resiliency In Childhood Cancer Surgery (BRICCS)

January 22, 2026 updated by: Stephanie F. Polites, MD, MPH, Mayo Clinic

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mayo Clinic Pediatric Surgery Clinical Research Unit
  • Phone Number: 507-266-4467
  • Email: DOSCRO2@mayo.edu

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children and young adults 3-18 years old who are undergoing surgical resection for an extracranial solid tumor and their primary caregiver or guardian.

Description

Inclusion Criteria:

  • 3-25 years old at enrollment
  • 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

-OR-

  • Guardian or primary caregiver of patient 3-25 years old with one of the aforementioned tumors.

Exclusion Criteria:

  • Patients who are known to be pregnant or prisoners.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient
Children and young adults 3-18 years old who are undergoing surgical resection of an extracranial solid tumor.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical resilience
Time Frame: 1 year
Using smartwatches, we will assess motor activity by minutes spent being sedentary, active, or highly active, heart rate, and sleep duration and stages. This information will be collected before and after surgical resection. Data from the smartwatches syncs with Garmin connect using Fitabase which allows the study team to monitor and analyze the data. Results will be correlated with questionnaires responses, to see if there are digital biomarker patterns associated with return to baseline quality of life postoperatively.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life - PedsQL
Time Frame: 1 year
Results from Pediatric Quality of Life Inventory (PedsQL) Brain Tumor Module will be used to evaluate the quality of life outcomes in patients up to 18 years old. PedsQL™ assessments include 23 items answered on a Likert scale where 0=never a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; 4=almost always a problem.
1 year
Quality of life - PHQ-9
Time Frame: 1 year
The Patient Health Questionnaire (PHQ)-9 consists of 9 items related to problems over the last 2 weeks. Items are answered on a 4-point Likert scale where 0=not at all; 1=several days, 2=more than half the days; and 3=nearly every day. If any problem items were indicated, participants are asked to answer a final question with one of the following: not difficult at all; somewhat difficult; very difficult; or extremely difficult.
1 year
Biomarkers
Time Frame: 1 year
Participants who are the patients having surgery will have extra blood collected during routine clinical blood draws over time. This will be used for proteomic, metabolomic, and exposomic testing to see if specific proteins, metabolites, or chemicals are changed from baseline after surgery and if any levels are associated with improved resilience or quality of life.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Stephanie Polites, M.D., M.P.H., 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 Major Dates

Study Start (Actual)

January 16, 2025

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Actual)

November 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-005929 (Other Identifier: Mayo Clinic)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Investigators do not plan to share IPD to protect participants' confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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