Pediatric CancerBRICCSNCT06674811
Biomarkers of Resiliency In Childhood Cancer Surgery
An observational study of Pediatric Cancer and Neuroblastoma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 25 years
- Conditions the study is for
- Pediatric Cancer, Neuroblastoma, Sarcoma
- What is being tested?
- Wearing Smartwatch, Patient Report Outcomes and Blood Draw
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 31 Jan 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients who are known to be pregnant or prisoners.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55901
Stephanie F Polites, MD, MPH, 507-284-2623, polites.stephanie@mayo.edu
About this study
Official title: 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:
- Can information obtained from patients and their caregivers wearing smartwatches and answering questionnaires be used to measure how patients are recovering from surgery?
- Are there specific patterns in patients' circulating proteins and metabolites that are associated with stress after surgery?
Read more
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
- Being tested
- Wearing Smartwatch, Patient Report Outcomes, Blood Draw, Clinical Data Review
- Keywords
- digital biomarker, remote monitoring, smartwatch, surgery, pediatric cancer
- Medical subject headings
- Neoplasms, Neuroblastoma, Sarcoma, Wilms Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearing SmartwatchOther
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 OutcomesOther
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 DrawOther
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 ReviewOther
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 group | Role | What they receive |
|---|---|---|
| Patient | Children and young adults 3-18 years old who are undergoing surgical resection of an extracranial solid tumor. Receives: Other: Wearing Smartwatch; Other: Patient Report Outcomes; Other: Blood Draw; Other: Clinical Data Review | |
| 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. Receives: Other: Wearing Smartwatch; Other: Patient Report Outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical resilience
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.
Measured: 1 year
Secondary outcomes (3)
Quality of life - PedsQL
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.
Measured: 1 year
Quality of life - PHQ-9
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.
Measured: 1 year
Biomarkers
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start15 Jan 2025
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Polites, M.D., M.P.H., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674811
- Sponsor's protocol ID
- 24-005929
- Other IDs
- 24-005929
- Acronym
- BRICCS
- Status last verified
- Sep 2026
- First submitted
- 4 Nov 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Investigators do not plan to share IPD to protect participants' confidentiality.