Biomarkers of Resiliency In Childhood Cancer Surgery (BRICCS)

Mayo Clinic

Status: Enrolling

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

Treatments: Other: Patient Report Outcomes; Other: Wearing Smartwatch; Other: Blood Draw; Other: Clinical Data Review

Study type: Observational

Funder types: Other

Identifiers

NCT06674811

24-005929 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 3 to 25 years old

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 2 patient groups

Patient

Description:

Children and young adults 3-18 years old who are undergoing surgical resection of an extracranial solid tumor.

Treatment:

Other: Clinical Data Review

Other: Blood Draw

Other: Patient Report Outcomes

Other: Wearing Smartwatch

Caregiver

Description:

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.

Treatment:

Other: Patient Report Outcomes

Other: Wearing Smartwatch