Biomarkers of Resiliency In Childhood Cancer Surgery

NCT06674811 | Recruiting

• 1 other identifier: 24-005929
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (3)

• Quality of life - PedsQL

  1 year

• Quality of life - PHQ-9

  1 year

• Biomarkers

  1 year

Study Arms (2)

Patient

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

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.

Other: Wearing Smartwatch; Other: Patient Report Outcomes

Interventions

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.

Patient

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.

Caregiver; Patient

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.

Caregiver; Patient

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.

Patient

Eligibility Criteria

• Age: 3 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients who are known to be pregnant or prisoners.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55901, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be used for future proteomic, metabolomic, and exposomic testing.

MeSH Terms

Conditions

Neoplasms; Neuroblastoma; Sarcoma; Wilms Tumor

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms, Complex and Mixed; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Stephanie Polites, M.D., M.P.H.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mayo Clinic Pediatric Surgery Clinical Research Unit

CONTACT

507-266-4467; DOSCRO2@mayo.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery, Assistant Professor of Health Services Research

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: January 16, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)