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Biomarkers of Resiliency In Childhood Cancer Surgery

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
3 Years to 25 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Can information obtained from patients and their caregivers wearing smartwatches and answering questionnaires be used to measure how patients are recovering from surgery? 2."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how children and young adults ages 3–25 and their caregivers recover from the stress of cancer surgery. It uses smartwatches, surveys, and extra blood collected during regular blood draws to track recovery and signs of stress for up to one year after surgery. The study does not change medical or surgical care.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Patients must be ages 3–25 when they join.
  • Patients must have a solid tumor in the chest, belly, arms, or legs. Listed types include tumors of nerve cells, soft tissue, bone, kidneys, liver, ovaries, lungs, the lining around the lungs, or intestines.
  • A guardian or main caregiver of a patient ages 3–25 with one of these tumors may also join.

Who can't join

  • Patients who are known to be pregnant.
  • Patients who are prisoners.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

MN