Generating Novel Translational and Therapeutic Strategies Based on a Multicenter, Pediatric and AYA Evolutionary Tumor Board (pedsETB)

Feasibility of Generating Novel Translational and Therapeutic Strategies Based on a Multicenter, Pediatric and AYA Evolutionary Tumor Board (pedsETB)

To evaluate the ability of a multidisciplinary and multisite group, the Pediatric Evolutionary Tumor Board (pedsETB), to develop additional therapeutic strategies in patients without curative options or with suboptimal outcomes.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Cancer
• Intervention / Treatment: Other: Peds Evolutionary Tumor Board (pedsETB)

• Study Type: Observational
• Enrollment (Estimated): 35

Contacts and Locations

• Study Contact: Name: Jessica Crimella; Phone Number: 813-745-6250; Email: Jessica.Crimella@moffitt.org
• Study Contact Backup: Name: Jonathan Metts, MD

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Principal Investigator: Jonathan Metts, MD
      • Contact: Jessica Crimella; Phone Number: 813-745-6250; Email: Jessica.Crimella@moffitt.org
      • Sub-Investigator: Alexander Anderson, PhD
      • Principal Investigator: Mark Robertson-Tessi, PhD
      • Sub-Investigator: Joel S Brown, PhD
      • Sub-Investigator: Rikesh Makanji, MD
      • Sub-Investigator: Andriy Marusyk, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants who are patients at participating pedsETB sites.

Description

Inclusion Criteria:

• Participant must be considered likely incurable given the standard of care. This is inclusive of patients newly diagnosed, relapsed or in remission but at high risk of recurrence, with suboptimal responses to previous therapy, or with many potentially beneficial, but unlikely curative options for care.

The site investigator will make this determination based on their experience.

• Participant must have an age-appropriate performance status: Karnofsky 50 or more for patients 16 years of age or older OR Lansky score of 50 or more for patients less than16 years of age.
• Participant and/or parents or legal guardian and primary oncologist must be willing to consider the therapeutic strategies recommended by the pedsETB.
• Participant must be willing to be followed over time and allow collection of clinical data including scans, available blood and lab samples, and optional pedsETB serial blood sampling.
• All Participants and/or their parents or legal guardians must have the ability to understand and the willingness to sign a written informed consent or assent document.

Exclusion Criteria:

• Participants without known therapies to reliably induce a response are excluded from pedsETB and should seek clinical trials.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Participants Reviewed by ETB; Participants clinical history, available therapeutic options, and outcome expectations will be presented to the Evolutionary Tumor Board (ETB) along with images and pathology. Strategies and models will be presented regarding additional evolutionary ideas that can be applied. These ideas will be characterized (e.g. first strike-second strike, adaptive, novel sequential therapy, novel combination, novel dosing schedule, etc.).

Other: Peds Evolutionary Tumor Board (pedsETB); The pedsETB consists of evolutionary biologists, mathematicians, research scientists, statisticians, data scientists, radiologists, pathologists, oncologists (surgical, radiation, medical, and pediatric), and clinical trial coordinators. The pedsETB membership is inclusive of members from the participating institutions. The pedsETB will generate hypotheses, mathematical models, and experiments from the discussion towards further integration of evolutionary ideas towards therapeutic strategies for participants. The pedsETB will collect data through a chart review regarding adherence and results of ETB recommendation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The feasibility of the pedsETB developing therapeutic strategies	The investigators will measure the ability of a multidisciplinary group, the pedsETB, to develop additional therapeutic strategies in patients without curative options. The investigators plan to enroll 35 patients on the study. The primary objective will be successfully met if the pedsETB can develop an evolutionary based therapeutic strategy that differs from the oncologist's opinion prior to presentation for at least 80%, or 28 of these patients.	Baseline to up to 60 months from end of therapy

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: National Pediatric Cancer Foundation
• Investigators: Principal Investigator: Jonathan Metts, MD, Moffitt Cancer Center

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: May 9, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 21, 2024

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: MCC-22170

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No