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

NCT06423950 | Recruiting

• 1 other identifier: MCC-22170
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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)

Interventions

Peds Evolutionary Tumor Board (pedsETB) OTHER

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.

Participants Reviewed by ETB

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who are patients at participating pedsETB sites.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Pediatric Cancer Foundation: collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Related Links

• Moffitt Cancer Center Clinical Trials Website

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood collected at study enrollment and subsequently at designated time points: Screening/Baseline/Enrollment, first post pedsETB Visit, and every 12 weeks (+/- 6 weeks) or upon changes in disease status, therapeutic intervention, and/or events of special interest at the discretion of the treating physician.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jonathan Metts, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Crimella

CONTACT

813-745-6250; Jessica.Crimella@moffitt.org

Jonathan Metts, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 21, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (1)