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

NCT ID: NCT06423950

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pediatric Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.).

Peds Evolutionary Tumor Board (pedsETB)

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Pediatric Cancer Foundation

OTHER

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Metts, MD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

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Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jessica Crimella

Role: CONTACT

Phone: 813-745-6250

Email: [email protected]

Jonathan Metts, MD

Role: CONTACT

Facility Contacts

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Jessica Crimella

Role: primary

Other Identifiers

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MCC-22170

Identifier Type: -

Identifier Source: org_study_id