Recruiting

Observational Study

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT06423950

Conditions

Pediatric Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Peds Evolutionary Tumor Board (pedsETB)

Study Details

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

Study ID

NCT06423950

Start date

May 1, 2024

Status verified date

Sep, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

35 participants

Anticipated

Interventions and Outcome Measures

Arms

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.).

Interventions

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.

Primary outcome measure

  • The feasibility of the pedsETB developing therapeutic strategies [ Time Frame: Baseline to up to 60 months from end of therapy ]

Central Contacts and Locations

Central contacts

Jessica Crimella

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

Locations

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06106

Principal Investigator:

Mike Isakoff, MD

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Jessica Crimella

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

Principal Investigator:

Jonathan Metts, MD

Roswell Park Comprehensive Cancer Center

Recruiting

Buffalo, New York, United States, 14203

Principal Investigator:

Ajay Gupta, MD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-09-03.