ClinicalTrials.gg
RecruitingNCT06423950Updated Nov 12, 2026

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

An observational study in Pediatric Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Recruiting at 6 sites in United States. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Observational

From the registry’s dates

  • Started May 2024; still recruiting 2 years 6 months later.
Updated Nov 12, 20261 site addedGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
35
Sex
All
01

Study 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.

02

Conditions studied

  • Pediatric Cancer

Browse trials for

03

In context

Neoplasms

10,822 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 35 is below the median of 200 across 2,641 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 540 studies on the registry; 75 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants who are patients at participating pedsETB sites.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant must be considered likely incurable given the standard of care. This is inclusive of patients newly diagnosed, 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: 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 or assent document.

Exclusion criteria

Exclusion Criteria:

  • Participants without known therapies to reliably induce a response are excluded from pedsETB and should seek clinical trials.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
35 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • OtherPeds 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.

06

What researchers measure

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.

    Time frame: Baseline to up to 60 months from end of therapy

07

Study locations

6 of 6 sites recruiting
  • Connecticut Children's Medical Center
    Hartford, Connecticut 06106, United States
    Recruiting
    • Mike Isakoff, MD · Principal investigator
  • University of Miami
    Miami, Florida 33136, United States
    Recruiting
    • Aditi Dhir, MD · Principal investigator
  • Moffitt Cancer Center
    Tampa, Florida 33612, United States
    Recruiting
    • Jessica Crimella · ContactJessica.Crimella@moffitt.org · 813-745-6250
    • Jonathan Metts, MD · Principal investigator
    • Mark Robertson-Tessi, PhD · Principal investigator
    • Joel S Brown, PhD · Sub investigator
    • Rikesh Makanji, MD · Sub investigator
    • Andriy Marusyk, PhD · Sub investigator
    • Alexander Anderson, PhD · Sub investigator
  • University of Kentucky
    Lexington, Kentucky 40536, United States
    Recruiting
    • Tom Badgett, MD · Principal investigator
  • Roswell Park Comprehensive Cancer Center
    Buffalo, New York 14203, United States
    Recruiting
    • Ajay Gupta, MD · Principal investigator
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
    Recruiting
    • Bhuvana Setty, MD · Principal investigator
08

References and documents

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2024 (actual). Primary completion is estimated for Apr 2027, 35 months after the start.

Of 1,098 non-industry observational studies under Neoplasms, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 227. This study's planned 35 months is below that.

Counting every sponsor, half of 1,246 studies reached it within 58 months; a quarter within 24 and three quarters within 210.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
May 9, 2024
First posted
May 21, 2024
StartActual
May 1, 2024
Primary completionEst.
Apr 2027
CompletionEst.
Apr 2027
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added
Show site
  • Nationwide Children's Hospital · Columbus, United States
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    1 site added
    Show site
    • Nationwide Children's Hospital · Columbus, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06423950
Collaborators
National Pediatric Cancer Foundation
Responsible party
Sponsor
First posted
May 21, 2024
Start date
May 1, 2024
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Nov 12, 2026

Study contacts

Jessica Crimella
Contact
Jessica.Crimella@moffitt.org
813-745-6250
Jonathan Metts, MD
Contact
Jonathan Metts, MD
principal investigator · Moffitt Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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