About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
Disqualifiers
Participants without known therapies to reliably induce a response are excluded from pedsETB and should seek clinical trials.
Trial population
Participants who are patients at participating pedsETB sites.
Trial design
Case-only
Prospective
Treatments tested in this trial
Peds Evolutionary Tumor Board (pedsETB)
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
National Pediatric Cancer Foundation
Collaborator