Generating Novel Therapeutic Strategies Based on Evolutionary Tumor Board

February 13, 2024 updated by: H. Lee Moffitt Cancer Center and Research Institute

Feasibility of Generating Novel Therapeutic Strategies Based on Evolutionary Tumor Board in Cancer Patients

This study will evaluate the ability of a multidisciplinary group, the Evolutionary Tumor Board (ETB), to develop therapeutic strategies in patients without curative options.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33613
        • Recruiting
        • Moffitt Cancer Center
        • Sub-Investigator:
          • Michael Schell, PhD
        • Principal Investigator:
          • Christine Chung, MD
        • Sub-Investigator:
          • Joel Brown, PhD
        • Sub-Investigator:
          • Alexander Anderson, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants who are patients at Moffitt Cancer Center

Description

Inclusion Criteria:

  • Participant must be considered likely incurable given a standard of care. This is inclusive of participants in remission but at high risk of recurrence, with suboptimal responses to previous therapy, or with many potentially beneficial, but not curative options for care.
  • Participant must have a life expectancy greater than 3 months
  • Participant must have an ECOG performance status 0-2
  • Participant and primary Oncologist are willing to consider the therapeutic strategies recommended by the ETB
  • Willingness to be followed over time and allowing collection of clinical data including scans and serial blood sampling.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Evolutionary Tumor Board (ETB)
The ETB consists of evolutionary biologists, mathematicians, research scientists, statisticians,data scientists, radiologists, pathologists, oncologists (surgical, radiation, medical, and pediatric), and clinical trial coordinators.The ETB will generate hypotheses, mathematical models, and experiments from the discussion towards further integration of evolutionary ideas towards therapeutic strategies for participants. The ETB will collect data through a chart review regarding adherence and results of ETB recommendation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ETB developing therapeutic strategies
Time Frame: Baseline to up to 60 months from end of therapy
The investigators want to demonstrate the ability of a multidisciplinary group, the ETB, to develop therapeutic strategies in participants without curative options. They plan to enroll 35 patients to this study over 3 years. The primary objective will be successfully met if they can develop an evolutionary based plan that differs from the participants options prior to presentation for at least 80%, or 28 of these participants.
Baseline to up to 60 months from end of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: Christine Chung, MD, Moffitt Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2020

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

April 9, 2020

First Submitted That Met QC Criteria

April 9, 2020

First Posted (Actual)

April 13, 2020

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • MCC-20417

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Incurable Disease

Clinical Trials on Evolutionary Tumor Board (ETB)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe