Generating Novel Therapeutic Strategies Based on Evolutionary Tumor Board

Recruiting

• Conditions: Incurable Disease
• Interventions: Other: Evolutionary Tumor Board (ETB)

• Registration Number: NCT04343365
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-09
• Study First Posted: 2020-04-13
• Study Start: 2020-05-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Primary Completion: 2028-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants Reviewed by ETB	Evolutionary Tumor Board (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.

Primary Outcome Measures

Name	Time	Method
ETB developing therapeutic strategies	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.

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States