Generating Novel Therapeutic Strategies Based on Evolutionary Tumor Board

Incurable Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04343365
• Other study ID #: MCC-20417
• Status: Recruiting
• Start date: May 5, 2020
• Est. completion date: March 2028

Study information

• Verified date: February 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Alaa Taha
• Phone: 813-745-7025
• Email: Alaa.Taha[@]moffitt.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Incurable Disease

Intervention

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

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ETB developing therapeutic strategies	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