Generating Novel Therapeutic Strategies Based on Evolutionary Tumor Board

NCT04343365 | Recruiting

• 1 other identifier: MCC-20417
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Incurable Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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)

Interventions

Evolutionary Tumor Board (ETB) OTHER

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

Participants Reviewed by ETB

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who are patients at Moffitt Cancer Center

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33613, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood collected, and subsequently at designated time points (every 9 weeks from ETB result discussion +/- 4 weeks) depending on the upfront treatment protocol, off therapy, and at disease relapse. For each collection, a total of 20 mL of blood will be drawn, which includes 10 ml of blood in an EDTA tube, and 10 ml in a LBGuard® tube, as described in Lab Manual.

Study Officials

• Jingsong Zhang, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Donadelli

CONTACT

813-745-8111; Sara.Donadelli@moffitt.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 13, 2020
• Study Start: May 5, 2020
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (1)