Incurable DiseaseNCT04343365
Generating Novel Therapeutic Strategies Based on Evolutionary Tumor Board
An observational study of Incurable Disease, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Incurable Disease
- What is being tested?
- Evolutionary Tumor Board (ETB)
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2020to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants who are patients at Moffitt Cancer Center
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33613
Sara Donadelli, 813-745-8111, Sara.Donadelli@moffitt.org
Jingsong Zhang, MD
About this study
Official title: 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.
- Conditions
- Incurable Disease
- Being tested
- Evolutionary Tumor Board (ETB)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Evolutionary Tumor Board (ETB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to up to 60 months from end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start5 May 2020
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incurable DiseaseStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingsong Zhang, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343365
- Sponsor's protocol ID
- MCC-20417
- Status last verified
- Mar 2026
- First submitted
- 9 Apr 2020
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Generating Novel Therapeutic Strategies Based on Evolutionary Tumor Board in Cancer Patients
- ClinicalTrials.gov ID
- NCT04343365
- Acronym / sponsor ID
- MCC-20417
- Conditions
- Incurable Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 5 May 2020 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Reviewed by ETB | – | Other: 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who are patients at Moffitt Cancer Center
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Participants Reviewed by ETB |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jingsong Zhang, MD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incurable Disease, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Donadelli (813-745-8111, Sara.Donadelli@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ETB developing therapeutic strategies (time frame: Baseline to up to 60 months from end of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.