## Protocol Section
### Identification Module
**NCT ID:** NCT06423950

**Brief Title:** Generating Novel Translational and Therapeutic Strategies Based on a Multicenter, Pediatric and AYA Evolutionary Tumor Board (pedsETB)

**Official Title:** Feasibility of Generating Novel Translational and Therapeutic Strategies Based on a Multicenter, Pediatric and AYA Evolutionary Tumor Board (pedsETB)

#### Organization Study ID Info
**ID:** MCC-22170
#### Organization
**Class:** OTHER
**Full Name:** H. Lee Moffitt Cancer Center and Research Institute
### Status Module
#### Completion Date
**Date:** 2027-04

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-04

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-30

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** National Pediatric Cancer Foundation

#### Lead Sponsor

**Class:** OTHER

**Name:** H. Lee Moffitt Cancer Center and Research Institute

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** To evaluate the ability of a multidisciplinary and multisite group, the Pediatric Evolutionary Tumor Board (pedsETB), to develop additional therapeutic strategies in patients without curative options or with suboptimal outcomes.

### Conditions Module

**Conditions:**

- Pediatric Cancer

### Design Module

#### Bio Spec

**Description:** Peripheral blood collected at study enrollment and subsequently at designated time points:

Screening/Baseline/Enrollment, first post pedsETB Visit, and every 12 weeks (+/- 6 weeks) or upon changes in disease status, therapeutic intervention, and/or events of special interest at the discretion of the treating physician.

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 35

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

These ideas will be characterized (e.g. first strike-second strike, adaptive, novel sequential therapy, novel combination, novel dosing schedule, etc.).

**Intervention Names:**

- Other: Peds Evolutionary Tumor Board (pedsETB)

**Label:** Participants Reviewed by ETB

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Participants Reviewed by ETB

**Description:** The pedsETB consists of evolutionary biologists, mathematicians, research scientists, statisticians, data scientists, radiologists, pathologists, oncologists (surgical, radiation, medical, and pediatric), and clinical trial coordinators. The pedsETB membership is inclusive of members from the participating institutions. The pedsETB will generate hypotheses, mathematical models, and experiments from the discussion towards further integration of evolutionary ideas towards therapeutic strategies for participants. The pedsETB will collect data through a chart review regarding adherence and results of ETB recommendation.

**Name:** Peds Evolutionary Tumor Board (pedsETB)

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The investigators will measure the ability of a multidisciplinary group, the pedsETB, to develop additional therapeutic strategies in patients without curative options. The investigators plan to enroll 35 patients on the study.

The primary objective will be successfully met if the pedsETB can develop an evolutionary based therapeutic strategy that differs from the oncologist's opinion prior to presentation for at least 80%, or 28 of these patients.

**Measure:** The feasibility of the pedsETB developing therapeutic strategies

**Time Frame:** Baseline to up to 60 months from end of therapy

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Participant must be considered likely incurable given the standard of care. This is inclusive of patients newly diagnosed, relapsed or in remission but at high risk of recurrence, with suboptimal responses to previous therapy, or with many potentially beneficial, but unlikely curative options for care.

The site investigator will make this determination based on their experience.

* Participant must have an age-appropriate performance status: Karnofsky 50 or more for patients 16 years of age or older OR Lansky score of 50 or more for patients less than16 years of age.
* Participant and/or parents or legal guardian and primary oncologist must be willing to consider the therapeutic strategies recommended by the pedsETB.
* Participant must be willing to be followed over time and allow collection of clinical data including scans, available blood and lab samples, and optional pedsETB serial blood sampling.
* All Participants and/or their parents or legal guardians must have the ability to understand and the willingness to sign a written informed consent or assent document.

Exclusion Criteria:

* Participants without known therapies to reliably induce a response are excluded from pedsETB and should seek clinical trials.

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Participants who are patients at participating pedsETB sites.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Jessica.Crimella@moffitt.org

**Name:** Jessica Crimella

**Phone:** 813-745-6250

**Role:** CONTACT

**Contact 2:**

**Name:** Jonathan Metts, MD

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tampa

**Contacts:**

***Contact 1:***

- **Email:** Jessica.Crimella@moffitt.org

- **Name:** Jessica Crimella

- **Phone:** 813-745-6250

- **Role:** CONTACT

***Contact 2:***

- **Name:** Jonathan Metts, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Mark Robertson-Tessi, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Joel S Brown, PhD

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Rikesh Makanji, MD

- **Role:** SUB_INVESTIGATOR

***Contact 6:***

- **Name:** Andriy Marusyk, PhD

- **Role:** SUB_INVESTIGATOR

***Contact 7:***

- **Name:** Alexander Anderson, PhD

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Moffitt Cancer Center

**State:** Florida

**Status:** RECRUITING

**Zip:** 33612

#### Overall Officials

**Official 1:**

**Affiliation:** Moffitt Cancer Center

**Name:** Jonathan Metts, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### See Also Links

**Label:** Moffitt Cancer Center Clinical Trials Website

**URL:** http://moffitt.org/clinical-trials-research/clinical-trials/

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
