Measuring the Impact of Onco4D® Guidance on Chemotherapy Selection and Outcomes

Study Overview
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Brief Summary
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Millions of cancer patients each year receive chemotherapy causing adverse side effects that lower quality of life without prolonging it. Reliable identification of ineffective therapies can eliminate needless human suffering while increasing overall probability of positive response to treatment. Chemotherapy resistance profiling entails testing whether a patient exhibits strong resistance to a therapy prior to its final selection by the oncologist. The Onco4D® chemotherapy selection assay has recently emerged as means to measure the response of intact tumor biopsies to applied therapeutics by using Doppler detection of infrared light scattered from intracellular motions inside living tissue (known as Motility Contrast Tomography or MCT). Several studies have shown this phenotypic profiling technique to offer high accuracy predicting response and resistance to chemotherapy[1-5].

Detailed Description
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SPECIFIC AIMS The scope of this study is to measure the impact of Onco4D® therapy guidance on treatment and outcomes among cancer patients for whom the test is ordered. PRIMARY ENDPOINT: Difference in pathologic complete response (pCR) to neoadjuvant chemotherapy among recipients of Onco4D® guided therapy as compared to baseline unguided pCR rates. SECONDARY ENDPOINTS: Difference in distribution of chemotherapy regimens among recipients of Onco4D® guided therapy as compared to baseline unguided regimens, adjuvant chemotherapy response, 2 and 5 year event free survival (EFS), pre- and post-chemotherapy cancer staging scores (TNM, ACJJ, RCB, etc..), radiologic chemotherapy response, additional exploratory endpoints as appropriate RESEARCH DESIGN AND METHODS STUDY DESIGN: Non-randomized multi-center prospective outcomes registry PARTICIPANT IDENTIFICATION: Cancer patients of all races and ethnic groups are eligible for this registry. All patients treated at participating sites and meeting the inclusion criteria will be offered the opportunity to participate in the registry. Potential participants will be presented with the purpose of the study and the potential risks and benefits of participation. Participants will be considered registered to the study upon receipt of a signed informed consent statement. Registration information will be maintained by the Principal Investigator. All participants will be assigned a unique study ID.

Official Title
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Measuring the Impact of Onco4D® Guidance

Conditions
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Cancer, Chemotherapy Effect

Intervention / Treatment
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* Diagnostic Test: Onco4D Biodynamic Chemotherapy Selection Assay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven cancer of any type Onco4D® test ordered by treating physician Ability to understand and willingness to sign an informed consent ≥ 18 years old at time of consent Exclusion Criteria: n/a
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Onco4D Biodynamic Chemotherapy Selection Assay|Functional precision medicine test to predict response to candidate chemotherapeutic agents|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic complete response (pCR) to neoadjuvant chemotherapy | Difference in pathologic complete response (pCR) to neoadjuvant chemotherapy among recipients of Onco4D® guided therapy as compared to baseline unguided pCR rates | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of chemotherapy regimens prescribed | Distribution of chemotherapy regimens prescribed | 1 year | 
| 2 and 5 year Event Free Survival (EFS) | 2 and 5 year Event Free Survival (EFS) | 2 and 5 years | 
| radiologic chemotherapy response | radiologic chemotherapy response | 1 year |