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

Not yet recruiting

• Conditions: Chemotherapy Effect; Cancer

• Registration Number: NCT04891952
• Lead Sponsor: Animated Dynamics, Inc.

Brief Summary

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

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.

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-13
• Last Update Submitted: 2021-05-13
• Study First Posted: 2021-05-19
• Last Update Posted: 2021-05-19
• Study Start: 2021-08-01
• Primary Completion: 2031-08-01
• Study Completion: 2031-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Histologically proven cancer of any type
2. Onco4D® test ordered by treating physician
3. Ability to understand and willingness to sign an informed consent
4. ≥ 18 years old at time of consent

Exclusion Criteria

n/a

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathologic complete response (pCR) to neoadjuvant chemotherapy	1 year	Difference in pathologic complete response (pCR) to neoadjuvant chemotherapy among recipients of Onco4D® guided therapy as compared to baseline unguided pCR rates

Secondary Outcome Measures

Name	Time	Method
2 and 5 year Event Free Survival (EFS)	2 and 5 years	2 and 5 year Event Free Survival (EFS)
radiologic chemotherapy response	1 year	radiologic chemotherapy response
Distribution of chemotherapy regimens prescribed	1 year	Distribution of chemotherapy regimens prescribed

Trial Locations

Locations (1)

Animated Dynamics, Inc.; 🇺🇸 Indianapolis, Indiana, United States