Measuring the Impact of Onco4D® Guidance on Chemotherapy Selection and Outcomes
NCT ID: NCT04891952
Last Updated: 2021-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
1000 participants
OBSERVATIONAL
2021-08-01
2031-08-01
Brief Summary
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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\[1-5\].
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Interventions
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Onco4D Biodynamic Chemotherapy Selection Assay
Functional precision medicine test to predict response to candidate chemotherapeutic agents
Eligibility Criteria
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Inclusion Criteria
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
ALL
No
Sponsors
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Purdue University
OTHER
Animated Dynamics, Inc.
INDUSTRY
Responsible Party
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Locations
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Animated Dynamics, Inc.
Indianapolis, Indiana, United States
Countries
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References
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Whitacre E, Manahan E, Burak W, Morgan T, An R, Loesch D: Abstract P3-11-17: A novel biodynamic imaging assay predicts success or failure of neoadjuvant chemotherapy in breast cancer patients. Cancer Research 2019, 79(4 Supplement):P3-11-17.
Turek JJ, Nolte DD, An R: Abstract 2849: Biodynamic imaging predicts response of breast cancer patients to neoadjuvant chemotherapy. Cancer Research 2018, 78(13 Supplement):2849.
Choi H, Li Z, Sun H, Merrill D, Turek J, Childress M, Nolte D. Biodynamic digital holography of chemoresistance in a pre-clinical trial of canine B-cell lymphoma. Biomed Opt Express. 2018 Apr 17;9(5):2214-2228. doi: 10.1364/BOE.9.002214. eCollection 2018 May 1.
Sun H, Merrill D, An R, Turek J, Matei D, Nolte DD. Biodynamic imaging for phenotypic profiling of three-dimensional tissue culture. J Biomed Opt. 2017 Jan 1;22(1):16007. doi: 10.1117/1.JBO.22.1.016007.
Merrill D, An R, Sun H, Yakubov B, Matei D, Turek J, Nolte D. Intracellular Doppler Signatures of Platinum Sensitivity Captured by Biodynamic Profiling in Ovarian Xenografts. Sci Rep. 2016 Jan 6;6:18821. doi: 10.1038/srep18821.
Other Identifiers
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003
Identifier Type: -
Identifier Source: org_study_id
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