NCT04891952|Not Yet RecruitingDMCFDA Device
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Sponsor study identifier
observational
1,000
1 country
1
Study Start
August 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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\[1-5\].
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 11, 2021
Actual (reported)May 19, 2021
Actual (reported)August 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Distribution of chemotherapy regimens prescribed
1 year
2 and 5 year Event Free Survival (EFS)
2 and 5 years
radiologic chemotherapy response
1 year
Functional precision medicine test to predict response to candidate chemotherapeutic agents
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Animated Dynamics, Inc.
Indianapolis, Indiana, 46241, United States
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.
First Submitted
May 11, 2021
First Posted
May 19, 2021
Study Start
August 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 1, 2031
POEM (Practice Of Embracing Each Moment) STUDY
Contact the study team to confirm eligibility.
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.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 19, 2021
Record last verified: 2021-05
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Source: ClinicalTrials.gov.
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