3D Prediction of Patient-Specific Response (3D-PREDICT)
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ClinicalTrials.gov Identifier: NCT03561207 |
Recruitment Status :
Recruiting
First Posted : June 19, 2018
Last Update Posted : December 17, 2020
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Sponsor:
KIYATEC
Information provided by (Responsible Party):
KIYATEC
Tracking Information | |||||
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First Submitted Date | June 10, 2018 | ||||
First Posted Date | June 19, 2018 | ||||
Last Update Posted Date | December 17, 2020 | ||||
Actual Study Start Date | June 11, 2018 | ||||
Estimated Primary Completion Date | June 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Establish correlation of Assay results with patient outcomes [ Time Frame: 2 year ] Compare Assay results to reported patient outcomes
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Original Primary Outcome Measures |
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Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | 3D Prediction of Patient-Specific Response | ||||
Official Title | 3D-PREDICT REGISTRY: 3D Prediction of Patient-specific Response Using Ex Vivo Interrogation of Live Cells From Tumors | ||||
Brief Summary | This is a prospective, non-randomized, observational registry study evaluating a patient-specific ex vivo 3D (EV3D) assay for drug response using a patient's own biopsy or resected tumor tissue for assessing tissue response to therapy in patients with advanced cancers, including ovarian cancer, high-grade gliomas, and high-grade rare tumors. | ||||
Detailed Description | This protocol defines a prospective, open-label, multi-institutional, non-interventional study for the purpose of examining the Assay's clinical use and potential to impact patient outcomes. This Study will establish a registry of clinical parameters, including clinical response, clinical outcomes, Assay performance and potential utilization across multiple types of advanced cancers in consenting patients who have their tumor tissue tested by the Assay. Physicians may have access to Assay results which which predict therapeutic response to cancer drugs most often prescribed to treat the specified indications. For cancers with standard of care (SOC) cancer drug treatments, the Assay panel tests SOC systemic agents per NCCN guidelines, some of which may include both FDA approved and off-label FDA approved therapies. The Assay currently assesses the most common cancer drugs across multiple tumor types. It requires freshly obtained tumor specimen that has not been previously preserved for traditional histologic analysis. The Registry will focus initially on tumor types and agents which have been analytically validated with the Assay and determined to meet strict laboratory qualifications and standards. The Registry will collect data on a limited number of cancer types to include epithelial ovarian cancer (EOC), high-grade gliomas (HGG) limited to anaplastic astrocytoma (AA) and glioblastoma multiforme (GBM), and high-grade rare tumors (RT). | ||||
Study Type | Observational [Patient Registry] | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | 2 Years | ||||
Biospecimen | Retention: Samples With DNA Description: Fresh tumor tissue
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Sampling Method | Probability Sample | ||||
Study Population | Patients with suspected, newly diagnosed or relapsed diagnosis of advanced cancer (ovarian, brain, or other rare tumors) undergoing surgery or biopsy to remove tumor tissue will be enrolled and their tissue collected and tested with the EV3D Assay across drugs that are most often used to treat the specified cancer types, including standard of care therapies or as recommended by NCCN guidelines. | ||||
Condition |
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Intervention | Diagnostic Test: EV3D Assay
The EV3D assay uses freshly obtained tumor specimen to predict tissue drug response.
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Study Groups/Cohorts | Tumor tissue tested with EV3D Assay
Cancer tissue from multiple sites in the body, to include ovarian, brain, and other rare tumors.
Intervention: Diagnostic Test: EV3D Assay
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Publications * | Shuford S, Wilhelm C, Rayner M, Elrod A, Millard M, Mattingly C, Lotstein A, Smith AM, Guo QJ, O'Donnell L, Elder J, Puls L, Weroha SJ, Hou X, Zanfagnin V, Nick A, Stany MP, Maxwell GL, Conrads T, Sood AK, Orr D, Holmes LM, Gevaert M, Crosswell HE, DesRochers TM. Prospective Validation of an Ex Vivo, Patient-Derived 3D Spheroid Model for Response Predictions in Newly Diagnosed Ovarian Cancer. Sci Rep. 2019 Aug 1;9(1):11153. doi: 10.1038/s41598-019-47578-7. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
570 | ||||
Original Estimated Enrollment |
640 | ||||
Estimated Study Completion Date | December 2024 | ||||
Estimated Primary Completion Date | June 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03561207 | ||||
Other Study ID Numbers | KIY-REG-001 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | KIYATEC | ||||
Study Sponsor | KIYATEC | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | KIYATEC | ||||
Verification Date | December 2020 |