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Trial record 1 of 1 for:    KIYATEC
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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 : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
KIYATEC

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.

Condition or disease Intervention/treatment
Advanced Cancer Ovarian Cancer Glioblastoma Multiforme Anaplastic Astrocytoma Diagnostic Test: EV3D Assay

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).

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 570 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: 3D-PREDICT REGISTRY: 3D Prediction of Patient-specific Response Using Ex Vivo Interrogation of Live Cells From Tumors
Actual Study Start Date : June 11, 2018
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2024


Group/Cohort Intervention/treatment
Tumor tissue tested with EV3D Assay
Cancer tissue from multiple sites in the body, to include ovarian, brain, and other rare tumors.
Diagnostic Test: EV3D Assay
The EV3D assay uses freshly obtained tumor specimen to predict tissue drug response.




Primary Outcome Measures :
  1. Establish correlation of Assay results with patient outcomes [ Time Frame: 2 year ]
    Compare Assay results to reported patient outcomes


Secondary Outcome Measures :
  1. Evaluate the use of Assay results and the effects on medical decision-making and patient outcomes [ Time Frame: 2 year ]
    Determine potential effect of Assay results on treatment plan

  2. Compare clinical response (progression free survival or time to progression) in patients who receive treatment aligned with Assay results of response versus patients who are not treated aligned with Assay results of response [ Time Frame: 2 years ]
    Compare Assay results to study patient clinical response

  3. Compare clinical response (progression free survival or time to progression) in patients who receive treatment aligned with Assay results of response versus historical response rates [ Time Frame: 2 years ]
    Compare Assay results to historical clinical response rates

  4. Compare clinical outcomes (event free survival and overall survival) in patients who are treated aligned with Assay results versus historical response rates [ Time Frame: 2 years ]
    Compare survival of study patients aligned with Assay results to historical survival rates

  5. Define Assay success across histologic subtypes and classes of anti-cancer compounds [ Time Frame: 2 years ]
    Evaluate Assay success rate


Biospecimen Retention:   Samples With DNA
Fresh tumor tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Age 18 years and older
  • Diagnosis of or suspected diagnosis of EOC, HGG, high-grade RT
  • Individual must undergo elective surgery or biopsy to remove tumor tissue
  • Consideration as a candidate for systemic therapy with cytotoxic chemotherapy, targeted small molecule inhibitors or immunotherapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 3
  • Written informed consent in accordance with institutional standards must be obtained from the patient or legal guardian

Exclusion Criteria:

  • Inability or refusal of the patient or legal guardian to sign a written informed consent
  • Failure to have surgery or a biopsy as part of routine clinical practice
  • Refusal to have the Assay performed on their tissue
  • Known active cancer metastatic to the brain except for patients with brain metastases that have been treated and are considered stable.
  • Inability or unwillingness to receive chemotherapy treatment beyond surgery
  • Any coincidental medical condition that, in the Investigator's opinion, would preclude participation in the study or compromise the patient's ability to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561207


Contacts
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Contact: Cecile Rose T Vibat, PhD 864-502-2013 cecilerose.vibat@kiyatec.com

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Nicolas A Butowski, MD         
Principal Investigator: Nicolas A Butowski, MD         
United States, New Jersey
Capital Health Institute for Neurosciences Recruiting
Trenton, New Jersey, United States, 08638
Contact: Navid Redjal, MD, FAANS         
Principal Investigator: Navid Redjal, MD, FAANS         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14203
Contact: Adekunle Odunsi, MD, PhD         
Principal Investigator: Adekunle Odunsi, MD, PhD         
Principal Investigator: Robert Fenstermaker, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Koenraad De Geest, MD         
Principal Investigator: Koenraad De Geest, MD         
Principal Investigator: Seunggu Han, MD         
Veterans Administration Portland Health Care System Recruiting
Portland, Oregon, United States, 97239
Contact: Seunggu J Han, MD         
Principal Investigator: Seunggu J Han, MD         
United States, South Carolina
Prisma Health Recruiting
Greenville, South Carolina, United States, 29605
Contact: William J Edenfield, MD         
Principal Investigator: William J Edenfield, MD         
United States, Virginia
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: George L Maxwell, MD         
Principal Investigator: George L Maxwell, MD         
Sponsors and Collaborators
KIYATEC
Investigators
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Study Director: Cecile Rose T Vibat, PhD KIYATEC
Additional Information:
Publications:
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Responsible Party: KIYATEC
ClinicalTrials.gov Identifier: NCT03561207    
Other Study ID Numbers: KIY-REG-001
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Neoplasms
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue