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3D-Prediction of Patient-Specific Response (3D-PREDICT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03561207
Recruitment Status : Enrolling by invitation
First Posted : June 19, 2018
Last Update Posted : February 13, 2020
Information provided by (Responsible Party):

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 and Glioblastoma multiforme.

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 will have access to Assay results which is predicting tissue response to standard of care agents. The Assay currently assesses the most common standard of care agents across multiple tumor types and 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) including 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 : December 2021
Estimated Study Completion Date : June 2022

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 ]
    Comparison to reported patient outcomes

  2. 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

Secondary Outcome Measures :
  1. Correlate clinical response (progression free survival or time to progression) to Assay results [ Time Frame: 2 years ]
    Compare effect of Assay results to clinical response

  2. Correlate clinical response (progression free survival or time to progression) to historical response rates [ Time Frame: 2 years ]
    Compare results to historical clinical response rates

  3. Correlate clinical outcomes (progression free survival or time to progression) to historical response rates [ Time Frame: 2 years ]
    Compare results to historical clinical outcomes rates

  4. Assay success across histologic subtypes and class of anti-cancer compounds [ Time Frame: 2 years ]
    Assay success rate

Biospecimen Retention:   Samples With DNA
Fresh tumor tissue

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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 therapies which are considered standard of care.

Inclusion Criteria:

  • Patient 18 years and older
  • Any patient with a diagnosis of or a suspected diagnosis of advanced cancer (ovarian, brain or other rare tumors) undergoing surgery or biopsy to remove tumor tissue
  • Must be considered a candidate for systemic therapy with cytotoxic chemotherapy, targeted small molecule inhibitors or immunotherapy
  • Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
  • Written informed consent in accordance with institutional standards must be obtained from patient or legal guardian

Exclusion Criteria:

  • Patient refusing or unable to sign informed consent
  • Patient who fails to have surgery or a biopsy as part of routine clinical practice
  • Patient who refuses 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 stable.
  • Patients unable or unwilling to receive 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 identifier (NCT number): NCT03561207

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United States, California
University of California San Francisco
San Francisco, California, United States, 94143
United States, New Jersey
Capital Health Institute for Neurosciences
Trenton, New Jersey, United States, 08638
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14203
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, South Carolina
Prisma Health
Greenville, South Carolina, United States, 29605
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
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Study Director: Cecile Rose T Vibat, PhD Kiyatec

Additional Information:
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Responsible Party: Kiyatec Identifier: NCT03561207    
Other Study ID Numbers: KIY-REG-001
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: September 2019
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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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue