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

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ClinicalTrials.gov Identifier: NCT03561207
Recruitment Status : Enrolling by invitation
First Posted : June 19, 2018
Last Update Posted : October 5, 2018
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 guiding therapy in patients with advanced cancers.

Condition or disease Intervention/treatment
Cancer, Advanced 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 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 in 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).

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, breast and other rare tumors.
Diagnostic Test: EV3D Assay
The EV3D assay uses freshly obtained tumor specimen to predict 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


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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 elective 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.
Criteria

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 elective 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 ClinicalTrials.gov identifier (NCT number): NCT03561207


Locations
United States, South Carolina
KIYATEC
Greenville, South Carolina, United States, 29605
Sponsors and Collaborators
Kiyatec
Investigators
Study Director: Charlene Knape KIYATEC, Inc.

Responsible Party: Kiyatec
ClinicalTrials.gov Identifier: NCT03561207     History of Changes
Other Study ID Numbers: KIY-REG-001
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No