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

• ClinicalTrials.gov Identifier: NCT03561207
• Recruitment Status: Recruiting
• First Posted: June 19, 2018
• Last Update Posted: December 17, 2020
• Sponsor: KIYATEC
• Information provided by (Responsible Party): KIYATEC

Tracking Information

• 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 (submitted: May 12, 2020)

Establish correlation of Assay results with patient outcomes [ Time Frame: 2 year ]

Compare Assay results to reported patient outcomes

Original Primary Outcome Measures (submitted: June 10, 2018)

• Establish correlation of Assay results with patient outcomes [ Time Frame: 2 year ]
  Comparison to reported patient outcomes
• 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

Current Secondary Outcome Measures (submitted: May 13, 2020)

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

Original Secondary Outcome Measures (submitted: June 10, 2018)

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

• 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
• Target Follow-Up Duration: 2 Years

Biospecimen

Retention:   Samples With DNA

Description:

Fresh tumor tissue

• 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

• Advanced Cancer
• Ovarian Cancer
• Glioblastoma Multiforme
• Anaplastic Astrocytoma

Intervention

Diagnostic Test: EV3D Assay

The EV3D assay uses freshly obtained tumor specimen to predict tissue drug response.

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

• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 3, 2018): 570
• Original Estimated Enrollment (submitted: June 10, 2018): 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:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03561207
• Other Study ID Numbers: KIY-REG-001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: KIYATEC
• Study Sponsor: KIYATEC
• Collaborators: Not Provided

Investigators

• Study Director: Cecile Rose T Vibat, PhD; KIYATEC

• PRS Account: KIYATEC
• Verification Date: December 2020