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

• ClinicalTrials.gov Identifier: NCT03561207
• Recruitment Status: Enrolling by invitation
• First Posted: June 19, 2018
• Last Update Posted: September 11, 2019
• 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: September 11, 2019
• Actual Study Start Date: June 11, 2018
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Current 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

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03561207 on ClinicalTrials.gov Archive Site

Current 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

• Original Secondary Outcome Measures: Same as current
• 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 and Glioblastoma multiforme.
• 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).
• 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 therapies which are considered standard of care.

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: Enrolling by invitation
• Estimated Enrollment (submitted: October 3, 2018): 570
• Original Estimated Enrollment (submitted: June 10, 2018): 640
• Estimated Study Completion Date: June 2022
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Eligibility 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 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• 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: Charlene Knape; Kiyatec

• PRS Account: Kiyatec
• Verification Date: September 2019