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

Kiyatec

Status: Active, not recruiting

Conditions: Advanced Cancer; Glioblastoma Multiforme; Ovarian Cancer; Anaplastic Astrocytoma

Treatments: Diagnostic Test: EV3D Assay

Study type: Observational

Funder types: Industry

Identifiers

NCT03561207

KIY-REG-001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 570 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

570 participants in 1 patient group

Tumor tissue tested with EV3D Assay

Description:

Cancer tissue from multiple sites in the body, to include ovarian, brain, and other rare tumors.

Treatment:

Diagnostic Test: EV3D Assay