ChemoINTEL Assay Algorithm Development Study: In-Vitro Cytotoxic Drug Induced Apoptosis Correlation with Patient Clinical Response to Administered Chemotherapy in Patients with Advanced Stage Epithelial Ovarian Cancer.
This is a prospective, non-randomized, observational, clinical development study. Pierian Biosciences is utilizing ChemoINTEL and ImmunoINTEL assay measurements in human tumour cells from patients with advanced stage epithelial ovarian cancer (EOC) to develop a mathematical algorithm which will be able to predict a patient's tumour's sensitivity to specific chemotherapy drugs. The study involves using a sample of tumour biopsy taken during standard of care surgery, with a matched blood sample if possible. Medical history, pathology information and information on chemotherapy for up to 6 cycles will be requested. The information will then be used to developed an algorithm to predict tumour sensitivity to treatment.
• Females ≥18 years of age
• Diagnosis by pathology of one of either advanced stage EOC, Primary Peritoneal Carcinomatosis, or Fallopian Tube Carcinoma
‣ Newly diagnosed
⁃ Recurrent
• Patient provided an evaluable tumor or peritoneal fluid specimen prior to initiating chemotherapy for ChemoINTEL assay analysis
• Patient received at least 3 cycles of standard of care chemotherapy for advanced stage EOC with single agent or combination of drugs summarised as below, following biopsy OR surgical resection
‣ Carboplatin
⁃ Cisplatin
⁃ Cyclophosphamide-4HC active metabolite
⁃ Docetaxel
⁃ Doxorubicin
⁃ Etoposide
⁃ Fluorouracil
⁃ Gemcitabine
⁃ Ifosfamide-4HI active metabolite
⁃ Irinotecan
⁃ Oxaliplatin
⁃ Paclitaxel
⁃ Pemetrexed
⁃ Topotecan
⁃ Vinorelbine
⁃ Bevacizumab (Avastin)
• Patients will have an appropriate evaluation after their third cycle and sixth cycle of SOC chemotherapy to document response by either RECIST 2009 v1.1, CA-125 KELIM Scoring, and/or circulating tumor DNA longitudinal monitoring
• Patient signed Informed Consent Form