ChemoINTEL Assay Algorithm Development Study: In-Vitro Cytotoxic Drug Induced Apoptosis Correlation with Patient Clinical Response to Administered Chemotherapy in Patients

Summary

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.

Eligibility

Screening Criteria:

* Females ≥18 years of age
* Patient must sign an Informed Consent Form
* Patient is suspected to have one of the following

  * advanced stage Epithelial Ovarian Cancer (EOC)
  * advanced stage Primary Peritoneal Carcinomatosis
  * advanced stage Fallopian Tube Carcinoma

Inclusion Criteria:

* 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

Exclusion Criteria:

* Patient has not signed an ICF to participate in a clinical investigation
* Patient has a cancer other than advanced stage EOC
* Patient did NOT receive SOC chemotherapy, single agents or combination treatment from the indicated list above.
* Patients did NOT have sufficient viable cells recovered from either a fresh tumor dissociation or peritoneal fluid specimen collected prior to initiating chemotherapy available for the minimum ChemoINTEL assay analysis of Carboplatin, Cisplatin, Docetaxel, and Paclitaxel test conditions

Conditions2

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