💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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