RecruitingNCT06844136

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

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.

Sponsor

Pierian Biosciences

Enrollment

100 participants

Start Date

Nov 22, 2023

Study Type

OBSERVATIONAL

Conditions

Ovarian Cancer

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria31

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
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 Criteria4

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