ChemoINTEL Assay Algorithm Development Study: In-Vitro Cytotoxic Drug Induced Apoptosis Co
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 pat
| Condition(s) | Ovarian Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 surgic |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Pierian Biosciences |
| Locations | Liverpool, Merseyside, United Kingdom |
| Start date | 2023-11-22 |
| NCT ID | NCT06844136 |
| Official listing | https://clinicaltrials.gov/study/NCT06844136 |