NCT06844136

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.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Pierian Biosciences · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The justification for this study is to provide evidence based predictive scoring of available cytotoxic drug based on the patient's own tumour response characteristics to guide the physician's therapeutic selections and enable a personalized treatment plan. This study will generate a predictive algorithm using individual patient tumour ChemoINTEL and ImmunoINTEL assay response metrics paired with the patient's clinical response data. Subsequent Clinical Validation and Clinical Utility Studies will be conducted to provide further evidence for utilization of personalized predictive response scoring of available therapeutics enabling section of personalized treatment regiments based on each patient's unique tumour as an improvement over guideline driven approaches. Cancer treatments and selection of cytotoxic drugs used in different situations continues to be guideline driven. These selections are generally based on treatment protocols developed as a result of large, population-based, prospective, randomized, multicenter, well-controlled phase 3 studies that analyze treatment outcomes (progression-free survival \[PFS\] and overall survival \[OS\]) as a function of treatment received by patient cohorts. This approach was necessitated by the stark reality that no "predictive" or "treatment-directing" diagnostic technologies were available, a circumstance that, to an overwhelming degree, remains unaltered. Treatment "guidelines" are utilized by most oncologists globally as they recommend treatment algorithms and options based on data with the highest levels of evidence. Several treatment guidelines are available globally such as those produced by the National Comprehensive Cancer Network (NCCN), the American Society of Clinical Oncology (ASCO), and European Society of Medical Oncology (ESMO). These guidelines provide evidence-based recommendations to guide physicians and outline appropriate methods of treatment and care. The guidelines often address specific clinical situations (disease oriented) on the use of approved medical products, procedures, or tests (modality oriented).

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
OTHER	No intervention	No intervention

Timeline

• Start date: 2023-11-22
• Primary completion: 2026-07-31
• Completion: 2027-07-31
• First posted: 2025-02-25
• Last updated: 2025-02-28

Locations

1 site across 1 country: United Kingdom