Developing a predictive algorithm for chemotherapy response in ovarian cancer 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.
This study is testing a new way to predict how well chemotherapy will work for people with advanced ovarian cancer by looking at their tumor and blood samples to create personalized treatment plans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Pierian Biosciences Industry-sponsored |
| Drugs / interventions | Bevacizumab, chemotherapy, Cyclophosphamide, Doxorubicin |
| Locations | 1 site (Liverpool, Merseyside) |
| Trial ID | NCT06844136 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a mathematical algorithm that predicts the sensitivity of advanced stage epithelial ovarian cancer (EOC) tumors to specific chemotherapy drugs. By utilizing ChemoINTEL and ImmunoINTEL assay measurements from tumor biopsies and matched blood samples, the study will correlate these assay results with patient clinical responses to chemotherapy. The goal is to create a personalized treatment plan based on individual tumor characteristics, moving beyond traditional guideline-driven approaches. The study will also collect medical history and pathology information to enhance the predictive accuracy of the algorithm.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 and older with advanced stage epithelial ovarian cancer, primary peritoneal carcinomatosis, or advanced stage fallopian tube carcinoma.
Not a fit: Patients who are not newly diagnosed or recurrent cases of the specified cancers, or those who cannot provide evaluable tumor specimens, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enable personalized chemotherapy regimens that improve treatment outcomes for ovarian cancer patients.
How similar studies have performed: While similar predictive algorithms have been explored in oncology, this specific approach using ChemoINTEL and ImmunoINTEL assays in ovarian cancer is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Liverpool, Merseyside
- Liverpool Women's NHS Foundation Trust — Liverpool, Merseyside, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Norman Purvis, PhD
- Email: npurvis@pierianbio.com
- Phone: +44 (0)333 034 1690
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.