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

February 25, 2025 updated by: Pierian Biosciences

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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).

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L8 7SS
        • Recruiting
        • Liverpool Women's NHS Foundation Trust
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Ovarian cancer diagnosis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
De Novo (no prior cytotoxic therapy) receiving primary cytoreductive surgery and adjuvant chemotherapy
Other: No intervention
No intervention
Group 2
De Novo (no prior cytotoxic therapy) receiving neoadjuvant chemotherapy and interval cytoreductive surgery followed by additional chemotherapy
Other: No intervention
No intervention
Group 3
Recurrent (one or more prior lines of previous cytotoxic therapy) receiving next line of chemotherapy
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction Algorithm
Time Frame: 2 years
To develop a prediction algorithm that uses input from the ChemoINTEL and ImmunoINTEL assay metric results and provides an accurate prediction of a patient's cancer's sensitivity to specific chemotherapeutic agents by assessing the patient's response based on either RECIST criteria (v 1.1, 2009), CA-125 KELIM Score, and/or circulating tumor DNA changes to the administered chemotherapy following three cycles of SOC chemotherapy.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierian Biosciences

Investigators

  • Study Director: Robert Henry, Pierian Biosciences Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2023

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

February 19, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201600013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Plan to disseminate the findings and publish the findings, all data will be anonymised

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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