ChemoINTEL Assay Algorithm Development Study: In-Vitro Cytotoxic Drug Induced Apoptosis Correlation with Patient Clinical Response to Administered Chemotherapy in Patients (ChemoINtel)
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.
Study Overview
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Norman Purvis, PhD
- Phone Number: +44 (0)333 034 1690
- Email: npurvis@pierianbio.com
Study Contact Backup
- Name: Maria Maguire, PhD
- Phone Number: 07824609720
- Email: maria.maguiire2@nhs.net
Study Locations
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Merseyside
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Liverpool, Merseyside, United Kingdom, L8 7SS
- Recruiting
- Liverpool Women's NHS Foundation Trust
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Contact:
- Mohamed Mehasseb, MBBCh, MSc, MD, MRCOG, PhD
- Email: mohamed.mehasseb@lwh.nhs.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Group 1
De Novo (no prior cytotoxic therapy) receiving primary cytoreductive surgery and adjuvant chemotherapy
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No intervention
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Group 2
De Novo (no prior cytotoxic therapy) receiving neoadjuvant chemotherapy and interval cytoreductive surgery followed by additional chemotherapy
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No intervention
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Group 3
Recurrent (one or more prior lines of previous cytotoxic therapy) receiving next line of chemotherapy
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No intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prediction Algorithm
Time Frame: 2 years
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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.
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2 years
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Robert Henry, Pierian Biosciences Ltd
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Neoplasms by Histologic Type
- Genital Diseases, Female
- Endocrine Gland Neoplasms
- Neoplasms, Glandular and Epithelial
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Carcinoma
- Carcinoma, Ovarian Epithelial
- Ovarian Neoplasms
Other Study ID Numbers
- 201600013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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