ChemoINTEL Assay Algorithm Development Study: In-Vitro Cytotoxic Drug Induced Apoptosis Correlation with Patient Clinical Response to Administered Chemotherapy in Patients
NCT ID: NCT06844136
Last Updated: 2025-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2023-11-22
2027-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group 1
De Novo (no prior cytotoxic therapy) receiving primary cytoreductive surgery and adjuvant chemotherapy
No intervention
No intervention
Group 2
De Novo (no prior cytotoxic therapy) receiving neoadjuvant chemotherapy and interval cytoreductive surgery followed by additional chemotherapy
No intervention
No intervention
Group 3
Recurrent (one or more prior lines of previous cytotoxic therapy) receiving next line of chemotherapy
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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Pierian Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Henry
Role: STUDY_DIRECTOR
Pierian Biosciences Ltd
Locations
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Liverpool Women's NHS Foundation Trust
Liverpool, Merseyside, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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201600013
Identifier Type: -
Identifier Source: org_study_id
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