Ovarian CancerChemoINtelNCT06844136
ChemoINTEL Assay Algorithm Development Study: In-Vitro Cytotoxic Drug Induced Apoptosis Correlation with Patient Clinical Response to Administered Chemotherapy in Patients
An observational study of Ovarian Cancer, run by Pierian Biosciences at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Nov 2023to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Ovarian cancer diagnosis
Who may be able to join
- 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
Show all 24Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Liverpool Women's NHS Foundation Trust
Liverpool, Merseyside, L8 7SS
Mohamed Mehasseb, MBBCh, MSc, MD, MRCOG, PhD, mohamed.mehasseb@lwh.nhs.uk
About this study
Official title: 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.
Read the 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
- Being tested
- No intervention
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | De Novo (no prior cytotoxic therapy) receiving primary cytoreductive surgery and adjuvant chemotherapy Receives: Other: No intervention | |
| Group 2 | De Novo (no prior cytotoxic therapy) receiving neoadjuvant chemotherapy and interval cytoreductive surgery followed by additional chemotherapy Receives: Other: No intervention | |
| Group 3 | Recurrent (one or more prior lines of previous cytotoxic therapy) receiving next line of chemotherapy Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction Algorithm
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start22 Nov 2023
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pierian Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Henry, Study director, Pierian Biosciences Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844136
- Sponsor's protocol ID
- 201600013
- Acronym
- ChemoINtel
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan to disseminate the findings and publish the findings, all data will be anonymised
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06844136
- Acronym / sponsor ID
- ChemoINtel / 201600013
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pierian BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: No interventionDe Novo (no prior cytotoxic therapy) receiving primary cytoreductive surgery and adjuvant chemotherapy |
| Group 2 | – | Other: No interventionDe Novo (no prior cytotoxic therapy) receiving neoadjuvant chemotherapy and interval cytoreductive surgery followed by additional chemotherapy |
| Group 3 | – | Other: No interventionRecurrent (one or more prior lines of previous cytotoxic therapy) receiving next line of chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ovarian cancer diagnosis
Key inclusion criteria (24 listed)
- Females ≥18 years of age
- Diagnosis by pathology of one of either advanced stage EOC, Primary Peritoneal Carcinomatosis, or Fallopian Tube Carcinoma
- 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
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Group 1, Group 2, Group 3 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No. Plan to disseminate the findings and publish the findings, all data will be anonymised
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Henry study director
Pierian Biosciences Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Pierian Biosciences at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Norman Purvis, PhD (+44 (0)333 034 1690, npurvis@pierianbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction Algorithm (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.