NCT06844136Recruiting
ChemoINTEL Assay Algorithm Development Study: In-Vitro Cytotoxic Drug Induced Apoptosis Correlation with Patient Clinical Response to Administered Chemotherapy in 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.
Source: ClinicalTrials.gov · Last updated 28 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 19 Feb 2025
- Start date
- 22 Nov 2023
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Pierian Biosciences
- Diseases
- Ovarian cancer
- NCT number
- NCT06844136
What you commit to
- Study type: Observational
- Planned participants: 100
- From 22 Nov 2023 to the primary completion date, 31 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Patient has a cancer other than advanced stage EOC
Other
- Patient has not signed an ICF to participate in a clinical investigation
Who the study is looking for
- 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
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Liverpool Women's NHS Foundation Trust Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.