Official Title
Integration of Multiple Data Levels to Improve Diagnosis, Predict Treatment Response and Suggest Targets to Overcome Therapy Resistance in High-grade Serous Ovarian Cancer
Brief Title
Multi-layer Data to Improve Diagnosis, Predict Therapy Resistance and Suggest Targeted Therapies in HGSOC
Protocol ID
NCT04846933
Lead Sponsor
Turku University Hospital
Brief Summary
Chemotherapy resistance is the greatest contributor to mortality in advanced cancers and
severe challenges remain in finding effective treatment modalities to cancer patients
with metastasized and relapsed disease. High-grade serous ovarian cancer (HGSOC) is
typically diagnosed at a stage where the disease is already widely spread to the abdomen
and current standard of practice treatment consists of surgery followed by
platinum-taxane based chemotherapy and maintenance therapy. While 90% of HGSOC patients
show no clinically detectable signs of cancer after surgery and chemotherapy, only 43% of
the patients are alive five years after diagnosis because of chemoresistant cancer.
This prospective, observational trial focuses on revealing major mechanisms causing
chemoresistance in HGSOG patients and derive personalized treatment regimens for
chemotherapy resistant HGSOC patients. The investigators recruit newly diagnosed advanced
stage HGSOC patients who are then thoroughly followed during their cancer treatment.
Longitudinal sampling includes digitalized H&E stained histology slides mainly collected
during routine diagnostics, fresh tumor & ascites samples for next-generation
sequencing/proteomics (WGS, RNA-seq, DNA-methylation, ATAC-seq, ChIP-seq, mass cytometry,
etc.) and ex vivo experiments, plasma samples for circulating tumor DNA (ctDNA) analyses.
Broad range of clinical parameters such as laboratory and radiologic parameters (e.g.,
FDG PET/CT), given cancer treatments and their outcomes are collected. Radiomic analyses
are performed to PET/CT and CT scans. Long-term patient derived organoid lines are
established from fresh tumor tissues. Actionable genomic alterations are searched.
The general objective is to establish a clinically useful precision oncology approach
based on multi-level data collected in longitudinal setting, and translate the most
potent and validated discoveries into clinical use. DECIDER project will produce
AI-powered diagnostic tools, cutting-edge software platforms for clinical
decision-making, novel data analysis & integration methods, and high-throughput ex vivo
drug screening approaches.
Detailed Description
Specific aims include:
- Develop tools and methods for personalized medicine approaches to cancer patients.
- Develop open-source visualization and interpretation software that facilitate
clinical decision making via data integration and interpretation of multilevel data
from cancer patients.
- Rapidly identify HGSOC patients who are likely to respond poorly to current
therapies combining information on digitalized histopathology samples, genomic and
clinical data with AI methods.
- Deploy validated personalized medicine treatment options using longitudinal
measurement and ex vivo organoid cultures from cancer patients in clinical care.
Study Period
Enrollment Count
200 participants
Eligibility Criteria
Inclusion Criteria:
- Patients with a suspected ovarian cancer diagnosis treated at the Turku University
Hospital
- Ability to understand and the willingness to sign a written informed consent
document
Exclusion Criteria:
- Age <18 years, too poor condition for active treatment (surgery, chemotherapy)
- FDG PET/CT scan is not performed for patients with diabetes mellitus and poor
glucose balance.
Filters
High Grade Ovarian Serous Adenocarcinoma
High Grade Serous Carcinoma
NA
RECRUITING
ADULT
OLDER_ADULT