Clinical trial

Integration of Multiple Data Levels to Improve Diagnosis, Predict Treatment Response and Suggest Targets to Overcome Therapy Resistance in High-grade Serous Ovarian Cancer

Name
TO7/003/21
Description
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, 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. 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.
Trial arms
Trial start
2012-02-01
Estimated PCD
2027-12-01
Trial end
2029-12-01
Status
Recruiting
Treatment
WGS and RNA sequencing
Arms:
HGSOC patients treated with Neoadjuvant chemotherapy (NACT), HGSOC patients treated with primary debulking surgery (PDS)
circulating tumor DNA (ctDNA)
Arms:
HGSOC patients treated with Neoadjuvant chemotherapy (NACT), HGSOC patients treated with primary debulking surgery (PDS)
FDG PET/CT imaging
Arms:
HGSOC patients treated with Neoadjuvant chemotherapy (NACT)
Size
200
Primary endpoint
Successful clinical translation
5 years
Successful prediction of patient outcome with AI methods
5 years
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tumor tissue (Fresh frozen tissue, FFPE), Whole blood samples, plasma, white cells'}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2023-06-18

1 organization

2 products

2 indications