NCT04846933 Multi-layer Data to Improve Diagnosis, Predict Therapy Resistance and Suggest Targeted Therapies in HGSOC
| NCT ID | NCT04846933 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Turku University Hospital |
| Condition | High Grade Ovarian Serous Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2012-02-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2012-02-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Sampsa Hautaniemi, DTech, Prof
STUDY DIRECTOR
University of Helsinki
Frequently Asked Questions
Who can join the NCT04846933 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying High Grade Ovarian Serous Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04846933 currently recruiting?
Yes, NCT04846933 is actively recruiting participants. Contact the research team at johanna.hynninen@utu.fi for enrollment information.
Where is the NCT04846933 trial being conducted?
This trial is being conducted at Turku, Finland.
Who is sponsoring the NCT04846933 clinical trial?
NCT04846933 is sponsored by Turku University Hospital. The principal investigator is Sampsa Hautaniemi, DTech, Prof at University of Helsinki. The trial plans to enroll 200 participants.