AzTrials
AzTrials

High Grade Ovarian Serous AdenocarcinomaDECIDERNCT04846933

Multi-layer Data to Improve Diagnosis, Predict Therapy Resistance and Suggest Targeted Therapies in HGSOC

A study testing WGS and RNA sequencing, circulating tumor DNA (ctDNA) and FDG PET/CT imaging in people with High Grade Ovarian Serous Adenocarcinoma and High Grade Serous Carcinoma, run by Turku University Hospital at 1 site in Finland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
WGS and RNA sequencing, circulating tumor DNA (ctDNA) and FDG PET/CT imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteFinland
Study dates
1 Feb 2012to Dec 2029
Phase
Interventional
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

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Johanna Hynninen contact

+358 50 5383554

johanna.hynninen@utu.fi

Sampsa Hautaniemi contact

+358503364765

sampsa.hautaniemi@helsinki.fi

Finland1 site, 1 recruiting

  • Turku University Hospital

    Turku, 20520

    Johanna Hynninen, 0505383554, johanna.hynninen@utu.fi

    Johanna Hynninen, MD, PhD

    Recruiting

Other trials in Finland

About this study

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

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.

Read the 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.
Being tested
WGS and RNA sequencing, circulating tumor DNA (ctDNA), FDG PET/CT imaging
Keywords
chemoresistance, personalized medicine, WGS, ctDNA, digital pathology, FDG PET/CT, bioinformatics, AI, ovarian cancer, tumor evolution, artificial intelligence, organoid, DNA methylation, radiomics
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WGS and RNA sequencingGenetic

  • circulating tumor DNA (ctDNA)Genetic

  • FDG PET/CT imagingDiagnostic test

Study groups in NCT04846933
Study groupRoleWhat they receive
HGSOC patients treated with Neoadjuvant chemotherapy (NACT)OtherDiagnostic laparoscopy followed with 3-4 cycles of platinum-taxane NACT and interval debulking surgery (IDS). Treatment response is monitored with FDG PET/CT. IDS is followed by standard adjuvant therapy (ESGO/ESMO + local guidelines). Digital H\&E slides and WGS, RNAseq are obtained from performed surgeries including relapse operations/ascites drainages. Patients are followed with longitudinal ctDNA sampling.
Receives: Genetic: WGS and RNA sequencing; Genetic: circulating tumor DNA (ctDNA); Diagnostic Test: FDG PET/CT imaging
HGSOC patients treated with primary debulking surgery (PDS)OtherPDS is followed by standard adjuvant therapy (ESGO/ESMO + local guidelines). Digital H\&E slides and WGS, RNAseq obtained from PDS and possible relapse operations/ascites drainages when performed. Patients are followed with longitudinal ctDNA sampling.
Receives: Genetic: WGS and RNA sequencing; Genetic: circulating tumor DNA (ctDNA); Diagnostic Test: FDG PET/CT imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful clinical translation

    The magnitude of successful clinical translation is measured by the number of times project-derived personalized medicine has impacted patients care by application of novel and existing biomarkers and therapies.

    Measured: 5 years

  2. Successful prediction of patient outcome with AI methods

    Proportion of patients whose disease outcome (PFS, OS) is predicted correctly with digital histopathology images, genomic data and routine laboratory values

    Measured: 5 years

Secondary outcomes (4)

  1. Successful validation of potentially druggable genetic alterations

    Number of potentially druggable genetic alterations found and validated with in-vitro methods

    Measured: 5 years

  2. Successful prediction of genomic features from tumor histology

    Number of genomic features that can be successfully recognized from tumor histology

    Measured: 5 years

  3. Prediction of primary treatment response from tumor histology using H&E stained whole slide images and AI-based methods

    Number of patients whose outcome (primary therapy outcome, PFS) is predicted correctly

    Measured: 5 years

  4. Establishment of an updated version of Chemoresponse score (CRS) for measuring histological effect in tumor tissue after chemotherapy

    Predictive power of the updated CRS at interval surgery is compared with traditional CRS

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2021
  2. Study start1 Feb 2012
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04846933
Sponsor's protocol ID
TO7/003/21
Other IDs
965193
Acronym
DECIDER
Status last verified
Jan 2025
First submitted
12 Apr 2021
Last updated
16 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Afenteva D, Yu R, Rajavuori A, Salvadores M, Launonen IM, Lavikka K, Zhang K, Pirttikoski A, Marchi G, Jamalzadeh S, Isoviita VM, Li Y, Micoli G, Erkan EP, Falco MM, Ungureanu D, Lahtinen A, Oikkonen J, Hietanen S, Vaharautio A, Sur I, Virtanen A, Farkkila A, Hynninen J, Muranen TA, Taipale J, Hautaniemi S. Multi-omics analysis reveals the attenuation of the interferon pathway as a driver of chemo-refractory ovarian cancer. Cell Rep Med. 2025 Sep 16;6(9):102316. doi: 10.1016/j.xcrm.2025.102316. Epub 2025 Aug 29.

    PubMed 40885189

  • Lahtinen A, Lavikka K, Virtanen A, Li Y, Jamalzadeh S, Skorda A, Lauridsen AR, Zhang K, Marchi G, Isoviita VM, Ariotta V, Lehtonen O, Muranen TA, Huhtinen K, Carpen O, Hietanen S, Senkowski W, Kallunki T, Hakkinen A, Hynninen J, Oikkonen J, Hautaniemi S. Evolutionary states and trajectories characterized by distinct pathways stratify patients with ovarian high grade serous carcinoma. Cancer Cell. 2023 Jun 12;41(6):1103-1117.e12. doi: 10.1016/j.ccell.2023.04.017. Epub 2023 May 18.

    PubMed 37207655

Questions about this trial

What is this clinical trial studying?

A study testing WGS and RNA sequencing, circulating tumor DNA (ctDNA) and FDG PET/CT imaging in people with High Grade Ovarian Serous Adenocarcinoma and High Grade Serous Carcinoma, run by Turku University Hospital at 1 site in Finland.

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 2 inclusion and 2 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 16 Jan 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 Finland. 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 Johanna Hynninen (+358 50 5383554, johanna.hynninen@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful clinical translation (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04846933, which also lists 2 linked publications.

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 16 Jan 2025; AzTrials last refreshed its copy on 29 Oct 2026.

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