Systems Oncology Approach to Optimize Ovarian Cancer Treatment (ONCOSYS-OVA)

November 1, 2023 updated by: Anniina Färkkilä, University of Helsinki
The overall aim is to identify effective therapeutic strategies to ovarian cancer (OC) using serial tumor, ascites and blood samples, and carry out state-of-the-art sequencing approaches, functional assays and associated bioinformatics to understand mechanisms behind chemoresistance in OC and identify new treatment options for OC patients. In this observational trial, we will systematically collect, analyze and interpret functional, molecular and clinical data from real-world ovarian cancer patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
      • Helsinki, Finland, 00014
        • Recruiting
        • Helsinki University and Helsinki University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All ovarian cancer patients who give their informed consent to the study.

Description

Inclusion Criteria:

  • Patients diagnosed with ovarian cancer
  • Available tumor tissue/blood samples

Exclusion Criteria:

  • Inability to consent to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment and collection of real-world clinical data from ovarian cancer patients
Time Frame: 5 years
Prospective recruitment and collection of clinical data from 500 ovarian cancer patients. Fraction of patients from which the collection of clinical data including patient age, tumor stage, histological diagnoses have been collected.
5 years
Successful collection and translational analysis of biospecimens
Time Frame: 5 years
Fraction of the recruited patients, from which tumor, ascites, and/or peripheral blood samples that have been successfully collected and subjected to molecular profiling.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discovery of candidate prognostic and predictive biomarkers
Time Frame: 5 years
Number of clinical and/or molecular features which of statistically significantly correlate to patient treatment outcomes (response to chemotherapy by RECIST1.1, Progression Free survival, Overall Survival).
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Anniina Färkkilä, MD PhD, Helsinki University Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

October 21, 2023

First Submitted That Met QC Criteria

November 1, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUS33342021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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