ONCOSYS-OVA: Systems Oncology Approach to Optimize Ovarian Cancer Treatment

Sponsor

University of Helsinki (Other)

Overall Status

Recruiting

CT.gov ID

NCT06117384

Collaborator

Helsinki University Central Hospital (Other)

500

Enrollment

Location

Anticipated Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Genetic: Biomolecular profiling

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Systems Oncology Approach to Optimize Ovarian Cancer Treatment

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2027

Anticipated Study Completion Date :

Dec 31, 2027

Outcome Measures

Primary Outcome Measures

Recruitment and collection of real-world clinical data from ovarian cancer patients [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.
Successful collection and translational analysis of biospecimens [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.

Secondary Outcome Measures

Discovery of candidate prognostic and predictive biomarkers [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients diagnosed with ovarian cancer
Available tumor tissue/blood samples

Exclusion Criteria:

Inability to consent to the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Helsinki University and Helsinki University Hospital	Helsinki		Finland	00014

Sponsors and Collaborators

University of Helsinki
Helsinki University Central Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anniina Färkkilä, Assistant Professor, Specialist in Gynecology, University of Helsinki

ClinicalTrials.gov Identifier:

NCT06117384

Other Study ID Numbers:

HUS33342021

First Posted:

Nov 7, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Study Results

No Results Posted as of Nov 7, 2023