Systems Oncology Approach to Optimize Ovarian Cancer Treatment

Ovarian Cancer Clinical Trial

— ONCOSYS-OVA  

Official title:

Systems Oncology Approach to Optimize Ovarian Cancer Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06117384
• Other study ID #: HUS33342021
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: November 2023
• Source: University of Helsinki
• Contact: Anniina Färkkilä, MD PhD
• Phone: +358504272060
• Email: anniina.farkkila[@]helsinki.fi
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with ovarian cancer

• Available tumor tissue/blood samples

Exclusion Criteria:

• Inability to consent to the study

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Genetic:
• Biomolecular profiling
Molecular and functional analysis of biospecimens, including tumor-normal Whole-exome sequencing, bulk and single-cell RNAsequencing, spatial proteomics, functional testing.

Locations

Country	Name	City	State
Finland	Helsinki University and Helsinki University Hospital	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
University of Helsinki	Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment and collection of real-world clinical data from ovarian cancer patients	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
Primary	Successful collection and translational analysis of biospecimens	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	Discovery of candidate prognostic and predictive biomarkers	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