Systems Oncology Approach to Optimize Ovarian Cancer Treatment

NCT06117384 | Recruiting

• 1 other identifier: HUS33342021
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Discovery of candidate prognostic and predictive biomarkers

  5 years

Interventions

Biomolecular profiling GENETIC

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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Inability to consent to the study

Sponsors & Collaborators

• University of Helsinki: lead
• Helsinki University Central Hospital: collaborator

Study Sites (1)

Helsinki University and Helsinki University Hospital

Helsinki, 00014, Finland

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Anniina Färkkilä, MD PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anniina Färkkilä, MD PhD

CONTACT

+358504272060; anniina.farkkila@helsinki.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Specialist in Gynecology

Study Record Dates

• First Submitted: October 21, 2023
• First Posted: November 7, 2023
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)