Molecular Mechanisms Leading to Chemoresistance in Epithelial Ovarian Cancer

Active, not recruiting

• Conditions: Ovarian Cancer

• Registration Number: NCT02758652
• Lead Sponsor: Tampere University Hospital

Brief Summary

Epithelial ovarian cancer is the most lethal gynecological malignancy in developed countries and the fifth most common cause of cancer-related death in women. Poor prognosis is due to challenges in early diagnosis and development of inevitable resistance to chemotherapy in majority of patients despite of good initial treatment response. The purpose of this prospective study is to analyze variation in microRNA expression in prediction of primary treatment response and the role of microRNAs in development of chemoresistance in epithelial ovarian cancer.

• Objectives: To screen microRNAs from prospectively collected plasma, urine and tumor samples from patients diagnosed with epithelial ovarian cancer. Samples are analyzed for microRNA expression and differential expression is correlated with primary treatment response, progression-free survival and overall survival.

• Methods: Plasma, urine and tumor samples are collected at primary surgery (open surgery or diagnostic laparoscopy) or interval debulking surgery, at 1st, 3rd and 6th neoadjuvant or adjuvant chemotherapy and at progression for high-throughput screening of microRNA expression by array technology.

Detailed Description

Inclusion criteria:

patients operated for a suspected ovarian malignancy in the Department of Obstetrics and Gynecology in Tampere University Informed consent obtained

Study Timeline

• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-28
• Study Start: 2016-05
• Study First Posted: 2016-05-02
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-21
• Last Update Posted: 2021-06-22
• Primary Completion: 2026-04
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

• 18 years of age, informed consent.

Exclusion Criteria

• Informed consent not provided, age under 18 years.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
miRNA expression profile as measured by miRNA array	5 years	Expression profile calculated with bioinformatical analysis

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	5 years	Time from diagnosis to disease relapse
Over-all survival	5 years	Timo from diagnosis to death

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland