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NCT02758652 Clinical Trial

Molecular Mechanisms Leading to Chemoresistance in Epithelial Ovarian Cancer

Ovarian Cancer Clinical Trial

— CHEMOVA  

Official title:
Molecular Mechanisms Leading to Chemoresistance in Epithelial Ovarian Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02758652
Other study ID # R15134
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 2016
Est. completion date May 2026

Study information
Verified date June 2021
Source Tampere University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 160
Est. completion date May 2026
Est. primary completion date April 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years of age, informed consent. Exclusion Criteria: - Informed consent not provided, age under 18 years.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Finland Tampere University Hospital Tampere

Sponsors (3)
Lead Sponsor Collaborator
Tampere University Hospital Tampere University, University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary miRNA expression profile as measured by miRNA array Expression profile calculated with bioinformatical analysis 5 years
Secondary Progression-free survival Time from diagnosis to disease relapse 5 years
Secondary Over-all survival Timo from diagnosis to death 5 years
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