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Clinical Trials/NCT02758652
NCT02758652
Active, not recruiting
Not Applicable

Molecular Mechanisms Leading to Chemoresistance in Epithelial Ovarian Cancer

Tampere University Hospital1 site in 1 country160 target enrollmentMay 2016
ConditionsOvarian Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ovarian Cancer
Sponsor
Tampere University Hospital
Enrollment
160
Locations
1
Primary Endpoint
miRNA expression profile as measured by miRNA array
Status
Active, not recruiting
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
May 2026
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Annika Auranen

Chief in gynecological oncology

Tampere University Hospital

Eligibility Criteria

Inclusion Criteria

  • 18 years of age, informed consent.

Exclusion Criteria

  • Informed consent not provided, age under 18 years.

Outcomes

Primary Outcomes

miRNA expression profile as measured by miRNA array

Time Frame: 5 years

Expression profile calculated with bioinformatical analysis

Secondary Outcomes

  • Progression-free survival(5 years)
  • Over-all survival(5 years)

Study Sites (1)

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