Molecular Mechanisms Leading to Chemoresistance in Epithelial Ovarian Cancer

NCT02758652Active, Not RecruitingOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Tampere University Hospital

Enrollment

160

Start Date

2016-05-01

Completion Date

2026-04-01

Study Type

OBSERVATIONAL

Official Title

Molecular Mechanisms Leading to Chemoresistance in Epithelial Ovarian Cancer

Conditions

Ovarian Cancer

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* 18 years of age, informed consent.

Exclusion Criteria:

* Informed consent not provided, age under 18 years.

Outcome Measures

Primary Outcomes

miRNA expression profile as measured by miRNA array

Expression profile calculated with bioinformatical analysis

Time frame: 5 years

Secondary Outcomes

Progression-free survival

Time from diagnosis to disease relapse

Time frame: 5 years

Over-all survival

Timo from diagnosis to death

Time frame: 5 years

Locations

Tampere University Hospital, Tampere, Finland

Linked Papers

2020-07-01

Expression of the miR-200 family in tumor tissue, plasma and urine of epithelial ovarian cancer patients in comparison to benign counterparts

Abstract Objective Plasma, but also urine sample could represent a simple liquid biopsy for ovarian cancer biomarker detection. The miRNA-200 family has been shown to be dysregulated in ovarian cancer. The aim of this study was to isolate three members of miR-200 family from tumor tissue, plasma and urine of high-grade serous ovarian cancer patients in comparison with samples from patients with benign ovarian tumors. This is a methodological pilot study of a prospective ovarian cancer patient cohort investigating the potential of liquid biopsies and the role of miRNAs in ovarian cancer treatment. Results MiR-200a, miR-200b and miR-200c were isolated from samples of nine ovarian cancer patients and seven patients with benign ovarian tumor. The most significant finding is that all three miRNAs were detectable in all sample types. Tumor tissue and plasma, but not urine analysis was able to discriminate malignant and benign samples. A correlation between the miRNA-200 expression in urine and plasma was observed in malignant samples only. Plasma and urine with respect to miRNA detection show potential according to this study, but larger studies are needed to clarify the usefulness of these liquid biopsies in ovarian cancer. Trial registration: ClinicalTrials.gov NCT02758652, May 2, 2016.

Linked Investigators

Kalle Savolainen

Molecular Mechanisms Leading to Chemoresistance in Epithelial Ovarian Cancer