Molecular Mechanisms Leading to Chemoresistance in Epithelial Ovarian Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02758652

Acronym

CHEMOVA

Enrollment

160

Registered

2016-05-02

Start date

2016-05-31

Completion date

2026-05-31

Last updated

2021-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

chemoresistance, miRNA, microRNA

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 years of age, informed consent.

Exclusion criteria

* Informed consent not provided, age under 18 years.

Design outcomes

Primary

Measure	Time frame	Description
miRNA expression profile as measured by miRNA array	5 years	Expression profile calculated with bioinformatical analysis

Secondary

Measure	Time frame	Description
Progression-free survival	5 years	Time from diagnosis to disease relapse
Over-all survival	5 years	Timo from diagnosis to death

Countries

Finland

Outcome results