Molecular Mechanisms Leading to Chemoresistance in Epithelial Ovarian Cancer

NCT02758652 | Active Not Recruiting

• 1 other identifier: R15134
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

chemoresistance; miRNA; microRNA

Outcome Measures

Primary Outcomes (1)

• miRNA expression profile as measured by miRNA array

  Expression profile calculated with bioinformatical analysis

  5 years

Secondary Outcomes (2)

• Progression-free survival

  5 years

• Over-all survival

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed epithelial ovarian cancer patients operated inTampere University Hospital, Finland.

You may qualify if:

• years of age, informed consent.

You may not qualify if:

• Informed consent not provided, age under 18 years.

Sponsors & Collaborators

• Tampere University Hospital: lead
• Tampere University: collaborator
• University of Helsinki: collaborator

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

Location

Related Publications (1)

• Savolainen K, Scaravilli M, Ilvesmaki A, Staff S, Tolonen T, Maenpaa JU, Visakorpi T, Auranen A. Expression of the miR-200 family in tumor tissue, plasma and urine of epithelial ovarian cancer patients in comparison to benign counterparts. BMC Res Notes. 2020 Jul 1;13(1):311. doi: 10.1186/s13104-020-05155-6.

  PMID: 32611374 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, urine and tissue samples

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Annika Auranen, adj prof

  Chief of Gynecological Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief in gynecological oncology

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: May 2, 2016
• Study Start: May 1, 2016
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 22, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)