Molecular Mechanisms Leading to Chemoresistance in Epithe... | NCT02758652

Studies
Molecular Mechanisms Leading to Chemoresistance in Epithelial Ovarian Cancer

NCT02758652

Sponsor

Tampere University Hospital

Status

Unknown status

Last Update Posted

Jun 22, 2021Actual

Enrollment

160Actual

Phase

Not provided

Conditions

Ovarian Cancer

Interventions

Not provided

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

Apr 2026Estimated

Completion Date

May 2026Estimated

First Submitted Date

Apr 5, 2016

First Submission Date that Met QC Criteria

Apr 28, 2016

First Posted Date

May 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2021

Last Update Posted Date

Jun 22, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Annika Auranen, Chief in gynecological oncology, Tampere University HospitalPrincipal Investigator

Lead Sponsor

Tampere University HospitalOTHER

Collaborators

Name	Class
Tampere University	OTHER
University of Helsinki	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

160Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age, informed consent.

Exclusion Criteria:

Informed consent not provided, age under 18 years.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Annika Auranen, adj prof	Chief of Gynecological Oncology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tampere University Hospital		Tampere		33521	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32611374	Derived	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.

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases