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Molecular Mechanisms Leading to Chemoresistance in Epithelial Ovarian Cancer (CHEMOVA)

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ClinicalTrials.gov Identifier: NCT02758652
Recruitment Status : Recruiting
First Posted : May 2, 2016
Last Update Posted : September 18, 2019
Sponsor:
Collaborators:
Tampere University
Helsinki University
Information provided by (Responsible Party):
Annika Auranen, Tampere University Hospital

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.


Condition or disease
Ovarian Cancer

Detailed Description:

Inclusion criteria:

patients operated for a suspected ovarian malignancy in the Department of Obstetrics and Gynecology in Tampere University Informed consent obtained


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Molecular Mechanisms Leading to Chemoresistance in Epithelial Ovarian Cancer
Study Start Date : May 2016
Estimated Primary Completion Date : April 2026
Estimated Study Completion Date : May 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer




Primary Outcome Measures :
  1. miRNA expression profile as measured by miRNA array [ Time Frame: 5 years ]
    Expression profile calculated with bioinformatical analysis


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 5 years ]
    Time from diagnosis to disease relapse

  2. Over-all survival [ Time Frame: 5 years ]
    Timo from diagnosis to death


Biospecimen Retention:   Samples With DNA
Plasma, urine and tissue samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed epithelial ovarian cancer patients operated inTampere University Hospital, Finland.
Criteria

Inclusion Criteria:

  • 18 years of age, informed consent.

Exclusion Criteria:

  • Informed consent not provided, age under 18 years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758652


Contacts
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Contact: Annika Auranen, adj prof +358331164650 annika.auranen@pshp.fi
Contact: Kalle Savolainen, MD,PhD kalle.savolainen@pshp.fi

Locations
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Finland
Tampere University Hospital Recruiting
Tampere, Finland, 33521
Contact: Annika Auranen, Adj prof    +358331164650    annika.auranen@pshp.fi   
Contact: Kalle Savolainen, MD,PhD       kalle.savolainen@pshp.fi   
Sponsors and Collaborators
Tampere University Hospital
Tampere University
Helsinki University
Investigators
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Principal Investigator: Annika Auranen, adj prof Chief of Gynecological Oncology

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Responsible Party: Annika Auranen, Chief in gynecological oncology, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT02758652     History of Changes
Other Study ID Numbers: R15134
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Annika Auranen, Tampere University Hospital:
chemoresistance
miRNA
microRNA
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma