Ovarian CancerCHEMOVANCT02758652
Molecular Mechanisms Leading to Chemoresistance in Epithelial Ovarian Cancer
An observational study of Ovarian Cancer, run by Tampere University Hospital at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 160 participants
- Where
- 1 siteFinland
- Study dates
- May 2016to May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed epithelial ovarian cancer patients operated inTampere University Hospital, Finland.
Who may be able to join
- 18 years of age, informed consent.
Who cannot join
- Informed consent not provided, age under 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Inclusion criteria:
patients operated for a suspected ovarian malignancy in the Department of Obstetrics and Gynecology in Tampere University Informed consent obtained
- Conditions
- Ovarian Cancer
- Keywords
- chemoresistance, miRNA, microRNA
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
miRNA expression profile as measured by miRNA array
Expression profile calculated with bioinformatical analysis
Measured: 5 years
Secondary outcomes (2)
Progression-free survival
Time from diagnosis to disease relapse
Measured: 5 years
Over-all survival
Timo from diagnosis to death
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startMay 2016
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, University of Helsinki
- Responsible party
- Principal investigator, Annika Auranen, Tampere University Hospital
- Investigators
- Annika Auranen, adj prof, Principal investigator, Chief of Gynecological Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758652
- Sponsor's protocol ID
- R15134
- Acronym
- CHEMOVA
- Status last verified
- Jun 2021
- First submitted
- 5 Apr 2016
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32611374
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Mechanisms Leading to Chemoresistance in Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT02758652
- Acronym / sponsor ID
- CHEMOVA / R15134
- Conditions
- Ovarian Cancer
- Keywords
- chemoresistance, miRNA, microRNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University, University of Helsinki
- Study start
- May 2016
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 2 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed epithelial ovarian cancer patients operated inTampere University Hospital, Finland.
Key inclusion criteria (1 listed)
- 18 years of age, informed consent.
Key exclusion criteria (1 listed)
- Informed consent not provided, age under 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
miRNA expression profile as measured by miRNA array
Time frame: 5 years
Expression profile calculated with bioinformatical analysis
2 secondary outcomes
Progression-free survival
Time frame: 5 years
Over-all survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Derived from this study: PubMed 32611374Savolainen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annika Auranen, adj prof principal investigator
Chief of Gynecological Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
miRNA expression profile as measured by miRNA array (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02758652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.