Borderline Ovarian TumorNCT05791838
Experience in Borderline Ovarian Tumors
An observational study of Borderline Ovarian Tumor, run by University of Palermo.
Trial summary
Borderline ovarian tumors (BOTs) comprise 15-20% of primary ovarian neoplasms and represent an independent disease entity among epithelial ovarian cancers. The present study aimed to report the 8-year experience of a single center on the management and outcomes of consecutive BOTs patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Borderline Ovarian Tumor
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Mar 2023
- 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: Patients surgically treated for borderline ovarian tumors (BOT)
Who may be able to join
- Age > 18 years,
- Patients affected by borderline ovarian tumors (BOT) of any histological type and any FIGO stage,
- Women undergoing surgical treatment with both laparoscopic and laparotomic approaches.
Who cannot join
- Women affected by ovarian cancers
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Borderline Ovarian Tumors: Results of a Retrospective, Single-center Experience
Borderline ovarian tumors (BOTs) comprise 15-20% of primary ovarian neoplasms and represent an independent disease entity among epithelial ovarian cancers. The present study aimed to report the 8-year experience of a single center on the management and outcomes of consecutive BOTs patients. From January 2010 to December 2017, all patients with BOTs undergoing surgical treatment were included. Demographic, clinical, and pathological data were reviewed retrospectively.
- Conditions
- Borderline Ovarian Tumor
- Keywords
- Conservative surgery, Micropapillary patterns, Surgical staging
What is being measured
The primary outcome is the main question the study is designed to answer.
Oncological outcome
Patients who underwent surgery for BOT
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study startMar 2023 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Ovarian TumorStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Etrusco, University of Palermo
- Investigators
- Basilio Pecorino, M.D., Principal investigator, University of CataniaPaolo Scollo, M.D. Ph.D., Study director, University of CataniaAntonio Simone Laganà, M.D. Ph.D., Study chair, University of PalermoAndrea Etrusco, M.D., Study chair, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791838
- Sponsor's protocol ID
- BOT-1
- Status last verified
- Mar 2023
- First submitted
- 8 Feb 2023
- Last updated
- 30 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Borderline Ovarian Tumors: Results of a Retrospective, Single-center Experience
- ClinicalTrials.gov ID
- NCT05791838
- Acronym / sponsor ID
- BOT-1
- Conditions
- Borderline Ovarian Tumor
- Keywords
- Conservative surgery, Micropapillary patterns, Surgical staging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 30 Mar 2023 (actual)
- 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.
Borderline ovarian tumors (BOTs) comprise 15-20% of primary ovarian neoplasms and represent an independent disease entity among epithelial ovarian cancers. The present study aimed to report the 8-year experience of a single center on the management and outcomes of consecutive BOTs patients. From January 2010 to December 2017, all patients with BOTs undergoing surgical treatment were included. Demographic, clinical, and pathological data were reviewed retrospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients surgically treated for borderline ovarian tumors (BOT)
Key inclusion criteria (3 listed)
- Age > 18 years,
- Patients affected by borderline ovarian tumors (BOT) of any histological type and any FIGO stage,
- Women undergoing surgical treatment with both laparoscopic and laparotomic approaches.
Key exclusion criteria (1 listed)
- Women affected by ovarian cancers
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
Oncological outcome
Time frame: through study completion, an average of 1 year
Patients who underwent surgery for BOT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
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A Prospective Multicenter Diagnostic Biomarker Study to Discriminate Borderline From Stage I Invasive Ovarian Cancer
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Sub-type Specific Genomic Mutations in sBOTs
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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.
Basilio Pecorino, M.D. principal investigator
University of Catania
Paolo Scollo, M.D. Ph.D. study director
University of Catania
Antonio Simone Laganà, M.D. Ph.D. study chair
University of Palermo
Questions about this trial
What is this clinical trial studying?
An observational study of Borderline Ovarian Tumor, run by University of Palermo.
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 3 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 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Andrea Etrusco, M.D. (+393881715032, etruscoandrea@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oncological outcome (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2023.