HysterectomyNCT06825468
Role of Hysterectomy in the Treatment of Borderline Ovarian Tumors
An observational study of Hysterectomy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 3 sites in Italy.
Trial summary
Borderline ovarian tumors (BOT), are rare epithelial ovarian tumors characterized by the presence of frankly malignant cytologic features in the absence of stromal invasion. Surgical treatment of perimenopausal and postmenopausal BOT requires bilateral adnexectomy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hysterectomy
- How many people
- 168 participants
- Where
- 3 sitesItaly
- Study dates
- 10 Jan 2022to 31 Jan 2025
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with BOT diagnosis will be included in the study for analysis: * BSO and hysterectomy (group 1) * BSO without hysterectomy (group 2)
Who may be able to join
- Women in menopause clinically defined as absence of menstrual cycle for 12 months
- Primary diagnosis of BOT confirmed by pathological examination
- Surgical treatment of BOT by BSO with (group 1) and without (group 2) hysterectomy
- Informed consent acquisition
Who cannot join
- Occurrence of BOT at index intervention
- Stage IV
- Metastatic disease
- Patients with previous hysterectomy
- Cancer synchronous of the endometrium
- Patients who have not had follow-up before 5 years (excluding those who have not reached the 5 year follow-up for the following events: death from any cause, death from BOT, recurrence of BOT)
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Roma, 00136
Ospedale universitario, Azienda Sanitaria Universitaria Friuli Centrale
Udine, 33100
About this study
Official title: Role Of Hysterectomy In The Treatment Of Borderline Ovarian Tumors
Borderline ovarian tumors (BOT), are rare epithelial ovarian tumors characterized by the presence of frankly malignant cytologic features in the absence of stromal invasion.
Surgical treatment of perimenopausal and postmenopausal BOT requires bilateral adnexectomy. Although some studies have reported an increased recurrence rate in the group of patients treated with uterine preservation, these data are severely limited by the small sample of patients and the presence of confounding factors in the analysis of oncologic outcomes.
Determining the impact of hysterectomy on the survival outcomes of perimenopausal and postmenopausal patients diagnosed with early FIGO stage BOT is necessary to avoid overtreatment, hysterectomy being associated with a low but not negligible rate of morbidity and mortality.
Read the detailed description
Borderline ovarian tumors (BOTs), are rare epithelial ovarian tumors characterized by the presence of frankly malignant cytologic features in the absence of stromal invasion. Serous BOTs, which account for 67% of all BOTs, are limited to one ovary in 75% of cases and are frequently accompanied by predominantly noninvasive peritoneal implants. In 30% of cases, BOTs are mucinous, unilateral, and characterized by a low rate of extra-ovarian spread and invasive implants. Patients with BOT are diagnosed at FIGO stage I in 78.9% of cases, are usually young, and have a favorable prognosis with 5-year survival affecting more than 80% of patients.
Surgical treatment of perimenopausal and postmenopausal BOT requires bilateral annissiectomy. Otherwise, the role of hysterectomy in perimenopausal and postmenopausal women with early-stage BOT remains unclear. Although some studies have reported an increased recurrence rate in the group of patients treated with uterine preservation, these data are severely limited by the small sample of patients and the presence of confounding factors in the analysis of oncologic outcomes.
Determining the impact of hysterectomy on the survival outcomes of perimenopausal and postmenopausal patients diagnosed with early FIGO stage BOT is necessary to avoid overtreatment, hysterectomy being associated with a low but not negligible rate of morbidity and mortality.
- Conditions
- Hysterectomy
- Keywords
- Borderline ovarian tumours, gynaecology, perimenopause, postmenopause
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of uterine preservation on the rate of BOT recurrence
Impact of uterine preservation on the rate of borderline ovarian tumors (BOT) recurrence and thus its usefulness or otherwise in clinical care practice; therefore, the overall recurrence rate (which includes BOT, invasive BOT implants, and carcinoma) in patients treated with (group 1) and without (group 2) hysterectomy will be determined
Measured: After surgery during follow up (up to 20 years)
Secondary outcomes (6)
The rate of recurrence of BOT and of invasive implants
Improved care practice by determining in patients with BOT undergoing (group 1) or not undergoing (group 2) hysterectomy the rate of recurrence of BOT and of invasive implants
Measured: After surgery during follow up (up to 20 years)
The rate of carcinoma recurrence
Improved care practice by determining in patients with BOT undergoing (group 1) or not undergoing (group 2) hysterectomy the rate of carcinoma recurrence
Measured: After surgery during follow up (up to 20 years)
the overall survival (OS) defined as the time from surgery to the patient's death from any cause
Improved care practice by determining in patients with BOT undergoing (group 1) or not undergoing (group 2) hysterectomy the overall survival (OS) defined as the time from surgery to the patient's death from any cause
Measured: After surgery during follow up (up to 20 years)
disease-free survival (DFS) defined as time from surgery to recurrence
Improved care practice by determining in patients with BOT undergoing (group 1) or not undergoing (group 2) hysterectomy disease-free survival (DFS) defined as time from surgery to recurrence
Measured: After surgery during follow up
disease-specific survival (DSS) defined as the time from first surgery for BOT to death from disease
Improved care practice by determining in patients with BOT undergoing (group 1) or not undergoing (group 2) hysterectomy disease-specific survival (DSS) defined as the time from first surgery for BOT to death from disease
Measured: After surgery during follow up (up to 20 years)
the rate of postoperative complications
Improved care practice by determining in patients with BOT undergoing (group 1) or not undergoing (group 2) hysterectomy the rate of postoperative complications
Measured: After surgery during follow up (up to 20 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start10 Jan 2022
- Primary completion31 Dec 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diego Raimondo, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825468
- Sponsor's protocol ID
- HYSTEROBOT
- Status last verified
- Nov 2024
- First submitted
- 30 Dec 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role Of Hysterectomy In The Treatment Of Borderline Ovarian Tumors
- ClinicalTrials.gov ID
- NCT06825468
- Acronym / sponsor ID
- HYSTEROBOT
- Conditions
- Hysterectomy
- Keywords
- Borderline ovarian tumours, gynaecology, perimenopause, postmenopause
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 13 Feb 2025 (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 (BOT), are rare epithelial ovarian tumors characterized by the presence of frankly malignant cytologic features in the absence of stromal invasion.
Surgical treatment of perimenopausal and postmenopausal BOT requires bilateral adnexectomy. Although some studies have reported an increased recurrence rate in the group of patients treated with uterine preservation, these data are severely limited by the small sample of patients and the presence of confounding factors in the analysis of oncologic outcomes.
Determining the impact of hysterectomy on the survival outcomes of perimenopausal and postmenopausal patients diagnosed with early FIGO stage BOT is necessary to avoid overtreatment, hysterectomy being associated with a low but not negligible rate of morbidity and mortality.
Detailed description
Borderline ovarian tumors (BOTs), are rare epithelial ovarian tumors characterized by the presence of frankly malignant cytologic features in the absence of stromal invasion. Serous BOTs, which account for 67% of all BOTs, are limited to one ovary in 75% of cases and are frequently accompanied by predominantly noninvasive peritoneal implants. In 30% of cases, BOTs are mucinous, unilateral, and characterized by a low rate of extra-ovarian spread and invasive implants. Patients with BOT are diagnosed at FIGO stage I in 78.9% of cases, are usually young, and have a favorable prognosis with 5-year survival affecting more than 80% of patients.
Surgical treatment of perimenopausal and postmenopausal BOT requires bilateral annissiectomy. Otherwise, the role of hysterectomy in perimenopausal and postmenopausal women with early-stage BOT remains unclear. Although some studies have reported an increased recurrence rate in the group of patients treated with uterine preservation, these data are severely limited by the small sample of patients and the presence of confounding factors in the analysis of oncologic outcomes.
Determining the impact of hysterectomy on the survival outcomes of perimenopausal and postmenopausal patients diagnosed with early FIGO stage BOT is necessary to avoid overtreatment, hysterectomy being associated with a low but not negligible rate of morbidity and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with BOT diagnosis will be included in the study for analysis: * BSO and hysterectomy (group 1) * BSO without hysterectomy (group 2)
Key inclusion criteria (4 listed)
- Women in menopause clinically defined as absence of menstrual cycle for 12 months
- Primary diagnosis of BOT confirmed by pathological examination
- Surgical treatment of BOT by BSO with (group 1) and without (group 2) hysterectomy
- Informed consent acquisition
Key exclusion criteria (6 listed)
- Occurrence of BOT at index intervention
- Stage IV
- Metastatic disease
- Patients with previous hysterectomy
- Cancer synchronous of the endometrium
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
Impact of uterine preservation on the rate of BOT recurrence
Time frame: After surgery during follow up (up to 20 years)
Impact of uterine preservation on the rate of borderline ovarian tumors (BOT) recurrence and thus its usefulness or otherwise in clinical care practice; therefore, the overall recurrence rate (which includes BOT, invasive BOT implants, and carcinoma) in patients treated with (group 1) and without (group 2) hysterectomy will be determined
6 secondary outcomes
The rate of recurrence of BOT and of invasive implants
Time frame: After surgery during follow up (up to 20 years)
The rate of carcinoma recurrence
Time frame: After surgery during follow up (up to 20 years)
the overall survival (OS) defined as the time from surgery to the patient's death from any cause
Time frame: After surgery during follow up (up to 20 years)
disease-free survival (DFS) defined as time from surgery to recurrence
Time frame: After surgery during follow up
disease-specific survival (DSS) defined as the time from first surgery for BOT to death from disease
Time frame: After surgery during follow up (up to 20 years)
the rate of postoperative complications
Time frame: After surgery during follow up (up to 20 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
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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.
Diego Raimondo, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hysterectomy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 3 sites in Italy.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Impact of uterine preservation on the rate of BOT recurrence (time frame: After surgery during follow up (up to 20 years)). 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 13 Feb 2025.