NCT06825468Completed
Role of Hysterectomy in the Treatment of Borderline Ovarian Tumors
Source: ClinicalTrials.gov · Last updated 13 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 168 (actual)
- First submitted
- 30 Dec 2024
- Start date
- 10 Jan 2022
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Diseases
- Ovarian cancer, Childhood cancers
- NCT number
- NCT06825468
What you commit to
- Study type: Observational
- Participants enrolled: 168
- From 10 Jan 2022 to the primary completion date, 31 Dec 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with previous hysterectomy
Other illness
- Metastatic disease
- Cancer synchronous of the endometrium
Other
- Occurrence of BOT at index intervention
- Stage IV
- 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)
Who the study is looking for
- 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
Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Fondazione Policlinico Universitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Ospedale universitario, Azienda Sanitaria Universitaria Friuli Centrale Coordinator of this site? Confirm its status | Udine | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.