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Completed

NCT Number: NCT06825468

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.

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Key information

Conditions

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. The rate of recurrence of BOT and of invasive implants

    Time frame: After surgery during follow up (up to 20 years)

    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

  2. The rate of carcinoma recurrence

    Time frame: After surgery during follow up (up to 20 years)

    Improved care practice by determining in patients with BOT undergoing (group 1) or not undergoing (group 2) hysterectomy the rate of carcinoma recurrence

  3. 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)

    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

  4. disease-free survival (DFS) defined as time from surgery to recurrence

    Time frame: After surgery during follow up

    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

  5. 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)

    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

  6. the rate of postoperative complications

    Time frame: After surgery during follow up (up to 20 years)

    Improved care practice by determining in patients with BOT undergoing (group 1) or not undergoing (group 2) hysterectomy the rate of postoperative complications

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Feb 13, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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