NCT05791838

Brief 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. From January 2010 to December 2017, all patients with BOTs undergoing surgical treatment were included. Demographic, clinical, and pathological data were reviewed retrospectively.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

Same day

First QC Date

February 8, 2023

Last Update Submit

March 17, 2023

Conditions

Borderline Ovarian Tumor

Keywords

Conservative surgeryMicropapillary patternsSurgical staging

Outcome Measures

Primary Outcomes (1)

  • Oncological outcome

    Patients who underwent surgery for BOT

    through study completion, an average of 1 year

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients surgically treated for borderline ovarian tumors (BOT)

You may qualify if:

  • 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.

You may not qualify if:

  • \- Women affected by ovarian cancers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Basilio Pecorino, M.D.

    University of Catania

    PRINCIPAL INVESTIGATOR

  • Paolo Scollo, M.D. Ph.D.

    University of Catania

    STUDY DIRECTOR

  • Antonio Simone Laganà, M.D. Ph.D.

    University of Palermo

    STUDY CHAIR

  • Andrea Etrusco, M.D.

    University of Palermo

    STUDY CHAIR

Central Study Contacts

Andrea Etrusco, M.D.

CONTACT

+393881715032etruscoandrea@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 8, 2023

First Posted

March 30, 2023

Study Start

March 1, 2023

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

March 30, 2023

Record last verified: 2023-03