Experience in Borderline Ovarian Tumors | NCT05791838

Studies
Experience in Borderline Ovarian Tumors

NCT05791838

Sponsor

University of Palermo

Status

Unknown status

Last Update Posted

Mar 30, 2023Actual

Enrollment

86Estimated

Phase

Not provided

Conditions

Borderline Ovarian Tumor

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2023Estimated

Primary Completion Date

Mar 2023Estimated

Completion Date

Mar 2023Estimated

First Submitted Date

Feb 8, 2023

First Submission Date that Met QC Criteria

Mar 17, 2023

First Posted Date

Mar 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2023

Last Update Posted Date

Mar 30, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

86Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oncological outcome	Patients who underwent surgery for BOT	through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

- Women affected by ovarian cancers

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients surgically treated for borderline ovarian tumors (BOT)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrea Etrusco, M.D.	Contact	+393881715032		etruscoandrea@gmail.com

Overall Officials

Name	Affiliation	Role
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.

Locations

Not provided