Doppler Ultrasound and CT Versus Laparoscopy in Assessmen... | NCT06109545

Studies
Doppler Ultrasound and CT Versus Laparoscopy in Assessment of Ovarian Malignancy

NCT06109545

Sponsor

Mansoura University

Status

Unknown status

Last Update Posted

Oct 31, 2023Actual

Enrollment

95Estimated

Phase

Not provided

Conditions

Ovarian Cancer

Interventions

Laparoscopy

Countries

Egypt

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

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 24, 2023Actual

Primary Completion Date

Jun 1, 2025Estimated

Completion Date

Jun 1, 2025Estimated

First Submitted Date

Oct 25, 2023

First Submission Date that Met QC Criteria

Oct 25, 2023

First Posted Date

Oct 31, 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

Oct 25, 2023

Last Update Posted Date

Oct 31, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The aim of this study is to assess validation of ultrasound (± Doppler) parameters in the diagnosis of suspicious ovarian malignant tumors and laparoscopic assessment of these findings according to Fagotti score evaluation of suspicious malignant tumors

Detailed Description

The aim of this study is to asses validation of ultrasound (± Doppler) parameters in the diagnosis of suspicious ovarian malignant tumors and laparoscopic assessment of these findings according to Fagotti score evaluation of suspicious malignant tumors

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

95Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Women with suspicion of ovarian malignancy		Women with suspicion of ovarian malignancy depending on ultrasound, CT, MRI and CA 125	Procedure: Laparoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopy	Procedure	Patients included in this study will have diagnostic laparoscopy type WOLF done after checking all above ultrasound parameters of malignant tumor. This procedure will be done under general anathesia then a verses needle will be used at umbilicus or at palmer point if the mass is large or in cases of umbilical hernia or previous abdominal or pelvic surgery, then Fagotti criteria will be assessed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fagotti score	Laparoscopic staging of suspicious ovarian mass	Al time of laparoscopy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients with clinical or radiological suspicion of ovarian cancer.
at least one of clinical presentation of suspected or advanced ovarian cancer and performed ultrasound or CT or MRI that detect a pelvic mass and CA125 is more than 200 UL/ML.
patients with eastern Cooperative Oncology Group status from 0 to 3.

Exclusion Criteria:

the women outside the age group in our study.
any known malignancy at other sites.
uncompliant patients who have severed uncontrolled infection or any other medical problem.
any previous major surgery.
patients who refuse to give an informed consent to do laparoscopy.
pregnancy and its complications.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Women with suspicious ovarian malignancy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sarah Madany, MSc	Contact	+201027991297		sarahmadany20@gmail.com

Overall Officials

Name	Affiliation	Role
Sarah Madany, MSc	Mansoura University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura University Hospital	Recruiting	Al Mansurah	Dakahlia Governorate		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010535	Laparoscopy

Ancestor Terms

ID	Term
D004724	Endoscopy
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided