Ovarian Malignancy Incidence in Moderate Risk Women With... | NCT02247323

Studies
Ovarian Malignancy Incidence in Moderate Risk Women With Low CA 125

NCT02247323

Sponsor

Beni-Suef University

Status

Unknown status

Last Update Posted

Feb 2, 2021Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Ovarian Cancer

Interventions

Risk of malignancy index

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

Jan 2021

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

Jan 2016

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Sep 19, 2014

First Submission Date that Met QC Criteria

Sep 23, 2014

First Posted Date

Sep 25, 2014Estimated

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

Jan 30, 2021

Last Update Posted Date

Feb 2, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nesreen Abdel Fattah Abdullah Shehata, Assistant Professor of Obstetrics and Gynecology, Beni-Suef UniversityPrincipal Investigator

Lead Sponsor

Beni-Suef UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 investigators are assessing the incidence of ovarian cancer in premenopausal women who were at moderate risk of malignancy with low CA125.

Detailed Description

About 10% of premenopausal women may have a surgery for ovarian masses. In premenopausal women the incidence of ovarian malignancy is 1:1000 in case of symptomatic ovarian cyst.1 CA125 is unreliable in differentiating benign from malignant ovarian mass in premenopausal women due to many false positive results and reduced specificity.1 pelvic vaginal ultrasonography is the most effective tool in evaluating ovarian masses due to increased sensitivity over abdominal US.1 An estimation of risk of malignancy index is essential in evaluating an ovarian mass.26 /2 Risk of malignancy index combines presurgical features serum including CA125, menopausal status and ultrasound findings. RMI=Ux Mx CA125 in which each feature takes a score and after calculation score less than 25 is mild, from 25-250 moderate and more than 250 has a severe risk of malignancy needing oncologist.44/3

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
premenopausal women		premenopausal women with complex ovarian mass moderate for malignancy by risk of malignancy index score and low CA125.	Other: Risk of malignancy index

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Risk of malignancy index	Other	Calculation of RMI before sugery.	premenopausal women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of ovarian malignancy	Calculation of number of women who had ovarian cancer after an operation in moderate risk	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women with complex ovarian cyst
Abdominal pain
Menometrorrhagia

Exclusion Criteria:

Significant weight loss
Cachexia
History of ovarian or other malignancy
Family history of ovarian Cancer

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Premenopausal who had complex ovarian mass with low CA125 and at moderate risk for malignancy by RMI.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nesreen A Shehata, MD	Contact	00201227866337		nesoomar@yahoo.com
Abdelgany M Hassan, MD	Contact	00201017801604		abdelgany2@gmail.com

Overall Officials

Name	Affiliation	Role
Nesreen A Shehata, MD	Beni-Suef University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beni-Suef University	Recruiting	Cairo			Egypt

References Module

Citations

Not provided

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