NCT02247323

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

September 19, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

5.9 years

First QC Date

September 19, 2014

Last Update Submit

January 30, 2021

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Incidence of ovarian malignancy

    Calculation of number of women who had ovarian cancer after an operation in moderate risk

    one year

Study Arms (1)

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

Risk of malignancy indexOTHER

Calculation of RMI before sugery.

Also known as: RMI
premenopausal women

Eligibility Criteria

Age45 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Women with complex ovarian cyst
  • Abdominal pain
  • Menometrorrhagia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-Suef University

Cairo, Egypt

RECRUITING

Related Links

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Nesreen A Shehata, MD

    Beni-Suef University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nesreen A Shehata, MD

CONTACT

00201227866337nesoomar@yahoo.com

Abdelgany M Hassan, MD

CONTACT

00201017801604abdelgany2@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

September 19, 2014

First Posted

September 25, 2014

Study Start

January 1, 2016

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

February 2, 2021

Record last verified: 2021-01

Locations

EG(1)