NCT06403072

Brief Summary

prospective study was conducted and performed on 100 women with pelvic pain due to accidently discovered adnexal mass

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2023

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2024

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

1.6 years

First QC Date

May 3, 2024

Last Update Submit

May 3, 2024

Conditions

Ovarian Cancer

Keywords

Gynecologic Imaging-Reporting and Data SystemAdnexal MassesOvarian cancer

Outcome Measures

Primary Outcomes (1)

  • The Gynecologic Imaging-Reporting and Data System (GI-RADS)

    is a reporting system that was created for reporting the findings in adnexal masses based on transvaginal ultrasonography.

    1 month from admission to ultrasound investigation and operation and finally histopathology report

Interventions

The Gynecologic Imaging-Reporting and Data System (GI-RADS)DIAGNOSTIC_TEST

The Gynecologic Imaging-Reporting and Data System (GI-RADS) using ultrasound

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

women with pelvic pain due to accidently discovered adnexal mass

You may qualify if:

  • Females complaining of pelvic pain due to adnexal mass

You may not qualify if:

  • Presence of Sure signs of malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-suef university Hospital

Banī Suwayf, 62511, Egypt

Location

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

  • Sara S Sara Salem

    Beni-Suef University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Study Record Dates

First Submitted

May 3, 2024

First Posted

May 7, 2024

Study Start

June 1, 2021

Primary Completion

January 4, 2023

Study Completion

January 30, 2023

Last Updated

May 7, 2024

Record last verified: 2024-05

Locations

EG(1)