NCT03598335

Brief Summary

The aim of this study is to determine whether Ultrasound Doppler imaging can identify malignant tumors at a very early stage.

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 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

Study Start

First participant enrolled

July 1, 2018

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

July 16, 2018

Last Update Submit

July 16, 2018

Conditions

Malignant Tumor of Women's Reproductive System

Outcome Measures

Primary Outcomes (1)

  • Early characterization of malignant tumors

    Comparison of Ultrasound Doppler findings at different speeds between women without tumors, with benign tumors and with malignant tumors of reproductive system

    One year

Study Arms (3)

Women with malignant tumor

Women with malignant tumor in reproductive system

Device: Ultrasound

Women with benign tumor

Women with benign tumor in reproductive system

Device: Ultrasound

Women with no observed tumor

Women with no observed tumor in reproductive system

Device: Ultrasound

Interventions

UltrasoundDEVICE

Ultrasound imaging of women arriving at clinic for routine care

Women with benign tumorWomen with malignant tumorWomen with no observed tumor

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women presenting at the Hillel Yaffe Medical Center gynecological ultrasound clinic.

You may qualify if:

  • Women presenting for routine abdominal/vaginal ultrasound

You may not qualify if:

  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hille Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Alon Shrim, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Genya Peisahov, BSc

CONTACT

972-54-8886349genyap@hymc.gov.il

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2018

First Posted

July 26, 2018

Study Start

July 1, 2018

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

July 26, 2018

Record last verified: 2018-07

Locations

IL(1)