NCT02940041

Brief Summary

Determine the concordance between gynaecological sonography and pelvic MRI for the pre-surgical diagnosis of uterine malignant tumors.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

Status
terminated

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

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

December 26, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

October 18, 2016

Last Update Submit

December 19, 2023

Conditions

LeiomyomaLeiomyosarcoma

Keywords

DiagnosisSonographyMagnetic Resonance

Outcome Measures

Primary Outcomes (1)

  • Concordance Between Gynaecologic Sonography Amd Pelvic MRI

    We expect to recruit 50 patients in 1 year period

Secondary Outcomes (1)

  • Determine sensibility for sonographic and MRI specific parameters on diagnosis uterine malignant tumors

    We expect to recruit 50 patients in 1 year period

Interventions

Pre-surgical diagnosis of uterine malignant tumorsPROCEDURE

All patientes who fit inclusion criteria will undergo a gynecologic sonography, pelvic MRI, determination of LDH, as in regular practice. No additional interventions will be done to any patient.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women over 18 years old with uterine leiomyomas who have \>2 risk factors for mesenquimal uterine malignant tumor OR sonographic suspicion of atypical leiomyoma.

You may qualify if:

  • \>18 years old
  • Accept to participate in the study
  • uterine leiomyomas who have \>2 risk factors for mesenchymal uterine malignant tumor OR sonographic suspicion of atypical leiomyoma.

You may not qualify if:

  • \< 18 years
  • Not being capable of understanding the study design

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

LeiomyomaLeiomyosarcomaDisease

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcomaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

October 18, 2016

First Posted

October 20, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2021

Last Updated

December 26, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share