Concordance Between Sonography Amd MRI for Presurgical Diagnosis of Uterine Mesenchymal Malignant Tumors (CERTUM)

December 19, 2023 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Concordance Between Gynaecologic Sonography Amd Pelvic MRI for the Pre-surgical Diagnosis of Uterine Mesenchymal Malignant Tumors

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The hypothesis that will be evaluated with this study is the concordance between the sonographic assessment following the terms and definitions to describe uterine pathology proposed by Morphological Uterus Sonographic Assessment (MUSA) and the pelvic MRI for the pre-surgical diagnosis of malignant mesenchymal uterine tumors in patients affected of symptomatic leiomyomas with clinical or sonographic risk factors for atypical fibroids.

If both explorations have the same efficiency for the diagnosis, one of those should be avoided, diminishing the costs and surgery delay for these patients.

Those women with uterine leiomyoma who present >2 risk factors for uterine malignant mesenchymal tumors OR with sonographic criteria for atypical leiomyoma will be invited to participate in the study and will sign the informed consent.

After this first visit, the patient will undergo a gynecological sonography, serum lactate dehydrogenase (LDH) determination and a pelvic MRI, as it is done in our regular clinical practice.

All explorations will be performed in the same study center and will be done by independent physicians.

Then patients included will be addressed to a second visit to explain the results and surgery planning if it's needed.

One month after the surgery, one last visit will be conducted to perform a post-surgery control and give the final anatomo-pathological report of the surgery specimen. All data will be entered in the database for further analysis.

Study Type

Observational

Enrollment (Actual)

15

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • >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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concordance Between Gynaecologic Sonography Amd Pelvic MRI
Time Frame: We expect to recruit 50 patients in 1 year period
We expect to recruit 50 patients in 1 year period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine sensibility for sonographic and MRI specific parameters on diagnosis uterine malignant tumors
Time Frame: We expect to recruit 50 patients in 1 year period
Sonographic parameters : Undefined margins, Unique or multiple lesions, Size and Color-score (1,2,3,4) MRI parameters: Heterogenic or intermediate T2 Signal intensity , High or Intermediate b1000 signal, Apparent diffusion parameter <1.23, heterogeneous contrast catchment
We expect to recruit 50 patients in 1 year period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

October 18, 2016

First Posted (Estimated)

October 20, 2016

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-TUM-2016-30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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