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Concordance Between Gynaecologic Sonography Amd Pelvic MRI for the Pre-surgical Diagnosis of Uterine Mesenchimal Malignant Tumors (CERTUM)

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ClinicalTrials.gov Identifier: NCT02940041
Recruitment Status : Unknown
Verified October 2016 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was:  Not yet recruiting
First Posted : October 20, 2016
Last Update Posted : October 20, 2016
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

Condition or disease Intervention/treatment
Leiomyoma Leiomyosarcoma Procedure: Pre-surgical diagnosis of uterine malignant tumors

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 MUSA (Morphological Uterus Sonographic Assessment) and the pelvic MRI for the pre-surgical diagnosis of malignant mesenquimal 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 mesenchimal 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 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 phisicians.

Then patients included will be adressed 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-patological report of the surgery specimen. All data will be entered in the database for futher analysis.


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Study Type : Observational
Estimated Enrollment : 50 participants
Time Perspective: Prospective
Official Title: Concordance Between Gynaecologic Sonography Amd Pelvic MRI for the Pre-surgical Diagnosis of Uterine Mesenchimal Malignant Tumors
Study Start Date : October 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


Intervention Details:
  • Procedure: Pre-surgical diagnosis of uterine malignant tumors
    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.


Primary Outcome Measures :
  1. Concordance Between Gynaecologic Sonography Amd Pelvic MRI [ Time Frame: We expect to recruit 50 patients in 1 year period ]

Secondary Outcome Measures :
  1. 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, heterogeneus contrast catchment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02940041     History of Changes
Other Study ID Numbers: IIBSP-TUM-2016-30
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: October 20, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Diagnosis
Sonography
Magnetic Ressonance
Additional relevant MeSH terms:
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Leiomyosarcoma
Leiomyoma
Neoplasms
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Sarcoma