NCT04990076

Brief Summary

The main objective is to evaluate the diagnostic accuracy of the MUSA terms and definitions, as defined in the paper by Van den Bosch T, Dueholm M, ea. in 2015, to differentiate between different types of myometrial lesions of more than 1 cm. The primary aim is the diagnostic accuracy of the MUSA terms and definitions and the secondary aim the development of a prediction model.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 11, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

6.1 years

First QC Date

July 26, 2021

Last Update Submit

July 1, 2024

Conditions

Myoma;UterusSarcoma Uterus

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of the MUSA terms and definitions

    Around 50 ultrasound characteristics will be assess as to diagnostic accuracy as predictors (Prospective evaluation of MUSA terms and definitions).

    4 years

Secondary Outcomes (1)

  • Development of prediction model

    5 years

Study Arms (1)

Patients planned for hysterectomy with a myometrial lesion of more than 1 cm.

Procedure: Hysterectomy

Interventions

HysterectomyPROCEDURE

Surgery includes different types of hysterectomy: vaginal hysterectomy, total abdominal hysterectomy and laparoscopic or Robotic hysterectomy. The type of hysterectomy does not influence histological outcome, as long as the uterus is removed in one part (no power morcellation). Indications for surgery and the type of surgery are according to the departments' protocols. If the patient is deemed to be inoperable due to the extent of the disease, a representive biopsy (e.g. trucut biopsy) will be accepted if sufficiently motivated by the oncology team.

Patients planned for hysterectomy with a myometrial lesion of more than 1 cm.

Eligibility Criteria

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

Patients planned for hysterectomy with a myometrial lesion

You may qualify if:

  • Consecutive patients planned to undergo hysterectomy for myometrial pathology of more then 1cm (e.g. fibroid, focal adenomyosis, uterine sarcoma).

You may not qualify if:

  • Patient's refusal
  • Age \< 18 years
  • Polymyomatous uterus
  • Myometrial lesion with a diameter less then 10mm
  • Patients currently treated for another cancer
  • Patients with ovarian pathology, endometrial pathology of cervical pathology
  • Power morcellation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 300, Belgium

RECRUITING

Related Publications (2)

  • Van den Bosch T, Dueholm M, Leone FP, Valentin L, Rasmussen CK, Votino A, Van Schoubroeck D, Landolfo C, Installe AJ, Guerriero S, Exacoustos C, Gordts S, Benacerraf B, D'Hooghe T, De Moor B, Brolmann H, Goldstein S, Epstein E, Bourne T, Timmerman D. Terms, definitions and measurements to describe sonographic features of myometrium and uterine masses: a consensus opinion from the Morphological Uterus Sonographic Assessment (MUSA) group. Ultrasound Obstet Gynecol. 2015 Sep;46(3):284-98. doi: 10.1002/uog.14806. Epub 2015 Aug 10.

    PMID: 25652685BACKGROUND

  • Ludovisi M, Moro F, Pasciuto T, Di Noi S, Giunchi S, Savelli L, Pascual MA, Sladkevicius P, Alcazar JL, Franchi D, Mancari R, Moruzzi MC, Jurkovic D, Chiappa V, Guerriero S, Exacoustos C, Epstein E, Fruhauf F, Fischerova D, Fruscio R, Ciccarone F, Zannoni GF, Scambia G, Valentin L, Testa AC. Imaging in gynecological disease (15): clinical and ultrasound characteristics of uterine sarcoma. Ultrasound Obstet Gynecol. 2019 Nov;54(5):676-687. doi: 10.1002/uog.20270. Epub 2019 Oct 7.

    PMID: 30908820BACKGROUND

MeSH Terms

Conditions

Myofibroma

Interventions

Hysterectomy

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Dirk Timmerman, MD, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine De Bruyn, MD

CONTACT

+32 16 345125christine.debruyn@uzleuven.be

Study Design

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

Study Record Dates

First Submitted

July 26, 2021

First Posted

August 4, 2021

Study Start

March 11, 2020

Primary Completion

March 30, 2026

Study Completion

March 30, 2026

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)