Clinical trial · Observational
MYometrial Lesion UltrasouNd And mRi
NCT04123158CI-TRIAL-00077207MYLUNARcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A monocentric prospective observational study aimed at assessing the accuracy of a diagnostic algorithm to pre-operatively identify uterine sarcomas.. Primary Aim:The primary outcome is to evaluate the accuracy (sensitivity/specificity) of "Positive Orange Criteria" category in predicting uterine sarcoma and STUMP in the population of patients with \> 3 cm myometrial lesions.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma Uterus | Myoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Diagnostic Test | — | UNRESOLVED |
| Ultrasound | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- WHITE
- description
- If no Green Card criteria is fulfilled (Negative Green Criteria), the patient will receive an annual telephone follow up for 2 years.
- interventionNames
- Diagnostic Test: Ultrasound
- label
- GREEN
- description
- Patients will be assessed by a Green Card to check the eventual presence of at least one of the following clinical and/or ultrasound characteristics. * If one or more Green Card criteria is present (Positive Green Criteria), a dedicated clinical and ultrasound paper form will be fulfilled in order to check the presence of the criteria described in the Orange Card * In case of "negative Orange Criteria" (no Orange Card criteria, or only one Orange Card criteria, or only Orange clinical criteria) the patient will be scheduled for longitudinal follow up at 6, 12 and 24 months. At each follow-up visit, a transvaginal ultrasound examination will be performed (using the MYLUNAR Paper Form) and the patient will be re-evaluated according to the Orange Card. In case of "positive Orange Criteria" the patient will be triaged to MRI and surgery. Eventual treatment for the myometrial lesion during the study period will be recorded and the outcome of these patients will be described separately.
- interventionNames
- Diagnostic Test: Ultrasound
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Consecutive patients admitted to our Department for transvaginal ultrasound examination, in whom a myometrial lesion \> 3cm in size is detected. * Informed consent form signed by the patient. Exclusion Criteria: * Patients undergoing medical treatment for myometrial lesion; * Patients previously treated with hormonal therapy including estroprogestin in the last six months; * Patients previously treated by embolization
References
Publications (5)
- BACKGROUNDDenschlag D, Thiel FC, Ackermann S, Harter P, Juhasz-Boess I, Mallmann P, Strauss HG, Ulrich U, Horn LC, Schmidt D, Vordermark D, Vogl T, Reichardt P, Gass P, Gebhardt M, Beckmann MW. Sarcoma of the Uterus. Guideline of the DGGG (S2k-Level, AWMF Registry No. 015/074, August 2015). Geburtshilfe Frauenheilkd. 2015 Oct;75(10):1028-1042. doi: 10.1055/s-0035-1558120. PMID 26640293
- BACKGROUNDPritts EA, Vanness DJ, Berek JS, Parker W, Feinberg R, Feinberg J, Olive DL. The prevalence of occult leiomyosarcoma at surgery for presumed uterine fibroids: a meta-analysis. Gynecol Surg. 2015;12(3):165-177. doi: 10.1007/s10397-015-0894-4. Epub 2015 May 19. PMID 26283890
- BACKGROUNDMahnert N, Morgan D, Campbell D, Johnston C, As-Sanie S. Unexpected gynecologic malignancy diagnosed after hysterectomy performed for benign indications. Obstet Gynecol. 2015 Feb;125(2):397-405. doi: 10.1097/AOG.0000000000000642. PMID 25569001
- BACKGROUNDNorris HJ, Taylor HB. Mesenchymal tumors of the uterus. I. A clinical and pathological study of 53 endometrial stromal tumors. Cancer. 1966 Jun;19(6):755-66. doi: 10.1002/1097-0142(196606)19:63.0.co;2-u. No abstract available. PMID 5939046
- RESULTKoh WJ, Greer BE, Abu-Rustum NR, Apte SM, Campos SM, Cho KR, Chu C, Cohn D, Crispens MA, Dizon DS, Dorigo O, Eifel PJ, Fisher CM, Frederick P, Gaffney DK, George S, Han E, Higgins S, Huh WK, Lurain JR 3rd, Mariani A, Mutch D, Fader AN, Remmenga SW, Reynolds RK, Tillmanns T, Valea FA, Yashar CM, McMillian NR, Scavone JL; National Comprehensive Cancer Network. Uterine Sarcoma, Version 1.2016: Featured Updates to the NCCN Guidelines. J Natl Compr Canc Netw. 2015 Nov;13(11):1321-31. doi: 10.6004/jnccn.2015.0162. PMID 26553763