NCT04123158Completed
MYometrial Lesion UltrasouNd And mRi
Source: ClinicalTrials.gov · Last updated 16 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 2353 (actual)
- First submitted
- 9 Oct 2019
- Start date
- 17 Jan 2019
- Primary completion date
- 4 Dec 2023
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT04123158
What you commit to
- Study type: Observational
- Participants enrolled: 2353
- From 17 Jan 2019 to the primary completion date, 4 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients previously treated with hormonal therapy including estroprogestin in the last six months;
- Patients previously treated by embolization
Other
- Patients undergoing medical treatment for myometrial lesion;
Who the study is looking for
- 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.
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Agostino Gemelli Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.