Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT04250766
Eligibility Criteria:
Inclusion Criteria:
1. Woman \>= 35 years old
2. Diagnosis of suspicious uterine tumor involving surgical management by laparoscopic hysterectomy with possible morcellation. Fibroma must be considered suspect, if at least one of the following characteristics is fulfilled:
1. Rapid tumor growth defined as ≥30% of the maximum diameter in 1-year interval based on imaging findings, or,
2. Symptomatic tumors in postmenopausal women presenting vaginal bleeding or pelvic pain or palpable masses or symptoms caused by pressure of neighbor organs such as dysuria and gastrointestinal symptoms, or,
3. Tumors characterized by certain suspicious ultrasound criteria such as size \> 8 cm, presence and distribution of vascularization, presence of intratumoral lesions, ultrasound heterogeneity, necrosis, cystic components, presence of calcification.
4. Genetical predisposal to cancer syndromes such as Lynch syndrome, hereditary leiomyomatosis or "renal cell cancer".
3. MRI performed according to the technical and interpretation criteria stipulated in the study within 30 days before the biopsy.
4. Uterine fibroma accessible to transvaginal echo-guided biopsy exclusively.
5. No contraindication to performing laparotomy surgery.
6. Voluntary signed written informed consent.
7. Patient with a social security in compliance with the French law.
Exclusion Criteria:
1. General contraindication(s) to performing a transvaginal echo-guided biopsy.
2. Biopsy by peritoneal approach (surgical or percutaneous).
3. History of treated cancer in the two years preceding inclusion or in progressive continuation.
4. Unfavorable anesthetic assessment that does not allow general anesthesia for the planned surgery.
5. Coagulation disorders contraindicating biopsy.
6. Pregnancy project.
7. Pregnant or lactating woman.
8. Impossibility of submitting to the medical examination of the test for geographical, social or psychological reasons.
9. Patient deprived of liberty under legal protection measure or unable to express her consent.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
35 Years
Study:
NCT04250766
Study Brief:
Protocol Section:
NCT04250766