NCT07264660

Diagnostic Value of Transcervical True-Cut Biopsy in Uterine Masses

Not yet recruiting Last updated 4 December 2025

What this trial tests

trial testing Transcervical True-Cut Biopsy in Uterine Tumor in 42 participants. Not yet recruiting.

Timeline

1 December 2025

Primary endpoint
1 December 2026

1 January 2027

Quick facts

Lead sponsor	Assiut University
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	42
Start date	1 December 2025
Primary completion	1 December 2026
Estimated completion	1 January 2027

Drugs / interventions tested

• Transcervical True-Cut Biopsy

Conditions studied

• Uterine Tumor — all drugs for Uterine Tumor →

Sponsor

Assiut University

Who can join

Eligibility, female only, with Uterine Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Uterine tumor-like masses represent a wide spectrum of gynecological conditions, ranging from benign lesions such as myomas and adenomyosis to malignant tumors like endometrial carcinoma and leiomyosarcoma, as well as other entities including gestational trophoblastic disease \[4\]. Accurate preoperative diagnosis is crucial, since management varies from conservative follow-up to radical surgery or systemic therapy.

Imaging modalities such as ultrasound and MRI are essential in the initial evaluation of uterine masses, providing information on size, location, and internal characteristics. However, imaging alone often lacks specificity, as benign and malignant lesions may share overlapping features \[4\]. Thus, histopathological confirmation remains the gold standard.

Among available diagnostic approaches, transcervical ultrasound-guided true-cut biopsy offers unique advantages. Unlike dilatation and curettage, which may yield insufficient or fragmented tissue, this technique retrieves core samples with preserved architecture \[1\]. Compared to hysteroscopic biopsy, which mainly targets endometrial lesions and frequently requires anesthesia, the transcervical route can access intramural and submucosal lesions in a simple outpatient setting \[2\]. While Novak biopsy is suitable for outpatient endometrial sampling, it cannot adequately reach deeper myometrial or submucosal masses \[4\]. Furthermore, unlike the transabdominal approach, which may be limited by bowel interposition or patient habitus, the transcervical technique ensures direct, real-time ultrasound-guided targeting with high feasibility and accuracy \[3\].

Preliminary studies have demonstrated high sensitivity and specificity for transcervical true-cut biopsy \[1-3,5\]. However, prior research was often limited by small sample sizes, focus on specific pathologies rather than the full spectrum of uterine tumor-like masses, and lack of direct comparison with excisional biopsy as a gold standard. Therefore, this study will assess its diagnostic value in scheduled patients with uterine tumor-like masses, by evaluating the agreement between transcervical biopsy results and excisional biopsy. Ultimately, the aim is to determine whether this minimally invasive, outpatient technique can help avoid unnecessary surgeries in benign cases and ensure that patients with malignant disease proceed promptly to the most appropriate surgical intervention

Publications & conference data

No peer-reviewed publications indexed yet for this trial.