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Diagnostic Value of Transcervical True-Cut Biopsy in Uterine Masses

NCT07264660 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2025-12-04

No results posted yet for this study

Summary

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

Conditions

  • Uterine Tumor

Interventions

PROCEDURE

Transcervical True-Cut Biopsy

Transcervical True-Cut Biopsy in Uterine Masses

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-12-01
Completion
2027-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07264660 on ClinicalTrials.gov