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Diagnostic Value of Transcervical True-Cut Biopsy in Uterine Masses

Diagnostic Value of Transcervical True-Cut Biopsy in Uterine Masses

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07264660
Enrollment
42
Registered
2025-12-04
Start date
2025-12-01
Completion date
2027-01-01
Last updated
2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Tumor

Brief 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

Interventions

PROCEDURETranscervical True-Cut Biopsy

Transcervical True-Cut Biopsy in Uterine Masses

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

* • Women diagnosed with uterine tumor-like masses by imaging and scheduled for surgical excision. * Non-virgin patients .

Exclusion criteria

* • Patients with active genital tract infection. * Patients with bleeding disorders or on uncorrected anticoagulation therapy. * .Pregnancy.

Design outcomes

Primary

MeasureTime frameDescription
• Diagnostic accuracy of transcervical ultrasound-guided true-cut biopsy compared to the gold standard excisional biopsy1 year• Diagnostic accuracy of transcervical ultrasound-guided true-cut biopsy compared to the gold standard excisional biopsy

Contacts

Primary ContactFatma Mohamed mokhtar, dr
fatmaelzahraamohamed59@gmail.com01094632860
Backup ContactHany mohammed saif, prof
Hany.saif@med.au20 10 05618665

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026