Uterine TumorNCT07264660
Diagnostic Value of Transcervical True-Cut Biopsy in Uterine Masses
An observational study of Uterine Tumor, run by Assiut University.
Trial 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]. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Tumor
- What is being tested?
- Transcervical True-Cut Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: • Women diagnosed with uterine tumor-like masses by imaging and scheduled for surgical excision
Who may be able to join
- • Women diagnosed with uterine tumor-like masses by imaging and scheduled for surgical excision.
- Non-virgin patients .
Who cannot join
- • Patients with active genital tract infection.
- Patients with bleeding disorders or on uncorrected anticoagulation therapy.
- .Pregnancy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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
- Being tested
- Transcervical True-Cut Biopsy
- Medical subject headings
- Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcervical True-Cut BiopsyProcedure or surgery
Transcervical True-Cut Biopsy in Uterine Masses
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Procedure: Transcervical True-Cut Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Diagnostic accuracy of transcervical ultrasound-guided true-cut biopsy compared to the gold standard excisional biopsy
- Diagnostic accuracy of transcervical ultrasound-guided true-cut biopsy compared to the gold standard excisional biopsy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Uterine TumorStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma AL_Zahraa Mohamed Mokhtar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264660
- Sponsor's protocol ID
- Biopsy in Uterine Masses
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Park JJ, Kim CK, Park BK. Ultrasound-Guided Transvaginal Core Biopsy of Pelvic Masses: Feasibility, Safety, and Short-Term Follow-Up. AJR Am J Roentgenol. 2016 Apr;206(4):877-82. doi: 10.2214/AJR.15.15702. Epub 2016 Feb 25.
PubMed 26913556Asp M, Mockute I, Masback A, Liuba K, Kannisto P, Malander S. Tru-Cut Biopsy in Gynecological Cancer: Adequacy, Accuracy, Safety and Clinical Applicability. J Multidiscip Healthc. 2023 May 15;16:1367-1377. doi: 10.2147/JMDH.S396788. eCollection 2023.
PubMed 37215751Quintana-Berto R, Padilla-Iserte P, Gil-Moreno A, Oliver-Perez R, Coronado PJ, Martin-Salamanca MB, Pantoja-Garrido M, Lorenzo C, Beric D, Gilabert-Estelles J, Sanchez L, Roldan-Rivas F, Diaz-Feijoo B, Rodriguez-Hernandez JR, Marcos-Sanmartin J, Muruzabal JC, Canada A, Domingo S; SEGO Spain-GOG Group. Preoperative sampling in endometrial cancer: evaluation of the histopathological agreement with definitive surgical specimen. Clin Transl Oncol. 2022 Dec;24(12):2388-2394. doi: 10.1007/s12094-022-02893-w. Epub 2022 Aug 19.
PubMed 35984612Asaturova A, Zaretsky A, Rogozhina A, Tregubova A, Badlaeva A. Advancements in Minimally Invasive Techniques and Biomarkers for the Early Detection of Endometrial Cancer: A Comprehensive Review of Novel Diagnostic Approaches and Clinical Implications. J Clin Med. 2024 Dec 11;13(24):7538. doi: 10.3390/jcm13247538.
PubMed 39768459
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Transcervical True-Cut Biopsy in Uterine Masses
- ClinicalTrials.gov ID
- NCT07264660
- Acronym / sponsor ID
- Biopsy in Uterine Masses
- Conditions
- Uterine Tumor
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Transcervical True-Cut Biopsy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- • Women diagnosed with uterine tumor-like masses by imaging and scheduled for surgical excision
Key inclusion criteria (2 listed)
- • Women diagnosed with uterine tumor-like masses by imaging and scheduled for surgical excision.
Key exclusion criteria (3 listed)
- • Patients with active genital tract infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcervical True-Cut BiopsyTranscervical True-Cut Biopsy in Uterine Masses | Procedure or surgery | 1 |
Primary outcome
• Diagnostic accuracy of transcervical ultrasound-guided true-cut biopsy compared to the gold standard excisional biopsy
Time frame: 1 year
• Diagnostic accuracy of transcervical ultrasound-guided true-cut biopsy compared to the gold standard excisional biopsy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Background: PubMed 26913556Park JJ, Kim CK, Park BK. Ultrasound-Guided Transvaginal Core Biopsy of Pelvic Masses: Feasibility, Safety, and Short-Term Follow-Up. AJR Am J Roentgenol. 2016 Apr;206(4):877-82. doi: 10.2214/AJR.15.15702. Epub 2016 Feb 25.
- Background: PubMed 37215751Asp M, Mockute I, Masback A, Liuba K, Kannisto P, Malander S. Tru-Cut Biopsy in Gynecological Cancer: Adequacy, Accuracy, Safety and Clinical Applicability. J Multidiscip Healthc. 2023 May 15;16:1367-1377. doi: 10.2147/JMDH.S396788. eCollection 2023.
- Background: PubMed 35984612Quintana-Berto R, Padilla-Iserte P, Gil-Moreno A, Oliver-Perez R, Coronado PJ, Martin-Salamanca MB, Pantoja-Garrido M, Lorenzo C, Beric D, Gilabert-Estelles J, Sanchez L, Roldan-Rivas F, Diaz-Feijoo B, Rodriguez-Hernandez JR, Marcos-Sanmartin J, Muruzabal JC, Canada A, Domingo S; SEGO Spain-GOG Group. Preoperative sampling in endometrial cancer: evaluation of the histopathological agreement with definitive surgical specimen. Clin Transl Oncol. 2022 Dec;24(12):2388-2394. doi: 10.1007/s12094-022-02893-w. Epub 2022 Aug 19.
- Background: PubMed 39768459Asaturova A, Zaretsky A, Rogozhina A, Tregubova A, Badlaeva A. Advancements in Minimally Invasive Techniques and Biomarkers for the Early Detection of Endometrial Cancer: A Comprehensive Review of Novel Diagnostic Approaches and Clinical Implications. J Clin Med. 2024 Dec 11;13(24):7538. doi: 10.3390/jcm13247538.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Tumor, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma Mohamed mokhtar, dr (01094632860, fatmaelzahraamohamed59@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Diagnostic accuracy of transcervical ultrasound-guided true-cut biopsy compared to the gold standard excisional biopsy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07264660, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.