Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT07264660
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Value of Transcervical True-Cut Biopsy in Uterine Masses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-11-24', 'studyFirstSubmitQcDate': '2025-11-24', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• Diagnostic accuracy of transcervical ultrasound-guided true-cut biopsy compared to the gold standard excisional biopsy', 'timeFrame': '1 year', 'description': '• Diagnostic accuracy of transcervical ultrasound-guided true-cut biopsy compared to the gold standard excisional biopsy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uterine Tumor']}, 'referencesModule': {'references': [{'pmid': '26913556', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '37215751', 'type': 'BACKGROUND', 'citation': 'Asp 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.'}, {'pmid': '35984612', 'type': 'BACKGROUND', 'citation': 'Quintana-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.'}, {'pmid': '39768459', 'type': 'BACKGROUND', 'citation': 'Asaturova 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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nImaging 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.\n\nAmong 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\\].\n\nPreliminary 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'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '• Women diagnosed with uterine tumor-like masses by imaging and scheduled for surgical excision', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Women diagnosed with uterine tumor-like masses by imaging and scheduled for surgical excision.\n\n * Non-virgin patients .\n\nExclusion Criteria:\n\n* • Patients with active genital tract infection.\n\n * Patients with bleeding disorders or on uncorrected anticoagulation therapy.\n * .Pregnancy.'}, 'identificationModule': {'nctId': 'NCT07264660', 'briefTitle': 'Diagnostic Value of Transcervical True-Cut Biopsy in Uterine Masses', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Diagnostic Value of Transcervical True-Cut Biopsy in Uterine Masses', 'orgStudyIdInfo': {'id': 'Biopsy in Uterine Masses'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'interventionNames': ['Procedure: Transcervical True-Cut Biopsy']}], 'interventions': [{'name': 'Transcervical True-Cut Biopsy', 'type': 'PROCEDURE', 'description': 'Transcervical True-Cut Biopsy in Uterine Masses', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Fatma Mohamed mokhtar, dr', 'role': 'CONTACT', 'email': 'fatmaelzahraamohamed59@gmail.com', 'phone': '01094632860'}, {'name': 'Hany mohammed saif, prof', 'role': 'CONTACT', 'email': 'Hany.saif@med.au', 'phone': '20 10 05618665'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Fatma AL_Zahraa Mohamed Mokhtar', 'investigatorAffiliation': 'Assiut University'}}}}