An interventional study of Tru-cut Biopsy with 14 G Needle and Tru-cut Biopsy with 16G tru-cut needle in Soft Tissue Sarcoma of the Limb, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey (Türkiye). Per ClinicalTrials.gov, last updated 2025-07-15.
Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Diagnostic
Soft tissue sarcomas (STS) require accurate biopsy for diagnosis, grading, and management decisions. Although tru-cut biopsy is widely used, the optimal needle gauge remains uncertain. This study aimed to compare diagnostic accuracy and biopsy concordance rates of 14 G, 16 G, and 18 G tru-cut biopsy needles for extremity STS.
In 2018, the National Comprehensive Cancer Network (NCCN) endorsed core-needle (tru-cut) biopsy as the preferred diagnostic modality for STSs [14]. They recommend obtaining at least three tissue core blocks through a single stab incision on the skin, with a 14-gauge needle, directing the needle along different trajectories. In clinical practice, both 14 G and 16 G cores are commonly used Although multiple tru-cut needle gauges are used in practice, to our knowledge, an ideal and safe biopsy needle that does not sacrife diagnostic performance has not been defined. This is a randomized prospective disagnostic accuracy study. Therefore we prospectively compared numerous variables (tumor size, tumor depth, subtype, histological grade etc.) with biopsy result concordance and diagnostic accuracy of 14 G, 16 G, and 18 G tru-cut needles in samples obtained from the same tumor for each patient with suspected extremity STS, to determine whether an optimal needle gauge exists.
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Patients presenting to the Orthopedic Oncology outpatient clinic at Ankara Bilkent City Hospital with suspected or preliminary findings on radiological imaging suggesting soft tissue sarcoma.
Patients with soft tissue masses in extremities which require pathological examination
Exclusion Criteria:
Each patient undergoes a tru-cut biopsy with a 14 G needle, obtaining 5 tissue cores (tumor center, superior, inferior, medial, lateral).
Diagnostic Test: Tru-cut Biopsy with 14 G Needle
Each participant underwent Percutaneous Tru-cut Biopsy with 16G tru-cut needles in a single session procedure and within-subject repeated measuring data is obtained
Diagnostic Test: Tru-cut Biopsy with 16G tru-cut needle
Each participant underwent Percutaneous Tru-cut Biopsy with 16G tru-cut needles in a single session procedure and within-subject repeated measuring data is obtained
Diagnostic Test: Tru-cut Biopsy with 18G tru-cut needle
Each participant underwent Percutaneous Tru-cut Biopsy with 14G tru-cut needle in a single session procedure. There are no studies to our knowledge to compare samples from the same tumor
Each participant underwent Percutaneous Tru-cut Biopsy with 16 tru-cut needle in a single session procedure. There are no studies to our knowledge to compare samples from the same tumor
Each participant underwent Percutaneous Tru-cut Biopsy with 18G tru-cut needle in a single session procedure. There are no studies to our knowledge to compare samples from the same tumor
Diagnostic accuracy methods
Sensitivity, specificity, positive predictive value, negative predictive value, false positive rate and false negative rate was analyzed for 3 different needle sizes
Time frame: From enrollment to the end of study at 4 months
Plan to share: No — IPD will no affect the study results or analysis.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Ankara City Hospital Bilkent