Clinical trial · Interventional
Biopsy Needle Size in Soft Tissue Sarcoma
Diagnostic Accuracy of Different Tru-Cut Needle Sizes in Soft Tissue Sarcomas: A Prospective Blinded Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. 1. Is there any difference between the diagnostic accuracy measurements of 14G, 16G and 18G tru-cut biopsy needles for diagnosis of soft tissue sarcomas in extremities? 2. Do tumor size, tumor depth, tumor subtype and histological grade of the tumor affect the "matching score"s of biopsies? 3. Do tumor size, tumor depth, tumor subtype and histological grade of the tumor affect the biopsy result concordance and/or diagnostic accuracy measurements? 4. Does needle gauge effect successful tumoral tissue sampling or prediction of histological grade of soft tissue sarcomas?
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma of the Limb | Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tru-cut Biopsy with 14 G Needle | Diagnostic Test | — | UNRESOLVED |
| Tru-cut Biopsy with 16G tru-cut needle | Diagnostic Test | — | UNRESOLVED |
| Tru-cut Biopsy with 18G tru-cut needle | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 14G Needle
- description
- Each patient undergoes a tru-cut biopsy with a 14 G needle, obtaining 5 tissue cores (tumor center, superior, inferior, medial, lateral).
- interventionNames
- Diagnostic Test: Tru-cut Biopsy with 14 G Needle
- type
- EXPERIMENTAL
- label
- 16G Needle
- description
- 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
- interventionNames
- Diagnostic Test: Tru-cut Biopsy with 16G tru-cut needle
- type
- EXPERIMENTAL
- label
- 18G Needle
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients presenting to the Orthopedic Oncology outpatient clinic at Ankara Bilkent City Hospital with suspected or preliminary findings on physical examination suggesting soft tissue sarcoma. 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: * Patients with a prior diagnosis of the existing mass, coagulation disorders, active infection at the tumor site, a history of previous surgery or radiotherapy to the tumor region, medical conditions contraindicating tru-cut biopsy, or those who did not consent to participate after detailed explanation of the study, were excluded.
References
Publications (1)
- BACKGROUNDBirgin E, Yang C, Hetjens S, Reissfelder C, Hohenberger P, Rahbari NN. Core needle biopsy versus incisional biopsy for differentiation of soft-tissue sarcomas: A systematic review and meta-analysis. Cancer. 2020 Jan 1;126(9):1917-1928. doi: 10.1002/cncr.32735. Epub 2020 Feb 5. PMID 32022262