Biopsy Needle Size in Soft Tissue Sarcoma

NCT07066774 | Completed

• 1 other identifier: E2-25-10025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.Do tumor size, tumor depth, tumor subtype and histological grade of the tumor affect the "matching score"s of biopsies?
3. 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. 4.Does needle gauge effect successful tumoral tissue sampling or prediction of histological grade of soft tissue sarcomas?

Conditions

Soft Tissue Sarcoma of the Limb

Keywords

needle size, soft tissue sarcoma, diagnostic accuracy

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to the end of study at 4 months

Study Arms (3)

14G Needle

EXPERIMENTAL

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

16G Needle

EXPERIMENTAL

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

18G Needle

EXPERIMENTAL

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

Interventions

Tru-cut Biopsy with 14 G Needle DIAGNOSTIC_TEST

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

14G Needle

Tru-cut Biopsy with 16G tru-cut needle DIAGNOSTIC_TEST

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

16G Needle

Tru-cut Biopsy with 18G tru-cut needle DIAGNOSTIC_TEST

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

18G Needle

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead
• Geotek Medical Products Industry and Trade Co., Ltd., Ankara, Türkiye: collaborator

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Cankaya, 06800, Turkey (Türkiye)

Location

Related Publications (1)

• Birgin 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 BACKGROUND

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 15, 2025
• Study Start: February 3, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 18, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)