Diagnostic Efficiency of Touch Imprints Versus Smears

Diagnostic Self Evaluation Clinical Trial

Official title:

Diagnostic Efficiency of Needle Core Biopsy Touch Imprints Versus Fine Needle Aspiration Smears at the Time of Rapid on Site Interpretation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03224910
• Other study ID #: 2017-0076
• Status: Completed
• Start date: July 18, 2017
• Est. completion date: May 2, 2018

Study information

• Verified date: May 2018
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Cytopathologists work along with radiologist in the diagnosis of lesions. Rapid on site interpretation (ROSE) of fine needle aspiration (FNA) smears of radiologically suspicious lesions is a common clinical practice. In the last years, the investigators have seen trend towards needle core biopsies of radiologically suspicious lesions. The investigators want to analyze the challenges of rapid on site interpretation of touch imprints (TI) of needle core biopsies (NCB) versus fine needle aspiration smears.

Description:

This is a retrospective study in which the investigators will analyze the quality of the smears and the touch imprints, the cellularity, the cytomorphologic features of the specimens and the presence of adequate material for ancillary studies. The specimens will be searched through the University of Mississippi Medical Center's Pathology Laboratory information system (Copath), from January 2011 to December 2017. The retrospective cases (January 2011 up to now) will be retrieved using natural language search of fine needle aspiration and touch imprints. The slides of those cases will be reviewed and the cytomorphologic features will be described.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 2, 2018
• Est. primary completion date: May 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 1. Computerized tomography (CT)-Guided Fine needle aspiration (FNA) /Needle core biopsy (NCB) specimens from any site.2. Ultrasound (US) guided FNA/NCB.

Exclusion Criteria:

• 1. Specimens obtained through endoscopic fine needle aspirations.2. US-guided specimens from thyroid3. Exfoliative specimens like sputum or urine4. Gynecologic cytology specimens.5. Outside cytology consult cases6. Pathologist performed FNA's

Related Conditions & MeSH terms

• Diagnostic Self Evaluation

Intervention

Other:
• Cytologic techniques used for rapid on site interpretation
Diagnostic efficiency of touch imprints of needle core biopsies vs smears of fine needle aspirations during rapid on-site interpretation

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

Aisner DL, Sams SB. The role of cytology specimens in molecular testing of solid tumors: techniques, limitations, and opportunities. Diagn Cytopathol. 2012 Jun;40(6):511-24. doi: 10.1002/dc.22820. Review. — View Citation

Chandan VS, Zimmerman K, Baker P, Scalzetti E, Khurana KK. Usefulness of core roll preparations in immediate assessment of neoplastic lung lesions: comparison to conventional CT scan-guided lung fine-needle aspiration cytology. Chest. 2004 Sep;126(3):739- — View Citation

Dogan S, Becker JC, Rekhtman N, Tang LH, Nafa K, Ladanyi M, Klimstra DS. Use of touch imprint cytology as a simple method to enrich tumor cells for molecular analysis. Cancer Cytopathol. 2013 Jul;121(7):354-60. doi: 10.1002/cncy.21292. Epub 2013 Apr 10. — View Citation

Gupta NJ, Wang HH. Increase of core biopsies in visceral organs--experience at one institution. Diagn Cytopathol. 2011 Nov;39(11):791-5. doi: 10.1002/dc.21456. Epub 2010 Oct 19. — View Citation

Hahn PF, Eisenberg PJ, Pitman MB, Gazelle GS, Mueller PR. Cytopathologic touch preparations (imprints) from core needle biopsies: accuracy compared with that of fine-needle aspirates. AJR Am J Roentgenol. 1995 Nov;165(5):1277-9. — View Citation

Mangia A, Chiriatti A, Chiarappa P, Incalza MA, Antonaci G, Pilato B, Simone G, Tommasi S, Paradiso A. Touch imprint cytology in tumor tissue banks for the confirmation of neoplastic cellularity and for DNA extraction. Arch Pathol Lab Med. 2008 Jun;132(6) — View Citation

Padmanabhan V, Barkan G, and Nayar R. Cytopathology + More | Assessing needle core biopsy adequacy—survey of practices. http://www.captodayonline.com/assessing-needle-core-biopsy-adequacy-survey-practices-516/

Rekhtman N, Kazi S, Yao J, Dogan S, Yannes A, Lin O, Silk M, Silk T, Durack JC. Depletion of Core Needle Biopsy Cellularity and DNA Content as a Result of Vigorous Touch Preparations. Arch Pathol Lab Med. 2015 Jul;139(7):907-12. doi: 10.5858/arpa.2014-039 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cases with enough diagnostic features on the FNA smears and/or touch imprints of NCB.	All the cytology cases with rapid on site examination (ROSE) of FNA smears and/or touch imprints of needle core biopsies from January 1st/2011 to December 31st/ 2017, will be retrieved using the University of Mississippi Medical Center's Pathology Laboratory information system (Copath). The investigators will review the cases and get a number of cases with enough diagnostic features (based on the cytomorphologic features of the cells, quality of the smears and touch imprints, and the cellularity) on each case.	January 2011 to December 2017