Diagnostic Efficiency of Touch Imprints Versus Smears
Diagnostic Efficiency of Needle Core Biopsy Touch Imprints Versus Fine Needle Aspiration Smears at the Time of Rapid on Site Interpretation
1 other identifier
observational
47
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2017
CompletedStudy Start
First participant enrolled
July 18, 2017
CompletedFirst Posted
Study publicly available on registry
July 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2018
CompletedMay 7, 2018
May 1, 2018
10 months
July 18, 2017
May 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
Diagnostic efficiency of touch imprints of needle core biopsies vs smears of fine needle aspirations during rapid on-site interpretation
Eligibility Criteria
Any patient that has required a fine needle aspiration or needle core biopsy at UMMC to diagnose a lesion regardless of the age, sex or any other condition.
You may qualify if:
- \. Computerized tomography (CT)-Guided Fine needle aspiration (FNA) /Needle core biopsy (NCB) specimens from any site.2. Ultrasound (US) guided FNA/NCB.
You may not qualify if:
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Related Publications (8)
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.
PMID: 20960472BACKGROUNDAisner 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.
PMID: 22619126RESULTPadmanabhan 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/
RESULTRekhtman 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.2014-0392-OA. Epub 2014 Dec 18.
PMID: 25521802RESULTDogan 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.
PMID: 23576371RESULTMangia 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):974-8. doi: 10.5858/2008-132-974-TICITT.
PMID: 18517281RESULTHahn 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. doi: 10.2214/ajr.165.5.7572518.
PMID: 7572518RESULTChandan 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):739-43. doi: 10.1378/chest.126.3.739.
PMID: 15364750RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Maria F Gonzalez, MD
University of Mississippi Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 6 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of the department of pathology
Study Record Dates
First Submitted
July 18, 2017
First Posted
July 21, 2017
Study Start
July 18, 2017
Primary Completion
May 2, 2018
Study Completion
May 2, 2018
Last Updated
May 7, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share