NCT03224910

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

July 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2018

Completed
Last Updated

May 7, 2018

Status Verified

May 1, 2018

Enrollment Period

10 months

First QC Date

July 18, 2017

Last Update Submit

May 4, 2018

Conditions

Keywords

FNA, smears, imprints, ROSE

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

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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: 20960472BACKGROUND
  • 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.

  • 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/

    RESULT
  • 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.2014-0392-OA. Epub 2014 Dec 18.

  • 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.

  • 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):974-8. doi: 10.5858/2008-132-974-TICITT.

  • 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. doi: 10.2214/ajr.165.5.7572518.

  • 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):739-43. doi: 10.1378/chest.126.3.739.

Study Officials

  • Maria F Gonzalez, MD

    University of Mississippi Medical Center

    PRINCIPAL INVESTIGATOR

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

Locations