Diagnostic Efficiency of Touch Imprints Versus Smears

May 4, 2018 updated by: Maria F. Gonzalez, University of Mississippi Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of cases with enough diagnostic features on the FNA smears and/or touch imprints of NCB.
Time Frame: January 2011 to December 2017
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Mississippi Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2017

Primary Completion (Actual)

May 2, 2018

Study Completion (Actual)

May 2, 2018

Study Registration Dates

First Submitted

July 18, 2017

First Submitted That Met QC Criteria

July 19, 2017

First Posted (Actual)

July 21, 2017

Study Record Updates

Last Update Posted (Actual)

May 7, 2018

Last Update Submitted That Met QC Criteria

May 4, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017-0076

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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