Diagnostic Efficiency of Touch Imprints Versus Smears

NCT ID: NCT03224910

Last Updated: 2018-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-18

Study Completion Date

2018-05-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diagnostic Self Evaluation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Mississippi Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Maria F. Gonzalez

Assistant Professor of the department of pathology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maria F Gonzalez, MD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20960472 (View on PubMed)

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.

Reference Type RESULT
PMID: 22619126 (View on PubMed)

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/

Reference Type 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.

Reference Type RESULT
PMID: 25521802 (View on PubMed)

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.

Reference Type RESULT
PMID: 23576371 (View on PubMed)

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.

Reference Type RESULT
PMID: 18517281 (View on PubMed)

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.

Reference Type RESULT
PMID: 7572518 (View on PubMed)

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.

Reference Type RESULT
PMID: 15364750 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-0076

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.