Thesis Protocol New

VERSION 1.0 DEPARTMENT OF PATHOLOGY, SETH GSMC & KEMH

PROTOCOL FOR DISSERTATION

TITLE-fine needle aspiration cytology of papillary lesion of breast 6 year

retrospective study.

INSTITUTE

DEPARTMENT OF PATHOLOGY, SETH G.S.MEDICAL COLLEGE AND KEM

HOSPITAL, MUMBAI.

INVESTIGATORS

POST-GRADUATE GUIDE (PRINCIPAL INVESTIGATOR)

DR. LEENA NAIK (PROFESSOR)

DEPARTMENT OF PATHOLOGY

SETH G.S. MEDICAL COLLEGE AND KEM HOSPITAL, MUMBAI.

POST-GRADUATE STUDENT (CO-INVESTIGATOR)

DR.GARIMA VIJAYVERGIYA(RESIDENT)

DR.KANCHAN KOTHARI (ASSOCIATE PROFESSOR)

DEPARTMENT OF PATHOLOGY

SETH G.S. MEDICAL COLLEGE AND KEM HOSPITAL, MUMBAI.


INDEX

TOPIC PAGE NO.

Introduction 1

Aims and Objectives 2

Materials and Methods 2-3

References 4

ATTACHMENTS

1 .Summary of protocol

2.Case record form


INTRODUCTION :-

Papillary lesions of the breast are a heterogeneous group of breast

lesions. Cytological interpretation of papillary lesions of breast is a difficult task. These lesions

have risk of false-positive diagnosis .These lesions have varied morphologic features that carry

different prognosis. Accurate diagnosis is required to ensure that effective treatment is achieved.

These lesions present clinically as a mass or nipple discharge without a clinically evident lump.

Papillary lesions of the breast include:-

1. papillary hyperplasia in fibrocystic disease

2. benign papilloma

3.malignant papillary lesions including micropapillary, intracystic and invasive papillary

carcinoma.

Papillomas of the breast can be divided into solitary papillomas, multiple papillomas, and

juvenile papillomatosis

Papillary carcinoma is rare, constituting 12% of breast cancer. it can be noninvasive or invasive

papillary carcinoma and invasive micropapillary carcinoma.. The noninvasive form may extend

throughout a ductal system (intraductal) or may be confined within a cystic structure (intracystic).

Rationale-. papillary lesions of breast are wide spectrum of disease. It includes benign as

well as malignant papillary lesions. It is difficult to differentiate between benign and

malignant papillary lesions as it has overlapping cytomorphological features. sometimes

degenerative changes also mimic malignancy . We are carrying out this study, to find out

difficulties faced in diagnosis of papillary lesions of breast, so as to improve dianostic

accuracy.

Parameters that will be used to determine utility of FNAC for diagnosing papillary lesions

of breast:-

1.background-Blood,calcification,single scattered columnar cells, hemosiderin laden

macrophages ,myoepithelial cells.


2.Cellular features-Cellularity, dissociation, nuclear atypia, nuclear pseudoinclusions, cell

morphology,e.g.,apocrine,columnar

3.Tissue fragments-Long finger-like branching fragment(complex vs.simple branching,presense

of fibrovascular cores),complex fragments,other than papillary,cellular balls,single detached

papillae,tiny tongue like projections.

AIMS AND OBJECTIVES

This will be a 6 year retrospective study dealing with:

1) Utility of Fine Needle Aspiration Cytology (FNAC) in diagnosis of papillary lesions of

breast

2) To determine the cytomorphological spectrum of the papillary lesion of breast FNAC

3) To correlate Fine Needle Aspiration Cytology finding of cases diagnosed as papillary

lesion of breast with histopathology

4) To determine diagnostic accuracy of the FNAC in the diagnosis of papillary lesion

5) To find incidence of false positive and false negative cases


MATERIALS AND METHODS

This will be a 6 year retrospective study

Inclusion criteria-all the case which have been diagnosed as papillary lesion on FNAC

and also all the lesions which are diagnosed as papillary lesions of breast on

histopathology, which have not been diagnosed as papillary lesion on FNAC.So false

negative test would not be missed.

Exclusion criteria-Lesions diagnosed as non papillary lesions on both FNAC and

histopathology.

Clinical history & notes of 75 patients will be obtained from the databases of cytology

section in Department of Pathology, Medical record department and surgical

histopathology section.

The FNAC slides obtained by aspiration and non aspiration technique, stained with

Giemsa and PAP stain will be retrieved and studied.

The cases will be analysed based on the cytological features and correlated with

histopathological records.

Sensitivity, specificity, positive and negative predictive value will be calculated.

Statistical analysis will be performed by using software programme available for the

same known as SPSS (Statistical Package for Social Sciences).

FORMULAS-

Sensitivity-True positive/true positive+false negative

Specificity-Truel negative/false positive+true negative

Positive predictive value-True positive/true positive+false positive

Negative predictive value-True negative /true negative+false negative

Where the False negative cases - which are diagnosed non papillary on FNAC and

diagnosed as papillary on histopath.


False positive cases - which are diagnosed as papillary on FNAC and non papillary on

histopathology.

False negative test for malignancy- when in FNAC lesion diagnosed as benign and on

histopathology diagnosed as malignant.

False positive test for malignancy-when in FNAC lesion diagnosed as malignant and on

histopathology diagnosed as benign.

OBSERVATION:

Cytological findings will be correlated with Histopathological

records. Incidence of various lesions will be studied.

All the cases

1. cases diagnosed as papillary lesions on FNAC will be on histopathology follow up.

2. Cases diagnosed as nonpapillary on FNAC but diagnosed as papillary on histopath

examination.

3. All the cases which were diagnosed as papillary lesion on FNAC, but revealed as

non-papillary on further histopathological examinations will be studied in detail.

Slides will be retrived and various variant of papillary lesion will be studied.

Sensitivity, specificity, positive and negative predictive value will be calculated.

Statistical analysis will be performed by using software programme available for the

same known as SPSS (Statistical Package for Social Sciences).


RREEFFEERREENNCCEESS

1.D Prathiba, Shalinee Rao, [...], and Leena Dennis Joseph Papillary lesions of breast An

introspect of cytomorphological features Jcytol jan 2010,27(1) :12-15

2.Nayar R, De Frias DV, Bourtsos EP, Sutton V, Bedrossian C. Cytological differential diagnosis of

papillary pattern in breast aspirates: Correlation with histology. Ann Diagn Pathol. 2001;5:34

42. [PubMed]

3.Tse GM, Ma TK, Lui PC, Ng DC, Yu AM, Vong JS, et al. Fine needle aspiration cytology of

papillary lesions of the breast: How accurate is the diagnosis? J Clin Pathol. 2008;61:9459.

[PubMed

4.Reid-Nicholson MD, Tong G, Cangiarella JF, Moreira AL. Cytomorphologic features of papillary

lesions of the male breast: a study of 11 cases. Cancer. 2006;108:222230

5.Jeffrey PB, Ljung BM. Benign and malignant papillary lesions of the breast. A

cytomorphological study.Am J ClinPathol.1994;101:500-507

6.Michael CW, Buschmann B. Can true papillary neoplasms of

breast and their mimickers be accurately classified by cytol-

ogy?Cancer (Cancer Cytopathol).2002;96:92100


SUMMARY

Papillary lesion of breast encompass wide spectrum of lesions both benign and malignant. It

constitutes 1-2% of cases. These lesions have varied clinical, radiological features which causes

diagnostic difficulties.

This retrospective study of 6 years, will highlight the spectrum of cytomorphological findings of

papillary lesion of breast.

Clinical, and histopathological correlation will help to assess sensitivity, specificity, accuracy,

positive and negative predictive value of FNAC in diagnosing papillary lesion of breast.


CASE RECORD FORM

Date

Pathology number:- Registration number :-

Age: - Sex:-

Clinical Presentation:-

Investigations:-

(I) SONOGRAPHY

(II) MAMMOGRAPHY

(III) Other relevant investigations

Description of lesion:-

Gross findings:-

Microscopic findings:-

1.Cytological ii) Histopathological

Final Impression:-

Principal investigator:-


CASE RECORD FILE

Sr. No. Patholog

y No.

Age Sex Registrat

ion No.

Descript

ion of

the

lesion

Cytologi

cal

diagnosi

s

Histopat

hologica

l finding

Sonogra

phic

finding

Mammo

graphic

finding

1.

2.

3.

4.

5.

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