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CTRI Number  CTRI/2013/11/004156 [Registered on: 20/11/2013] Trial Registered Retrospectively
Last Modified On: 15/11/2013
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   comparative 
Study Design  Other 
Public Title of Study   CYTOLOGY OF SKIN LESIONS 
Scientific Title of Study   CLINICAL AND CYTOHISTOPATHOLOGICAL STUDY OF SKIN LESIONS WITH SPECIAL REFERENCE TO BULLOUS, INFECTIOUS AND NEOPLASTIC SKIN LESIONS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MENDONCA BRYNE SHAREL 
Designation  POSTGRADUATE IN PATHOLOGY 
Affiliation  FATHER MULLER MEDICAL COLLEGE 
Address  FATHER MULLER MEDICAL COLLEGE HOSPITAL, KANKANADY, MANGALORE
FATHER MULLER MEDICAL COLLEGE HOSPITAL, KANKANADY, MANGALORE
Dakshina Kannada
KARNATAKA
575002
India 
Phone  09880236957  
Fax    
Email  brynedonca@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr HILDA FERNANDES 
Designation  HOD OF PATHOLOGY, PROFESSOR 
Affiliation  FATHER MULLER MEDICAL COLLEGE 
Address  FATHER MULLER MEDICAL COLLEGE HOSPITAL, KANKANADY, MANGALORE
FATHER MULLER MEDICAL COLLEGE HOSPITAL, KANKANADY, MANGALORE
Dakshina Kannada
KARNATAKA
575002
India 
Phone    
Fax    
Email  hilda67@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  MENDONCA BRYNE SHAREL 
Designation  POSTGRADUATE IN PATHOLOGY 
Affiliation  FATHER MULLER MEDICAL COLLEGE 
Address  FATHER MULLER MEDICAL COLLEGE HOSPITAL, KANKANADY, MANGALORE
FATHER MULLER MEDICAL COLLEGE HOSPITAL, KANKANADY, MANGALORE
Dakshina Kannada
KARNATAKA
575002
India 
Phone  09880236957  
Fax    
Email  brynedonca@gmail.com  
 
Source of Monetary or Material Support  
MENDONCA BRYNE SHAREL 
 
Primary Sponsor  
Name  MENDONCA BRYNE SHAREL 
Address  FATHER MULLER MEDICAL COLLEGE HOSPITAL, KANKANADY, MANGALORE 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
mendonca bryne sharel  department of pathology  father muller medical college hospital, kankanady, mangalore-575002
Dakshina Kannada
KARNATAKA 
09880236957

brynedonca@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  bullous, infectious and neoplastic skin lesions,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  cytology  skin scraping, slit smears ,fine needle aspiration and tzank smears 
Comparator Agent  histopatholgy   biopsy sections. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  80.00 Year(s)
Gender  Both 
Details  clinical suspicion of leprosy,leishmaniasis,cutaneous neoplasms,secondaries and vesiculobullous lesions 
 
ExclusionCriteria 
Details  patients not willing for the cytological study and cases with inadequate cytological material 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To find out the utility of cytology as the first line investigation in evaluating skin lesions.
2. To correlate clinical, cytological and histopathological findings of various skin lesions.
 
3 years and six months 
 
Secondary Outcome  
Outcome  TimePoints 
cytology as a diagnostic tool  3 years and six months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2011 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

BRIEF RESUME OF THE INTENDED WORK

6.1.NEED FOR THE STUDY                                          

            Various lesions affecting the skin range from non-specific dermatoses and inflammatory diseases to neoplastic changes of various components of the skin.  Fine needle aspiration cytology (FNAC) is a well recognized modality of diagnosis of various organ systems.[1] Although text books describe FNAC of skin lesions it has not become as yet widely practised, mainly because surgical excision and biopsy are relatively easy procedures. However, there are many cases in which an accurate diagnosis must be established and would be of significant value in selected patients like elderly persons with heart diseases or under systematic therapy, patients with multiple, extensive skin lesions in whom surgical treatment may cause complications, patients in whom more that 2-3 skin lesions occur at a considerable distance from each other on the head and neck, where restoration demands an extensive skin allograft.[3,6,7] The procedure is non-traumatic, safe, inexpensive and very well tolerated by the patients.[8] As an alternative to performing biopsy fine needle aspiration cytology and other cytological methods such as slit skin smears, scrape smears and imprint smears are minimally invasive methods with rapid results that can be used to diagnose the skin lesions. The aim of this study is to evaluate cytology as a quick non–invasive method for early diagnosis of skin lesions and to correlate clinical, cytological and histopathological findings.

 

 

 

6.2. REVIEW OF LITERATURE

            The role of cytology in diagnosis of skin lesions is controversial because they are easily available for excision. However with the ever increasing use of FNAC in clinical practice there is a need for detailed cytological description of the spectrum of various skin lesion and the problems during cytodiagnosis. In a study done by Sabir F, et al the sensitivity of cytology in diagnosing vesiculobullous lesions, granulomatous lesions and neoplastic lesions was 96, 88.2 and 88.9% respectively.[1]

         There are a few large series in the literature on the cytological findings of tumors of the skin adnexa, the accuracy rate in these reports varies from 61% to 81%.[2] A study done by Prayaga AK, et al showed that  Primary malignant  tumors of skin and adnexae are diagnosable on Cytology and clinical features are helpful in differentiating primary from metastatic tumors. Diagnosis should be based on cytological and clinical features such as large lesion size, longer duration, skin ulceration and local recurrences. Subtyping the tumor may not be possible and cytology will not help to diagnose local invasion and mitotic count but a preoperative cytodiagnosis can help the surgeons to plan their management and mode of treatment. [3]

         Skin biopsy is an invasive technique and in addition there is shrinkage of parasites in sections making it difficult to detect on histopathology than on smears, especially in dry smears of cutaneous leishmaniasis making FNAC an effective method of diagnosis.[4]

 

 

        Although FNAC only supplements histopathology, it has an excellent value in patients not willing to undergo biopsy and helps to classify the patients quickly into pauci or multi bacillary types of leprosy. [5]

         A Study done in The London Hospital by Brown et al. shows that Basal cell carcinoma which accounts for 1-3% of patients seen by dermatologists is confirmed by biopsy which is time consuming and has a long waiting period for the results. In comparison cytology is quick and has a high probability to give positive diagnosis allowing treatment to be instituted at the first consultation. [6]

          So to conclude, various studies prove that FNAC is rapid, safe, cost effective modality in determining the nature of palpable skin lesions and precludes more invasive and costly modes of investigations. It not only can diagnose skin lesions which are metastasis with known primaries but may also offer a clue to underlying malignancy in unsuspected cases [7]  or recurrence.

 

6.3. OBJECTIVES OF THE STUDY

1.      To find out the utility of cytology as the first line investigation in evaluating skin lesions.

2.      To correlate clinical, cytological and histopathological findings of various skin lesions.

 

MATERIAL AND METHODS

7.1  SOURCE OF DATA:

             Retrospective and prospective study of cytology samples from patients with skin lesions at Father Muller Medical College Hospital.

7.2  SAMPLE SIZE:

      A Minimum of 30 cases

DURATION OF THE STUDY:

           The study period will be three and half years. Retrospective study of one and half year from January 2011 to June 2012 and prospective study of two years from July 2012 to June 2014.

7.2 METHOD OF DATA COLLECTION:

·         A study of cytology samples for a period of 3.5 yrs from January 2011 to June 2014.

·         Detailed history of patients will be taken and physical examination findings recorded.

·         Skin scraping for superficial lesions, Slit smears for suspicious leprosy cases and FNAC’s for skin nodules will be done

·         Fresh vesicle or bulla will be selected and incised with scalpel, reflecting the roof of the bulla. Base of the blister scraped gently and material spread on a glass consist of wet slide.

·         The wet smears will be fixed in 100% methanol and stained with Papanicolaou stain.

·         The dry smears will be stained with May-Grunwald-Giemsa and Wright Giemsa stains

·         Special stains like Ziehl Neelsen stain, FITE and Toulidine Blue will also be used.

·         Paraffin embeded tissue will be sectioned and subjected to Haematoxylin and Eosin staining for histopathological study.

·         Cytological diagnoses will be compared with histopathological results wherever available.

·         Concordance rate between cytological and histopathological diagnosis will be    analysed.

SELECTION CRITERIA

a.      Inclusion Criteria

Patients of all the age groups with clinical suspicion of leprosy, leishmaniasis, cutaneous neoplasms, secondaries and vesiculobullous lesions.

b.      Exclusion criteria

·         Patients not willing for the cytological study.

·         Cases with inadequate cytological material.

  Design of study:

   Correlative study

  Statistical Analysis:

       Collected data will be analysed by frequency, percentage, sensitivity, specificity,   prediction values and by kappa statistics.

 

7.3 Does the study require any investigations or interventions to be conducted on patients or other humans.

            Yes

 

7.4 Has ethical clearance been obtained from your institution?

            Yes

 
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