CYTOLOGY OF SKIN LESIONS
- Conditions
- bullous, infectious and neoplastic skin lesions
- Registration Number
- CTRI/2013/11/004156
- Lead Sponsor
- MENDONCA BRYNE SHAREL
- Brief Summary
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|**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 ofcytology 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**
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 30
clinical suspicion of leprosy,leishmaniasis,cutaneous neoplasms,secondaries and vesiculobullous lesions.
patients not willing for the cytological study and cases with inadequate cytological material.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2.To correlate clinical, cytological and histopathological findings of various skin lesions. 3 years and six months 1.To find out the utility of cytology as the first line investigation in evaluating skin lesions. 3 years and six months
- Secondary Outcome Measures
Name Time Method cytology as a diagnostic tool 3 years and six months
Trial Locations
- Locations (1)
department of pathology
🇮🇳Kannada, KARNATAKA, India
department of pathology🇮🇳Kannada, KARNATAKA, Indiamendonca bryne sharelPrincipal investigator09880236957brynedonca@gmail.com