Proforma for Registration of Subject for Dissertation/Thesis

1) Name of the Candidate and
Address: / DR NIRANJAN J.
No 1/2 (2066) 16th ‘D’ Main HAL II stage Bangalore 560008
2) Name of the Institute / VYDEHI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE
BANGALORE
3) Course of study and subject / MD, PATHOLOGY
4) Date of admission / 30/05/08
5) Title of the Topic: / CERVICAL ACID PHOSPHATASE: EVALUATION AS AN ADJUVENT TO PAP SCREENING INCERVICAL CANCER DETECTION

6) Brief resume of the intended work:

6.1) Need for the study:Routine cervical smears screened by papanicolaou (pap) stained smears is the most cost effective and efficacious method of cancerscreening. thus decreasing the incidence and mortality from cervical cancer 1.However cervical smear screening has significant rates of false positive and false negative results 2, 3. To improve the detection of the precancerous cervical lesions a number of additional tests have been developed. One such attempt to improve upon the pap smear reporting of the several methods is cervical acid phosphatase (CAP),which appears to be most cost effective additional test and also decreases the false negative results 4since normal cervical epithelial cells are negative for acid phosphatase only immature squamous cells and neoplastic cells show CAP positivity4.Hence the need for present studies.

6.2) Review of literature: Pap test was introduced by George Papanicolaou in1948. The American Cancer Society (ACS) introducedand promoted the Pap test as a screening method fordetecting women at risk for cervical cancer3.In Bangalore the crude incidence rate of cervical carcinoma in1997 was 13.86. Studies have shown that 20% of new cancercases in the US have never had or had a negative Pap test within 3–5 years before disease progress5.Thehigh false negative rate (>10%) is the major obstacle ofPap test 3.

6.3) Aims and Objectives of the study:

1)To asses the utility of CAP-PAP as an adjuvant to PAP.

2)To asses the cost effectiveness of CAP/PAP

7) MATERIALS AND METHODS
7.1) SOURCE OF DATA: Patients attending OBG out patient department at Vydehi institute of medical sciences who are aged 25-60 years undergoingPAPcervical screening form the source of material.

Inclusion Criteria: 1) Women with noprevious PAP screening.

2)Women with normal previous PAP screening.

Exclusion Criteria: 1) Without consent for the test.

2) Previous PAP Positive by screening.

3) Known case of carcinoma cervix.

7.2) METHOD OF COLLECTION OF DATA: Healthy female patients attending OBG Dept for routine cervical screening are examined by the gynecologists,who take 2 PAP smear one is fixed in alcohol the other is air dried and the smears are sent to the cytology department. An informed consent is taken from the patients and procedure is non-invasive and no additional requirements are needed.

The alcohol fixed slides are stained as routine PAP, while the unstained slides are stained for Cervical acid phosphatase, which is a single-slide, double-staining procedure for demonstrationof CAP activity by visualizing using Azo-Dye-coupling reaction of naptholAS-BI Phosphate/Fast Garnet system ,on the background of a modified Papanicolaoustaining2.The stained smears are reported by two separate cytopathologists as per 2001 Bethesda System.

7.3) Does the study require any investigation or interventions to be conducted on patients or other humans or animals? If so please describe briefly.

PAP smears are to be taken from the patents by the gynecologist in the OPD. No other tests are required.

7.4) Has Ethical clearance been obtained from your institution in case of 7.3: YES

8)LIST OF REFERENCES

  1. Bristow RE, MontzFJ. Workup of the abnormal Pap test. Clin Cornerstone 2000; 3:12-24.
  2. Markovic O, Markovic N. Can acid phosphatase reduce pap test false-negative readings? J Natl Cancer Inst 1997; 89: 1459.
  3. O Merkovic, N Markovic :Cervical acid phosphatase :A biomarker of cervical endpoint for colposcopy Disease Marker Vol 19 Nov 6/2003,2004 Page 279- 286
  4. Prabal Deb, Venkateswaran K.Iyer, Neerja Bhatla, Markovic O2 , Kusum Verma et al Cervical acid phosphatase detection: A guide to abnormal cells in cytology smear screening for cervical cancer Journal of cytology/ Jan2008 Volume 25/ Issue 1
  5. CDC Report: Incidence of Pap test abnormalities Within 3 Years of Normal Pap Test – United states, 1991-1998M<WR, 49(2000), 1001-1003 (
  6. ( to 34.pdf)

9)SIGNATURE OF CANDIDATE:
10)REMARKES OF THE GUIDE:
11)NAME AND DESIGNATION OF
GUIDE
SIGNATURE
CO-GUIDE
SIGNATURE
HEAD OF THE DEPARTMENT
SIGNATURE
REMARKES OF THE CHAIRMAN AND PRINCIPAL
SIGNATURE

FORMAT FOR PATIENT DETAILS /CONSENT FORM

IP/OP NO……………..

LAB NO…………………..

NAME OF THE PATIENT AND ADDRESS
AGE/SEX
OCCUPATION, EDUCATION, SOCIO -ECONOMIC STATUS.

I have been explained about the procedure in my own language and I here by unreservedly and in my full senses voluntarily to give consent/authorization for the collection of necessary tests material (PAP Smear) deemed necessary for the required research study.

I under stand that the test conducted are research / study oriented and that I will not be getting any test result.

Date……………….. Patient Signature…………………

FOR MEDICAL USE ONLY

HISTORY
Present symptom
Menstrual history
Any H/O previous surgery, treatment
Per speculum / Per vaginal examination
Colposcopy
Clinical Diagnosis
Other investigation’s

Unit No……………………

Doctor signature……………………..

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