1. What data in particular will be shared?
   Response (Others) - 


2. What additional supporting information will be shared?
   Response - Informed Consent Form
   
   
3. Who will be able to view these files?
   Response - Researchers who provide a methodologically sound proposal.
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [drswatipriya6801@gmail.com].
   


6. For how long will this data be available start date provided 25-06-2028 and end date provided 25-06-2032?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Title of the project
COLPOSCOPY VERSUS PAP SMEAR FOR CERVICAL CANCER SCREENING IN HIGH RISK TRIBAL WOMEN  A HOSPITAL BASED STUDY
Aim To compare the accuracy of colposcopy using Swede score and Pap smear for the detection of premalignant and malignant lesions of the cervix taking histopathology as gold standard  in high risk tribal women
Objectives
Primary
To compare the accuracy of Swede score aided colposcopy and Pap smear taking histopathology as reference standard in high risk tribal women
Secondary
To estimate the prevalence of premalignant and malignant cervical lesions in high risk tribal women
Justification for study
Exfoliative cytology HRHPV DNA test and visual inspection tests have been widely used as primary screening tests of cancer cervix Colposcopy has till now been used to guide the biopsy site The women with abnormal exfoliative cytology report and positive HRHPV test are referred for colposcopy However it has been observed that women with chronic cervical lesions are reported false negative on papanicoloau smear which is the most widely available and used screening test till date  Colposcopy using swede score is very accurate investigation which detects HGL and malignant lesions with about 95 100 sensitivity in the background of inflammatory changes specificity 80 88  So colposcopy should be done in all symptomatic patients with chronic cervical lesions like chronic cervicitis erosion endocervicitis lacerations polyps and leukoplakia Pap smear can be masked by inflammation in chronic cervicitis  making colposcopy a better choice for cervical cancer screening in these cases of unhealthy cervix These lesions have been observed to harbour premalignant lesions even when a Pap smear is negative  Also there is scarcity of information and dearth of literature related to cervical cancer screening and prevalence in indigenous women In todays world of advancement colposcopy if used judiciously can accurately screen and treat premalignant lesions of the cervix at the same setting for cervical cancer control in underprevilaged indigenous areas
Scope of the Project
Cervical cancer is one of the leading cause of morbidity and mortality in women especially in the developing countries despite being a preventable disease Early detection and diagnosis is the mainstay of cervical cancer control Exfoliative cytology is the most commonly used screening method till date The women with abnormal test are referred for colposcopy However it has been observed that chronic cervical lesions harbouring premalignant lesions are likely to be missed by Pap test and are reported false negative In chronic inflammatory lesions Pap smear can be masked by underlying inflammation making colposcopy a better choice The false negative rate of Pap smear had been reported as low as 2  earlier but as high as 47 in recent times So colposcopy should be used for screening these cervices so that premalignant lesions are not missed in the background of inflammation If null hypothesis is refuted the use of colposcopy as a primary screening tool in women at high risk of cancer cervix would be proven and utilized with improved portable technology telemedicine and artificial intelligence Also the treatment of abnormal cervices in the same setting facilitates expedited management and better patient satisfaction and overcomes the attrition risk This would be helpful for cervical cancer control in underprevilaged region as in this study This is synchronous with the WHO global strategy to accelerate the elimination of cervical cancer as a public health problem
Details of procedure and methodology proposed to be
Study population
The study will be conducted in 150 high risk women aged 21 to65 years attending gynecology outpatient department of AIIMS Deoghar Deoghar is one of the six districts of Santhal Pargana in Jharkhand with population of over 6 million Women having two or more risk factors of the following and at least one of the following examination finding will be classified as high risk and would be included in the study
In history
Complain of postcoital bleeding
Complain of postmenopausal bleeding
Complain of persistent discharge per vaginum
On examination
 cervical erosion
 laceration
polyp
leukoplakia
chronic cervicitis
Study setting
This will be a hospital based study on tribal women visiting gynecology out patient department in All India Institute of Medical Sciences Deoghar The study participants will be recruited by consecutive purposive sampling
Study design
This will be a prospective observational study
 
Sample size
Sample size is 150
Pap smear and colposcopy will be done in all participants
 
Inclusion criteria
Age 21 65 years
Not undergone treatment for cervical cancer or and precancer in the past
history of postcoital bleeding postmenopausal bleeding persistent discharge per vaginum with abnormal looking cervix polyp cervical lacerations leukoplakia erosion chronic cervicitis on examination
Consenting patients
Exclusion criteria
Pregnant women
Frank cervical cancer growth
Diagnosed case of cervical cancer precancer
Women undergoing treatment for gynecological cancer
 
Primary outcome
Colposcopy compared to Pap results in high-risk women with histopathology reference
 
Secondary outcome
Prevalence of cervical premalignant and malignant lesions in high risk women
 
 
Statistical analysis
The clinical records will be entered in the proformas The proformas used for data collection will be allocated serial numbers for data entry The data will then be entered in Microsoft access database after partial cleaning After partial cleaning it will be migrated to SPSS software Data analysis will be carried out The results of colposcopy and pap smear will be recorded separately and compared with histopathology as the gold standard The results of the study will be compared with prior relevant literature The prevalence of cervical cancer in women with cervical lesions will be estimated
DATA COLLECTION
A pre structured questionnaire will be administered to all women aged 21 to 65 years of age visiting AIIMS Deoghar out patient department. In questionnaire proformas detailed clinical history will be recorded regarding symptoms of abnormal bleeding vaginal discharge abdominal pain demographics sexual history obstetric history and past history Gynecological examination will be done in all women and those with abnormal looking cervix will be identified All high risk women will be explained about the nature and purpose of tests in the local language Subject information material and consent forms will be read out to the participants before obtaining their signature on the consent forms Those women who deny informed consent will be excluded All participants will undergo pap smear colposcopy and guided biopsy in the same visit Cervical cytology smears cervical biopsies and endocervical tissue will be processed and diagnosed in the Department of Pathology AIIMS Deoghar
The pap smear examination will be done according to the standard protocol. The ectocervical smear will be collected by Ayres spatula and endocervical sample will be collected using cytobrush The monolayer cytology smear will be fixed in 95 ethanol for processing. The cytology smears will be reported according to the Bethesda system 2014 The participants with Pap test results of atypical squamous cells with undetermined significance ASCUS atypical squamous cells cannot exclude high grade lesion ASCH atypical glandular cells AGC low grade squamous intraepithelial lesion LSIL high grade squamous intraepithelial lesion HSIL atypical glandular and or atypical endocervical cells will be classified as abnormal Pap smear
Colposcopy will be performed using a video colposcope Digital video colposcope Sims and recorded according to 2011 IFCPC nomenclature normalabnormal The cervix will be inspected in good light Saline will be applied to remove any discharge or mucus Any area of leukoplakia present will be noted Then 5 freshly prepared acetic acid will be applied liberally over the cervix using cotton After 1 minute of application entire cervix will be examined under magnification ranging 5 25 times Any abnormal acetowhite areas will be noted. A record will be made of the transformation zone TZ TZ will be labelled as type 1 if new squamocolumnar junction is fully visualized type 2 if TZ is partially visualized and type 3 if TZ is not visualized After that lugols iodine will be dabbed onto cervix Any area of nonuptake appearing as mustard or canary yellow will be noted. Swede scoring will be done with five recorded variables acetowhite areas margins abnormal vessels iodine negativity and lesion size Biopsy will be taken from most abnormal area using punch biopsy forceps For unhealthy cervical lesions appropriate treatment as per standard guidelines will be administered in all participant women For colposcopy the paticipants with swede score 0 to 4 will be considered low grade lesions and swede score 510 will be considered high grade lesions or malignancy on colposcopy
 Detailed time line for the project
 
The type of biopsy will be taken as per standard treatment care. Histopathological findings will be described according to OSSN classification Benign report will be recorded in specimens with no atypia Cervical Intraepithelial neoplasia CIN if mild moderate and severe will be described as CIN1 CIN2 and CIN3 respectively Invasive cancer will include malignant cells invading basement membrane The methodology is summarized in Figure 1
 
 DATA analysis
The clinical records will be entered in the proformas The proformas used for data collection will be allocated serial numbers for data entry The data will then be entered in Microsoft access database after partial cleaning After partial cleaning it will be migrated to SPSS software Data analysis will be carried out The results will be expressed as mean value plus minus standard deviation or proportions Colposcopy and pap smear will be the two index tests for comparison of diagnostic accuracy parameters Histopathology will be taken as the reference standard test. ROC analysis will be done for comparing sensitivity specificity predictive values accuracy and other parameters using histopathology as the gold standard AUC point 9to 1 will indicate excellent diagnostic accuracy and AUC between point 8 and point 9 very good accuracy point 7 to point 8 good point 6 to point 7 sufficient and if AUC is less than point 5 test will not be useful The results of the study will be compared with prior relevant literature
Additionaly the diagnostic parameters of pap smear and colposcopy different histopathology, will also be compared separately using 22 tables The prevalence of cervical cancer in women with cervical lesions will be estimated
 This project is for three years
 
 
 
Limitations
 As this is a prospective observational diagnostic accuracy study design involving three procedures and reporting the risk of information bias will be there to some extent Clinical reporting and histopathological reporting and statistical analysis may be affected by clinical data and symptoms Selection bias may be there to some extent
Both selection and information bias may be overcome by randomized control study design
Adverse events in participants though very rare if occur will be managed as per the standard guidelines
With 604127 cases every year and 341831 deaths cancer cervix is the fourth most common cancer affecting women worldwide 1 Majority of cases are still reported from developing countries despite widespread screening and treatment programmes One women dies of cervical cancer every eight minutes in India despite cancer cervix being a largely preventable disease The primary prevention methods namely vaccination and screening are effective measures to prevent the disease progression
Cytology by Papanicolau test High Risk Human Papilloma Virus testing visual inspection by Acetic acid  and Visual inspection by Lugols Iodine  are commonly used primary screening tests for cancer cervix. Pap smear was considered to be 80 to 95 accurate for detection of premalignant and early invasive cervical cancer More recently the reported accuracy of Pap smear was challenged due to false negative Pap reports in cases of unhealthy cervix especially chronic cervicitis endocervicitis cervical polyps leukoplakia erosions lacerations and lesions bleeding on touch 2 3 4 The false negative rate of Pap smear had been reported as high as 47 and specificity as 74 in recent times 5  However till date it is the most commonly used screening test During the process of collection of smear acetic acid and schillers test without magnification or direct colposcopy can be planned in case of suspicious or unhealthy cervix This is particularly important in early diagnosis and administration of treatment see triage and treat in those cases which may result in false negative pap test result The Pap test is the recommended cervical cancer screening test of choice of national colposcopy and cervical pathology organisations worldwide Cervical cytology has the added advantage of direct inspection of cervix by health care personnel unlike the HRHPV test Visual inspection tests have limited accuracy and thus limited to low re source settings HRHPVPV test have the advantage of self sampling and thus broad coverage but limited specificity especially in younger woman
Colposcopy has been traditionally used for the diagnosis of precancerous lesions It has been used as an adjunct to screening as a secondary triage screening tool The purpose of colposcopy is largely limited to direct biopsies from abnormal areas in screen positive women
Women with chronic cervical lesions like chronic cervicitis endocervicitis cervical erosions lacerations polyp leukoplakia harbor premalignant lesions Exfoliative cytology may be reported as normal in them The false negative rate of Pap smear had been reported as low as 2 earlier but as high as 47  in recent times 5 6 So evaluation under magnification acetic acid application and directed biopsy in colposcopy clinics is of great value in women with unhealthy looking cervix Histopathology has been used as gold standard for comparison of two groups in women with unhealthy cervices 7 8 9
 
REFERENCES
1 Sung H et al Global cancer statistics 2020 GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries CA cancer J Clin 2021 May
2 Singh Ls Dastur NA Nanavati MS A comparison of colposcopy and papanicolaou smear sensitivity specificity and predictive value
3 Gupta SC Evaluation of cervical erosion in symptomatic women Int J Reprod Contracept Obstet Gynecol 2020
4 Fuke RP Sonak M Singh M Role of colposcopy in the evaluation of unhealthy cervix and cervical intraepithelial neoplasia J Evid Based Med Healthcare 2020
5 Bhattacharya AK Nath JD Deka H Comparative study between Pap smear and visual inspection with acetic acid in screening of CIN and early cervical cancer J Midlife Health April  2015
Oglan SC Obut M Comparison of Pap smear and Colposcopy in the absence of HPV test for the diagnosis of Premalignant and Malignant cervical lesions East J Med 2020
7 Can LBC Completely Replace Conventional Pap Smear in Developing Countries J obs and Gynae India 2019
8 Rahman Z Yadav G Tripathi U The Diagnostic Efficacy of Swede Score for Prediction of Preinvasive Cervical Lesions A Prospective HospitalBased Study J Obstet Gynaecol India 2020 Dec
9 Campos PL Guimares ICCDV Fialho SCAV Martins CAO Rodrigues FR Velarde LGC Monteiro DDSA Association of Swede Score and 2011 IFCPC Nomenclature in Women with Abnormal Cytology