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CTRI Number  CTRI/2019/08/020610 [Registered on: 07/08/2019] Trial Registered Prospectively
Last Modified On: 05/08/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective observational study 
Study Design  Other 
Public Title of Study   Screening for early anal cancer among men having sex with men 
Scientific Title of Study   Screening for anal intraepithelial neoplasia among men having sex with men attending a designated Sexually Transmitted clinic in South India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M Malathi 
Designation  Associate Professor  
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) 
Address  Department Of Dermatology and STD Jawaharlal Institute Of Postgraduate Medical Education and Research (JIPMER) Dhanvantari Naga, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  7373842888  
Fax    
Email  mmalathi.dr@live.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M Malathi 
Designation  Associate Professor  
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) 
Address  Department Of Dermatology and STD Jawaharlal Institute Of Postgraduate Medical Education and Research (JIPMER) Dhanvantari Naga, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  7373842888  
Fax    
Email  mmalathi.dr@live.com  
 
Details of Contact Person
Public Query
 
Name  Dr M Malathi 
Designation  Associate Professor  
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) 
Address  Department Of Dermatology and STD Jawaharlal Institute Of Postgraduate Medical Education and Research (JIPMER) Dhanvantari Naga, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  7373842888  
Fax    
Email  mmalathi.dr@live.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research ICMR V. Ramalingaswami Bhawan, Ansari Nagar, Post Box Bo. 4911 New Delhi - 110029 
 
Primary Sponsor  
Name  Indian Council of Medical Research ICMR 
Address  V. Ramalingaswami Bhawan, Ansari Nagar, Post Box Bo. 4911 New Delhi - 110029 
Type of Sponsor  Government funding agency 
 
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 
Dr M Malathi  Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER  OPD No:85, Dermatology and STD Old Hospital Block (2nd floor)
Pondicherry
PONDICHERRY 
7373842888

mmalathi.dr@live.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Human Studies)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D013||Carcinoma in situ of anus and analcanal,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Male 
Details  Consecutive consenting men aged more than or equal to 18 years, attending the “Suraksha clinic” of the dermatology OPD of JIPMER identifying their sexuality as MSM (includes homosexual and bisexual men). 
 
ExclusionCriteria 
Details  Patients with known anal cancer
Patients with fissure in ano and fistula in ano
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Frequency of anal intraepithelial neoplasia and its epidemiologic correlates

Diagnostic accuracy of anal “Pap” smears with p16 immunostaining, human papilloma virus (HPV) detection, and HRA findings in comparison with HRA guided biopsy findings as gold standard to detect anal intraepithelial neoplasia
 
At recruitment
 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="308"
Sample Size from India="308" 
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)   02/09/2019 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Ø Men who have sex with men (MSM), is at greater risk for anal cancer and its precursor lesions when compared to men in the general population.

Ø Incidence of anal cancer in MSM has been reported to be higher than the incidence of cervical cancer in women with the highest rates among HIV positive MSM in whom anal cancer rates are the highest. 

Ø Almost upto 20% of patients with anal cancer are asymptomatic and the most common symptom reported is rectal bleeding which would be often attributed to haemorrhoids thereby further delaying the diagnosis. Epidemiologic studies have indicated that a             prolonged preclinical phase often precedes the onset of anal cancer in high-risk groups. 

Ø The basic principle behind screening for anal dysplasia is the early identification of these proliferating cell lines that have established irreversible high-grade dysplasia or local invasive disease.

Ø Hence providing screening methods, especially for high-risk individuals, would provide an opportunity for earlier diagnosis and management of HPV and associated cytologic changes. These screening methods include anal Pap smears often combined with digital anorectal examination (DARE), to detect both palpable anatomic lesions as well as cytologic abnormalities followed by HPV detection and high resolution anoscopy and biopsy.

Ø Anal Pap smears have been found to have a sensitivity of 69% to 93%, and  specificity of 32% to 59% and have been reported to be cost-effective in detecting abnormal lesions in high-risk patients.However, the role of HPV detection in anal dysplasia screening remains controversial.

Ø HPV related anal dysplasia and cancer is a public health concern, just like other sexually transmitted infections and currently there are no national recommendations available for their screening. Due to the high rates of anal dysplasia and cancer in MSM, this study is proposed to identify the prevalence of AIN and to implement an effective screening program for this high risk population.

Aim:

To study the usefulness of screening tests and propose a screening strategy for the detection of anal intraepithelial neoplasia (AIN) and its epidemiologic correlates among men having sex with men (MSM) attending a designated sexually transmitted infection (STI) clinic in South India. 

Objectives:

Among men having sex with men (homosexual and bisexual) attending a   designated STI clinic in South India,

1.     To study the frequency of anal intraepithelial neoplasia and its epidemiologic correlates.

2.     To study the diagnostic accuracy of anal “Pap” smears with p16 immunostaining, human papilloma virus (HPV) detection, and HRA findings in comparison with HRA guided biopsy findings as gold standard to detect anal intraepithelial neoplasia.

 

 
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