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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: D013||Carcinoma in situ of anus and analcanal, |
|
Intervention / Comparator Agent
|
|
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. |