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CTRI Number  CTRI/2024/11/077500 [Registered on: 29/11/2024] Trial Registered Prospectively
Last Modified On: 28/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Expression of E6 and E7 among precancerous and cancerous lesions cervix  
Scientific Title of Study   To determine the expression of E6 and E7 in precancerous and cancerous lesions of cervix by using Immuno-histochemistry: An Observational Study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vidushi joshi 
Designation  Junior Resident 
Affiliation  AIIMS Bathinda 
Address  Room 214 First Floor D Block Department of Pathology AIIMS BATHINDA BATHINDA

Bathinda
PUNJAB
151001
India 
Phone  9131637674  
Fax    
Email  vidjoshe27@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Manjit Kaur Rana 
Designation  Additional Professor 
Affiliation  AIIMS Bathinda 
Address  First Floor D Block Department of Pathology AIIMS BATHINDA BATHINDA

Bathinda
PUNJAB
151001
India 
Phone  8427950069  
Fax    
Email  drmrsmanjitkaur@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vidushi joshi 
Designation  Junior Resident 
Affiliation  AIIMS Bathinda 
Address  Room 214 First Floor D Block Department of Pathology AIIMS BATHINDA BATHINDA

Bathinda
PUNJAB
151001
India 
Phone  9131637674  
Fax    
Email  vidjoshe27@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Bathinda Mandi dabwali road Bathinda 151001 
 
Primary Sponsor  
Name  AIIMS Bathinda 
Address  AIIMS Bathinda Mandi Dabwali Road Bathinda 151001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
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 Vidushi joshi  AIIMS Bathinda  D Block Department of Pathology AIIMS BATHINDA BATHINDA
Bathinda
PUNJAB 
9131637674

vidjoshe27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS bathinda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1. Patients with age more than 18 years

2. Patients with precancerous and cancerous lesions of cervix

3.Patients who have given their consent. 
 
ExclusionCriteria 
Details  1. Patients with age less than 18 years
2. Inadequate/Non representative sampling
3. Non neoplastic lesions on histopathology 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Expression of E6 and E7 on preoperative cervical biopsy   At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Expression of p16 in preoperative cervical biopsy & comparison with E6 & E7 expression   At Baseline  
 
Target Sample Size   Total Sample Size="31"
Sample Size from India="31" 
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)   15/12/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
In India, cervical cancer ranks as the second most common malignancy among women overall
and among those between the ages of 15 and 44. Approximately 5.0% of women in the general
population are infected with HPV-16/18 at any given moment, and HPV s 16 or 18 are the cause
of 83.2% of invasive cervical malignancies. (1). Persistent high-risk genital HPV infection
accounts for approximately 99.7% of cases of cervical cancer. (2)
Yamato et al., 2008; Jabbar et al., 2009 stated that HPV E6 and E7 viral oncoproteins play the
important role in oncogenesis. During the process of replicating the viral genome induce all the
hallmarks of a cancer cell like uncontrolled cellular proliferation, angiogenesis, invasion, metastasis, and unrestricted telomerase activity and evasion of apoptosis and growth suppressors’ activity. E6 degrade p53 through ubiquitination and cause continuous cell proliferation. In
normal cells RB plays important role in regulating the G1-S checkpoint of the cell cycle. In HPV
infected cells the E7 targets the Rb phosphorylation by cyclin D-CDK4, cyclin D-CDK6 leading
to the release of E2F transcription factor. Then the latter activates transcription of S-phase genes
forcing the cells through premature S phase entry. E7 also triggers the expression of
p16(CDKN2A) through RB disintegration and also epigenetic derepression through KDM6B.P16 normally acts as tumor suppressor gene but in HPV infected cells it exhibits oncogenetic activity. But p16 is not exclusively increased in cervical carcinoma, it is increased in wide variety of tumors such as pancreatic, esophageal and head neck carcinoma. So, p16 alone cannot be used as it is nonspecific .Other less invasive methods for screening for cervical cancer include liquid-based cytology and RTPCR. In affluent nations, cervical cancer cases can be effectively controlled with these cytological screening techniques. But these kinds of screening systems are not practical in middle-class or lower-class nations like India. RTPCR and LBC equipment accessibility and a shortage of qualified professionals are obstacles that impact cytological screening programs. So, E6 and E7 expression on immunohistochemistry is a better option. There are proven studies of E6 and E7 expression on head and neck squamous cell carcinoma and oropharyngeal carcinoma caused by HPV and very few on cervical carcinoma. No study could be retrieved from the literature on E6 and E7 protein in cervical carcinoma cases using IHC in India.
 
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