| 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
|
|
|
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. |