| CTRI Number |
CTRI/2024/08/072693 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
15/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to compare the detection rate of E6/E7 gene in cervical samples of females with HPV infections, with their cervical biopsy results. |
|
Scientific Title of Study
|
Comparison of PCR based E6/E7 Oncogene detection in cervical cytology and cervical tissue specimen with histopathology in HPV-positive women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shaloo Priya |
| Designation |
Senior Resident (Academic) |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar East, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
8709906200 |
| Fax |
|
| Email |
shaloopriya24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Meena |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar East, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9953937130 |
| Fax |
|
| Email |
drjyotirajesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Meena |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar East, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9953937130 |
| Fax |
|
| Email |
drjyotirajesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Will apply for Thesis grant |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar East, New Delhi 110029 |
| Type of Sponsor |
Government medical college |
|
|
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 Shaloo Priya |
All India Institute of Medical Sciences, New Delhi |
Colposcopy Room, Department of Obstetrics and Gynaecology
New Delhi
DELHI |
8709906200
shaloopriya24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Women aged 30-65 years, who are tested positive for HPV DNA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison of E6/E7 test results in cervical cytology and biopsy specimen with histopathological report |
Each case will serve as its own comparator agent, where the test results of E6/E7 oncogene detection will be compared to their respective final histopathological report. |
| Intervention |
E6/E7 Oncogene detection in cervical cytology and cervical tissue specimen in HPV-positive women |
E6/E7 oncogene test results will be analyzed in relation to the HPV DNA positivity and the final histopathological results in every case individually and results will be compiled. The E6/E7 expression will also be correlated in exfoliative cytology as well as biopsy tissue samples. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Women aged ≥ 30 – 65 years
2. No previous history of cervical lesions or cervical cancer
3. Willing to participate in the study after informed written consent
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy
2. Inadequate cervical cytology/tissue sample
3. Active PID, genital infection, vaginal discharge
4. Previously treated for preinvasive or invasive lesions of cervix
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Compare the PCR based E6/E7 oncogene testing in cervical cytology to the histopathological diagnosis in HPV positive samples.
2. Compare the PCR based E6/E7 oncogene testing in cervical tissue to the histopathological diagnosis in HPV positive samples.
|
1. After getting test results
2. At the end of the study, by June 2026 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Compare E6 & E7 oncogene detection in cervical cytology & tissue samples with final histopathology results
2. Compare the E6/E7 oncogene detection rates in cervical cytology with HPV positivity
3. Compare the E6/E7 oncogene detection rates in cervical tissue with HPV positivity
|
1. After getting test results
2. At the end of the study, by June 2026
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
28/08/2024 |
| 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 Yet Recruiting |
| 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
|
Study hypothesis: HPV DNA presence cannot differentiate infectious state from pre-invasive/invasive cervical lesions, hence leading to more unnecessary interventions. Since integration of HPV DNA into the host cell genome is the key step in development and progression of cervical cancer, the detection of E6/E7 oncogenes can be used as a promising tool for triaging HPV positive women in detecting preinvasive lesions. In this study we will evaluate whether PCR based E6/E7 oncogene detection in cervical cytology and tissue samples help in diagnosing preinvasive lesions of cervix in HPV positive women, and will also evaluate the performance of E6 &7 oncogene detection as an optional triage for HPV positive women using cervical cytology and cervical tissue samples.
|