| CTRI Number |
CTRI/2025/04/084075 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective Study |
| Study Design |
Other |
|
Public Title of Study
|
A Retrospective Study on Comparing Different Cervical Cancer Screening Methods and Factors Linked to HPV Infection in a Tertiary Cancer Clinic
|
|
Scientific Title of Study
|
A retrospective study audit for the comparative performance evaluation of Cervical Cancer
screening methods of Visual Inspection with Acetic acid, Cervical Cytology, HPV DNA testing
and Determinants of HPV Infection for detecting Cervical precancer/ cancers in a Tertiary
Cancer Screening Clinic |
| 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 Sharmila Pimple |
| Designation |
Professor and Head |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Preventive Oncology
3rd floor, Service block
Tata Memorial Hospital
Dr Ernest Borges road Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9223207939 |
| Fax |
|
| Email |
pimplesharmila@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharmila Pimple |
| Designation |
Professor and Head |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Preventive Oncology
3rd floor, Service block
Tata Memorial Hospital
Dr Ernest Borges road Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9223207939 |
| Fax |
|
| Email |
pimplesharmila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharmila Pimple |
| Designation |
Professor and Head |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Preventive Oncology
3rd floor, Service block
Tata Memorial Hospital
Dr Ernest Borges road Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9223207939 |
| Fax |
|
| Email |
pimplesharmila@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital Department of Preventive Oncology 3rd floor, Service block Tata Memorial Hospital Dr Ernest Borges road Parel, Mumbai400012, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Sharmila Pimple |
Tata Memorial Hospital |
Tata Memorial Hospital Department of Preventive Oncology
3rd Floor Service Block Building
Tata Memorial Hospital
Dr E Borges Marg
Mumbai 400012
Mumbai
MAHARASHTRA |
09223207939
pimplesharmila@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 18 years above
Women who Underwent cervical cancer screening by VIA, cytology and HPV DNA test
Women Underwent diagnostic evaluation by Colposcopy |
|
| ExclusionCriteria |
| Details |
Inadequate data despite the attempt will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Prevalence and Determinants Of HPV infection & CIN:
a. proportion of screened women testing positive for HPV infection.
b. Prevalence of different grades of cervical Intraepithelial Neoplasia (CIN1, CIN2, CIN3)
c. Association of Socio-demographic, clinical, and behavioral factors with HPV infection and CIN.
2. HPV Genotype Distribution and Association with Cervical Lesions:
a. Frequency of different HPV genotypes detected.
b. association of specific high-risk HPV genotypes with histologically confirmed precancerous (CIN2/3) and cancerous lesions.
3. Association Between HPV infection and cytological abnormalities:
a. Proportion of HPV-positive women with abnormal cytology results.
b. association between HPV genotype and cytological abnormalities such as ASCUS,LSIL and HSIL
|
12 Months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparison of Cervical Cancer Screening Methods & Diagnostic Accuracy:
a)Sensitivity, specificity, positive predictive value (PPV), and negative predictive value
(NPV) of different screening methods (VIA, HPV testing, Pap smear, Colposcopy).
b)Agreement between different screening modalities and histopathological findings.
2.Performance of Colposcopy in VIA & HPV-Based Screening Services:
a) Diagnostic accuracy of Colposcopy in detecting cervical precancerous/cancerous
lesions.
b) Agreement between Colposcopic findings and histopathological findings.
|
12 Months |
|
|
Target Sample Size
|
Total Sample Size="26400"
Sample Size from India="26400"
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)
|
01/05/2025 |
| 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="1"
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
|
Cervical cancer is a major public health problem worldwide, being the fourth most common cause of cancer and death among women. About one in every 70 women globally develops cervical cancer at some point in her life, with India accounting for a significant portion of the deaths from this disease. There are three main ways to screen for cervical cancer: Pap smear, HPV DNA testing, and visual inspection with acetic acid Early detection of HPV infection and precancerous lesions through regular screenings can significantly reduce the incidence of cervical cancer and improve treatment outcomes. By identifying risk factors associated with HPV infection and CIN, targeted preventive measures and interventions can be implemented more effectively. Overall, this study contributes to the global effort to combat cervical cancer by informing healthcare policies and resource allocation strategies based on evidence-based screening methods. This study aims to evaluate the effectiveness of cervical cancer screening methods by comparing the accuracy of different screening methods by analyzing the medical records of 26,400 women who underwent screenings between 2008 and 2023 at the Department of Preventive Oncology. These findings will provide valuable insights into the performance of each screening method, aiding healthcare providers in selecting the most effective approach, especially in resource-constrained settings.
|