| CTRI Number |
CTRI/2018/01/011413 [Registered on: 18/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
17/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Visual Inspection after Application of Acetic Acid versus Pap smear in Cervical cancer screening |
|
Scientific Title of Study
|
A Study of the Effectiveness of Cervical Cytology versus Visual Inspection after Application of Acetic Acid in the Diagnosis of Precancerous Lesions of Cervix. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anchal Agarwal |
| Designation |
DNB Final year |
| Affiliation |
Tata Motors Hospital |
| Address |
Department of Obstetrics and Gynaecology, First floor, Tata Motors Hospital, Telco Colony, Jamshedpur.
Purbi Singhbhum
JHARKHAND
831004
India |
| Phone |
7488343489 |
| Fax |
|
| Email |
anchalagarwal2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Somenath Ghosh |
| Designation |
Consultant |
| Affiliation |
Tata Motors Hospital |
| Address |
Department of Obstetrics and Gynaecology,Tata Motors Hospital, Telco Colony, Jamshedpur.
Purbi Singhbhum
JHARKHAND
831004
India |
| Phone |
9031079040 |
| Fax |
|
| Email |
drsomenath1977@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anchal Agarwal |
| Designation |
DNB Final year |
| Affiliation |
Tata Motors Hospital |
| Address |
Department of Obstetrics and Gynaecology, First floor, Tata Motors Hospital, Telco Colony, Jamshedpur.
Purbi Singhbhum
JHARKHAND
831004
India |
| Phone |
7488343489 |
| Fax |
|
| Email |
anchalagarwal2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and Gynaecology, First Floor, Tata Motors Hospital,
Telco Colony, Jamshedpur. Jharkhand, India
Pin Code- 831004 |
|
|
Primary Sponsor
|
| Name |
Tata Motors Hospital Department of Obstetrics and Gynecology |
| Address |
Department of Obstetrics and Gynaecology, First floor, Tata Motors Hospital, Telco Colony, Jamshedpur, Jharkhand. Pin Code 831004 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Anchal Agarwal |
Tata Motors Hospital |
Department of Obstetrics and Gynaecology, First Floor, Tata Motors Hospital, Telco Colony, Jamshedpur. Pin code 831004
Purbi Singhbhum
JHARKHAND |
7488343489
anchalagarwal2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Motors Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Screening for Cervical Precancerous Lesions , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Women with or without cervical symptoms like -Abnormal Discharge per vaginum, post coital bleeding, postmenopausal bleeding, inter-menstrual bleeding, irrespective of the appearance of her cervix, willing to undergo cervical cytology test, visual inspection after application of acetic acid and colposcopy directed biopsy for screening for cervical precancerous lesions |
|
| ExclusionCriteria |
| Details |
Pregnant women or suspicion of pregnancy, women menstruating at the time of examination and women previously diagnosed or treated for precancerous or cancerous cervical
lesions.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensitivity, Specificity, Positive predictive value and Negative predictive value of Cervical Cytology and Visual Inspection after Application of Acetic Acid and their comparison |
Two years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cervical Cytology and Visual Inspection after Application of Acetic Acid taken together compared to one of these diagnostic modalities alone |
Two years |
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
Final Enrollment numbers achieved (Total)= "146"
Final Enrollment numbers achieved (India)="146" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/06/2015 |
| Date of Study Completion (India) |
09/05/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a cross sectional observational comparative single center study comparing visual inspection after application of acetic acid and cervical cytology by Pap smear using histopathology as gold standard ,over 2 years on 146 women aged 20 to 70 years with or without cervical symptoms willing for screening for cervical precancerous lesions. The primary outcome is the sensitivity, specificity, positive predictive value and negative predictive value of cervical cytology and visual inspection after application of acetic acid. |