CTRI Number |
CTRI/2021/03/032299 [Registered on: 25/03/2021] Trial Registered Prospectively |
Last Modified On: |
24/03/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
PROSPECTIVE OBSERVATIONAL STUDY |
Study Design |
Other |
Public Title of Study
|
Role of artificial intelligence in detecting cervical cancer |
Scientific Title of Study
|
Role of visual inspection with acetic acid-artificial intelligence using Easy Cervical Optimiser device in identification of cervical epithelial abnormalities |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Ayesha Siddiqua |
Designation |
Junior Resident(1st year),MS OBG |
Affiliation |
Kasturba Medical College, Manipal |
Address |
Department Of OBG,Kasturba MEdical College,Manipal
Udupi KARNATAKA 576104 India |
Phone |
8790509701 |
Fax |
|
Email |
ayesha.siddiqua@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
Name |
DRShyamala G |
Designation |
Professor and Head of unit |
Affiliation |
Kasturba Medical College, Manipal |
Address |
Professsor and head of unit.obg3,Department of OBG,Kasturba medical college ,Manipal
Udupi KARNATAKA 576104 India |
Phone |
8790509701 |
Fax |
|
Email |
shyamala.g@manipal.edu |
|
Details of Contact Person Public Query
|
Name |
DRShyamala G |
Designation |
Professor and Head of unit |
Affiliation |
Kasturba Medical College, Manipal |
Address |
Professsor and head of unit.obg3,Department of OBG,Kasturba medical college ,Manipal
Udupi KARNATAKA 576104 India |
Phone |
8790509701 |
Fax |
|
Email |
shyamala.g@manipal.edu |
|
Source of Monetary or Material Support
|
Applying for PG thesis grant
KASTURBA HOSPITAL
KASTURBA MEDICAL COLLEGE,MANIPAL |
|
Primary Sponsor
|
Name |
Ayesha Siddiqua |
Address |
Department of OBG,Kasturba medical college,Manipal |
Type of Sponsor |
Other [Self] |
|
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 |
Ayesha Siddiqua |
Kasturba Hospital,Department of OBG,KMC Manipal |
Department of OBG,Kasturba Medical College,Manipal Udupi KARNATAKA |
8790509701
ayesha.siddiqua@learner.manipal.edu |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee,KMC MANIPAL |
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
|
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Female |
Details |
1.Women between 30- 65 years who are
Subjected to routine cervical screening
2.Includes those scheduled for colposcopic evaluation for indications-
-Positive Pap test (ASCUS/ASC-H/LSIL/HSIL/Invasive -carcinoma (Bethesda classification)
-HR-HPV positive
-Clinically suspicious cervix
|
|
ExclusionCriteria |
Details |
1.Obvious growth on cervix (Ca cervix)
2.Unmarried woman
3.Pregnant/ postpartum
4.Menstruating on the day of the visit
5.Genital prolapse grade 2 and beyond
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1.Comparison of VIA –AI using ECO device with colposcopy diagnosis in identification of cervical epithelial abnormalities for screen positive women
2.Comparison of VIA –AI using ECO device with histopathology reports
3.Comparison of VIA –AI using ECO device with screen test (Pap smear/ HPV) results
|
4 WEEKS |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.Analysis of sensitivity,specifivity of VIA-AI using ECO device with standard screening procedures of carcinoma cervix |
1 YEAR |
|
Target Sample Size
|
Total Sample Size="326" Sample Size from India="326"
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)
|
31/03/2021 |
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
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Cancer of the uterine
cervix is the second most common cancer among Indian women, and accounts for
25% of global mortality due to cervical cancer. This is due to higher
incidence, and late diagnosis of cervical cancer. Some of the commonly used screening tests
for early detection of cervical cancer are Pap smear, HPV-DNA and visual
inspection with acetic acid (VIA). Pap smear is the most commonly used method
for cervical cancer screening. It depends on availability of laboratory
facility and medical experts for smear preparation and analysis, which is
lacking in developing countries. VIA evaluates the cervix for acetowhite (AW)
regions which are formed when precancerous lesions combine with acetic acid. It
does not depend on well-established laboratory facility and hence is a
cost-effective test. It is a simple test as it is based on visual examination
of the cervix after the application of acetic acid. Thus, it is well suited for
screening in developing countries.VIA is a suitable
test for low-resource settings as far as the simplicity of the test is
considered, it requires skilled personnel for the evaluation of the acetowhite
regions. Depending on the skills of the ones who perform the test, accuracy of
VIA varies widely, with significantly higher sensitivity and specificity when
observed by physicians than by nurses . An automated system for cervix image analysis might be able to
overcome this problem, providing objective and repeatable evaluations. Advances
in digital imaging and image processing have facilitated the acquisition of
good-quality cervix images during the VIA procedure. At present, digital images
of the cervix are acquired using a digital camera or a digital colposcope.
Acquisition of cervix images using the digital camera and subsequent analysis
of the images by skilled personnel is called cervicography. Since images acquired
can be stored and sent over the Internet, it enables remote diagnosis. Digital
colposcopy facilitates the acquisition of high-magnification cervix images.
However, it is expensive and hence is not feasible for screening in
resource-poor settings. An android device with an inbuilt app to acquire images
and provide instant results would be an obvious choice in resource-poor
settings. Our overall goal is to analyse sensitivity, specificity, positive predictive value, negative predictive
value, accuracy and ROC of Easy Cervical
Optimiser(EC0) device which facilitates
acquisition and processing of images with an inbuilt image processing
algorithm. Such a system would be useful to augment the capability of a lay
health worker performing the VIA examination to offer instant decision whether
the individual requires further evaluation or not. |