| CTRI Number |
CTRI/2017/07/009005 [Registered on: 10/07/2017] Trial Registered Prospectively |
| Last Modified On: |
07/07/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Inspection Device For Cervical Cancer Screening |
|
Scientific Title of Study
|
GynaeCam - Inspection Device For Cervical Cancer Screening - A pilot study at Chennai. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Santosh Noronha |
| Designation |
Assistant Professor |
| Affiliation |
IIT Bombay |
| Address |
125B, Ground Floor,
Chemical Engineering Department,
IIT Bombay, Powai.
Mumbai - 400076
Maharashtra.
Mumbai
MAHARASHTRA
400 076
India |
| Phone |
02225767238 |
| Fax |
|
| Email |
noronha@iitb.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Santosh Noronha |
| Designation |
Assistant Professor |
| Affiliation |
IIT Bombay |
| Address |
125B, Ground Floor,
Chemical Engineering Department,
IIT Bombay, Powai.
Mumbai - 400076
Mumbai
MAHARASHTRA
400 076
India |
| Phone |
02225767238 |
| Fax |
|
| Email |
noronha@iitb.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
MsSripriya |
| Designation |
Vice president |
| Affiliation |
Agada Hospital |
| Address |
Consultation room no. 03
Basement
Agada Hospital
No.8,Dr.Nair Road,
T.Nagar
Channai - 600017
Chennai
TAMIL NADU
600117
India |
| Phone |
9840640571 |
| Fax |
|
| Email |
kidambipriya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chemical Engineering Department
125B, Ground Floor,
IIT Bombay, Powai.
Mumbai - 400076 |
|
|
Primary Sponsor
|
| Name |
IIT Bombay |
| Address |
IIT Bombay, Powai, Mumbai |
| Type of Sponsor |
Other [Internal Grant] |
|
|
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 |
| Mohan Thanikachalam |
Agada Hospital |
Room no.01
Second floor,
No.8 ,Dr.Nair Road,
T.Nagar
Channai - 600017
Chennai
TAMIL NADU |
04428152604
drmohan@agadahealthcare.net |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IITB-IEC |
Approved |
| IRB,Agada Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Precancerous/Cancerous lesions of the cervix. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gyneacam |
Screening device for early detection of pre-cancerous lesion.
The trial period 1 year. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Female |
| Details |
Women with an intact uterus, ever married, Women patients who visit the hospital for PAP Smear will also be enrolled, with prior consent. |
|
| ExclusionCriteria |
| Details |
Women who are pregnant /undergone hysterectomy/ treated for pre-cancers or cancers in the past / menstruating 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 |
| Concordance between Gyneacam and Pap smear results. |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of images |
1 year |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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)
|
20/07/2017 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Cervical cancer screening aids in detecting cancer prior to symptom manifestation in high risk women. It is carried out to identify and treat the cancer at the pre-cancerous stages eventually reducing the incidence and mortality of cervical cancer1 . Of the many screening procedures, cytology (Pap smear) is most commonly used. However, it is not feasible to perform cytology tests in remote locations in developing countries due to lack of infrastructure and trained manpower. The alternative procedures that could be employed in low resource settings are naked eye inspection after application of 3 – 5 % acetic acid (VIA), VIA using magnification devices (VIAM) and visual inspection after the application of Lugol’s iodine (VILI). VIA test is a suitable alternative to Pap smear, but it has higher sensitivity and lower specificity than Pap smear2,5 resulting in unnecessary treatment and diagnostic procedures. The problem of lower specificity in VIA is addressed by the use of a colposcope. This additional step made the procedure expensive, time consuming and warranted the need for Gynaecologist. As an alternative, magnifying devices to aid VIA procedure were developed specifically for low resource settings. The use of Magnivisualizer is proposed as a triage to select women or dispense with colposcopy entirely6,7. Studies with the comparative performance of Magnivisualizer for VIAM and colposcope have found that it can be safely and accurately used in place of colposcopy without loss of efficacy of screening where colposcopy is not available for early diagnosis of precancerous and cancerous lesions of the cervix . |