| CTRI Number |
CTRI/2022/02/040066 [Registered on: 07/02/2022] Trial Registered Prospectively |
| Last Modified On: |
05/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical testing of the smartphone based device for early cervical cancer diagnosis |
|
Scientific Title of Study
|
Clinical testing of smartphone based upgraded form of existing fluorescence spectroscopic device for early cervical cancer diagnosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shikha Ahirwar |
| Designation |
Director |
| Affiliation |
PhotoSpIMeDx Private Limited |
| Address |
SL-111, ACADEMIC AREA, IIT KANPUR
Kanpur Nagar
UTTAR PRADESH
208016
India |
| Phone |
9651605272 |
| Fax |
|
| Email |
aahirwar36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Pandey |
| Designation |
Professor |
| Affiliation |
GSVM Medical College, Kanpur |
| Address |
Department of obstetrics & gynaecology, Division: O&G
GSVM Medical College, Kanpur, U.P.
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9415050322 |
| Fax |
|
| Email |
dr.kiranpandey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shikha Ahirwar |
| Designation |
Cofounder & Director |
| Affiliation |
PhotoSpIMeDx Pvt Ltd |
| Address |
NRA140, RA TOWER, IIT KANPUR
Kanpur Nagar
UTTAR PRADESH
208016
India |
| Phone |
9651605272 |
| Fax |
|
| Email |
aahirwar36@gmail.com |
|
|
Source of Monetary or Material Support
|
| PhotoSpIMeDx Private Limited |
|
|
Primary Sponsor
|
| Name |
PhotoSpIMeDx Private Limited |
| Address |
SL-111, ACADEMIC AREA, IIT KANPUR, U.P., 208016 |
| Type of Sponsor |
Other [PRIVATE LIMITED] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Kiran Pandey |
GSVM Medical College Kanpur, Swaroop Nagar, Kanpur Nagar, Kanpur, U.P., 208002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kiran Pandey |
GSVM MEDICAL COLLEGE |
Professor, Department of Gynecology & Obstetrics, GSVM Medical College Kanpur
Kanpur Nagar
UTTAR PRADESH |
9415050322
dr.kiranpandey@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GSVM MEDICAL COLLEGE KANPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients who dont have signs and symptoms of Cervical cancer |
| Patients |
(1) ICD-10 Condition: B977||Papillomavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cervical cancer detection device |
This device is a smartphone based fluorescence spectroscopic device which will be used for detecting early cervical cancer detection. |
| Intervention |
Colposcopy |
Colposcopy is a procedure to closely examine your cervix, vagina and vulva for signs of disease. During colposcopy, your doctor uses a special instrument called a colposcope. |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Pap smear test |
Pap test is a screening procedure for cervical cancer. It tests for the presence of precancerous or cancerous cells on your cervix. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Women patients who visit the OPD and have symptoms or not of cervical cancer. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome of study is the fluorescence signal captured from the patients that provide the biochemical changes happening inside the tissues during cancer progression. The fluorescence signal captures the changes of certain biomarkers which are present intrinsically such as FAD, Porphyrin, NADH etc. There concentration changes as as the cancer progresses inside the human. |
The outcome of the study will be assessed after every 4 weeks from the date of trials start. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
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)
|
07/02/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Cervical cancer is one of the leading causes of deaths for women in India with an estimated 97,000 new cases and 60,000 deaths reported according to a report released by WHO in 2018. For cancers, early diagnosis is critical as it offers the patient an opportunity for successful curative treatment. In India, the crux of the problem lies in the lack of quality diagnostics, which could be affordable to all sectors of society and accessible to the remotest part of the country. Conventional techniques for cervical cancer detection are time-consuming, expensive, invasive by nature, limited by specificity and sensitivity and require experienced professionals for their operation. Among them histopathology with biopsy is the gold standard. Optical techniques, on the other hand, offer minimally invasive, fast and real time analysis criteria for diagnosis. This study focuses on the early detection of cervical cancer on the basis of spectroscopic differences present in different grades, CINI, CINII and CINIII, in their intrinsic fluorescence response. The device for cervical precancer diagnosis has been upgraded to a smartphone-based platform. Measurements will be done on patients with cervical pre-cancers of various grades. The selection will be done by the pathologist and gynaecologist involved in the project. The data recorded from the patient will be stored in the cloud storage and it will be used to analyze the data for classifying the grades of the cancer. The examined patient’s pap smear and colposcopy reports will also be compared for classification purpose. |