| CTRI Number |
CTRI/2014/02/004424 [Registered on: 20/02/2014] Trial Registered Retrospectively |
| Last Modified On: |
19/02/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Diagnostic
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial for early detection of cervical cancer using optical techniques |
|
Scientific Title of Study
|
Non-invasive detection of cervical malignancies using diffuse reflectance imaging and fluorescence/reflectance point
monitoring techniques
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suchetha S |
| Designation |
Associate Professor, |
| Affiliation |
Regional Cancer Centre |
| Address |
Division of Surgical Oncology, Regional Cancer Centre (RCC), Thiruvananthapuram–
Thiruvananthapuram
KERALA
695011
India |
| Phone |
04712522418 |
| Fax |
|
| Email |
suchethajyothish@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Subhash |
| Designation |
Chief Scientist |
| Affiliation |
Vinvish Technologies |
| Address |
Vinvish Technologies Ltd, C-16 Thejaswini Building, Technopark, Trivandrum
Thiruvananthapuram
KERALA
695581
India |
| Phone |
9400497015 |
| Fax |
|
| Email |
subhashnarayanan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Subhash |
| Designation |
Chief Scientist |
| Affiliation |
Vinvish Technologies |
| Address |
Vinvish Technologies Ltd, C-16 Thejaswini Building, Technopark, Trivandrum
Thiruvananthapuram
KERALA
695581
India |
| Phone |
9400497015 |
| Fax |
|
| Email |
subhashnarayanan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional Cancer Centre,Centre for Earth Science Studies |
|
|
Primary Sponsor
|
| Name |
Centre for Earth Science Studies |
| Address |
Akkulam,Thurivickal P O,Thiruvananthapuram-695031 |
| Type of Sponsor |
Research institution |
|
|
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 Suchetha S |
Regional Cancer Centre |
Division of Surgical Oncology
Medical College PO
Trivandrum 695011
Thiruvananthapuram
KERALA |
4712522418
suchethajyothish@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Regional Cancer Centre, Trivandrum |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with suspected cervical cancer/ precancerous lesions , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cervical cancer detection |
Diffuse reflectance imaging and fluorescence and diffuse reflectance point monitoring technique is used |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Patients with positive pap smear reports
Patients referred for colposcopic examination
Patients with any kind of clinically suspecting lesions in the uterine cervix
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients with transmittable diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification of the malignant site for optimal biopsy and histology; and Reduction of false negatives |
First arrival at OP clinic |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced trauma, morbidity; and Real-time, Noninvasive diagnosis |
At the first visit to Clinic |
|
|
Target Sample Size
|
Total Sample Size="43"
Sample Size from India="43"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
14/02/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study focuses on the noninvasive
detection of cervical pre-cancer/cancer using a spectroscopic point monitoring and
imaging systems and to develop an algorithm for grading the entire lesion based
on diffuse reflectance (DR) image ratios and cross validation by point
monitoring of tissue fluorescence, reflectance and pathology. Spectral variations in the cervix are studied using a fiber-optic point
monitoring device and based on the recorded spectral variation biopsy will be
collected from the measured cervical lesion for pathological correlation. DR image ratio and spectral data are analysed using multivariate
analytical methods and diagnostic accuracies will be calculated by comparing
the optical biopsy diagnosis with tissue biopsy (gold standard). As these
techniques are comparatively low cost, reliable, non-invasive and real time, it
will have a significant impact on health care in the future. |