| CTRI Number |
CTRI/2019/02/017718 [Registered on: 19/02/2019] Trial Registered Prospectively |
| Last Modified On: |
13/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Screening of Cervical Cancer |
|
Scientific Title of Study
|
Development and Demonstration of Screening device for early detection of Cervical Cancer using Laser Spectroscopy 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 Santhosh Chidangil |
| Designation |
Professor and HOD |
| Affiliation |
Department of Atomic and Molecular Physics, MAHE, Manipal |
| Address |
Department of Atomic and Molecular Physics, LG-01, AB-5, MIT, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9880092297 |
| Fax |
|
| Email |
santhosh.cls@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santhosh Chidangil |
| Designation |
Professor and HOD |
| Affiliation |
Department of Atomic and Molecular Physics, MAHE, Manipal |
| Address |
Department of Atomic and Molecular Physics, LG-01, AB-5, MIT, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9880092297 |
| Fax |
|
| Email |
santhosh.cls@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santhosh Chidangil |
| Designation |
Professor and HOD |
| Affiliation |
Department of Atomic and Molecular Physics, MAHE, Manipal |
| Address |
Department of Atomic and Molecular Physics, LG-01, AB-5, MIT, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9880092297 |
| Fax |
|
| Email |
santhosh.cls@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Vision Group on Science and Technology, Govt of Karnataka,
7th Floor, 4th Gate, M.S. Building, Dr. Ambedkar Veedhi, Bengaluru, Karnataka 560001 |
|
|
Primary Sponsor
|
| Name |
Vision Group on Science and Technology Govt of Karnataka |
| Address |
7th Floor, 4th Gate, M.S. Building, Dr. Ambedkar Veedhi, Bengaluru, Karnataka 560001 |
| Type of Sponsor |
Government funding agency |
|
|
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 Santhosh Chidangil |
Kasturba Medical College, MAHE, Manipal |
Department of Atomic and Molecular Physics, LG-01, AB-5, MIT, Manipal Academy of Higher Education, Manipal- 576104
Udupi
KARNATAKA |
08202925071
santhosh.cls@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital,Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Only female of this age group |
|
| ExclusionCriteria |
| Details |
Women below 18 years and above 70, and all men |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome might improve the diagnosis of cervical cancer at early stage and might help in treatment in future |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It can be extended to different type of cancer such as breast and ovary cancer |
3 years |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
01/03/2019 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Non yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The spectroscopy based techniques are coming up as promising techniques for the early detection and screening of different types of cancers (e.g. cervical, breast etc). Along with the multivariate data analysis, the fluorescence spectra can give very useful information about the onset of cervical cancer. The HPLC-LIF protein profile technique has the capability to detect protein signatures for cervical cancer in different clinical samples. An improved version of LIF setup for the cervical cancer screening and HPLC-LIF system for the detection of cancer markers in body fluids and cellular samples will be highly beneficial to the society to bring down the cervical cancer mortality. The study is a single center observational study. |