| CTRI Number |
CTRI/2020/08/027398 [Registered on: 26/08/2020] Trial Registered Prospectively |
| Last Modified On: |
25/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Screening of Renal Cancer |
|
Scientific Title of Study
|
Optical Spectroscopy Combined with HPLC-LIF to Differentiate Benign and Malignant Renal Tissues. |
| 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
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
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
Udupi
KARNATAKA
576104
India |
| Phone |
9880092297 |
| Fax |
|
| Email |
santhosh.cls@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| 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 Santhosh Chidangil |
Kasturba Medical College, MAHE, Manipal |
Manipal
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA |
9880092297
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: C649||Malignant neoplasm of unspecifiedkidney, except renal pelvis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
All above 18 years of age and having malignant or benign type of kidney cancer (like clear cell renal cell carcinoma, urothelial carcinoma, chromophobe renal cell carcinoma, oncocytoma,angiomyolipoma and cystic renal cell carcinoma) are included. |
|
| ExclusionCriteria |
| Details |
All male and female below age 18 are excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The fluorescence spectroscopy can be very useful to explore the mechanism involved during the progression of renal cancer. Along with multivariate data analysis the fluorescence spectra can give useful information for the objective diagnosis of tissue samples. The Raman spectrum and the HPLC-LIF protein profile can give complementary information of the tissue along with the LIF based diagnosis. |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It can be extended to different type of cancer such as breast 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)
|
31/08/2020 |
| 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
|
Not yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The spectroscopic techniques are emerging as an effective tool for detection of cancers in an effective way.This technique has a potential to be used as an alternative of biopsy which is called as optical biopsy.This single center observational study mainly aims the development of a compact device which is capable of acting like an optical biopsy device.Along with that the HPLC-LIF system will be giving the protein profiles of body fluids which in turn gives the early signatures of renal cancer. |