CTRI

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CTRI Number

CTRI/2025/02/080571 [Registered on: 14/02/2025] Trial Registered Prospectively

Last Modified On:

10/02/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Single Arm Study

Public Title of Study

Study Involving Identification of Cerebrospinal Fluid Biomarker and Developing a Bedside Testing Device for rapid and accurate Diagnosis Cerebrospinal Fluid leak in Suspected Individuals

Scientific Title of Study

Identification and Validation of Cerebrospinal fluid (CSF) Biomarker in Bodily fluids and Development of Point of Care Device for Diagnosing CSF leak

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Saraswathi N
Designation	PhD Scholar
Affiliation	Kasturba Medical College, Manipal
Address	Department of biochemistry, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India-576104 Udupi KARNATAKA 576104 India
Phone	7829842991
Fax
Email	sarsu_nawada@yahoo.in

Details of Contact Person
Scientific Query

Name	Dr Revathi P Shenoy
Designation	Associate Professor and Guide
Affiliation	Kasturba Medical College, Manipal
Address	Department of biochemistry, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India-576104 Udupi KARNATAKA 576104 India
Phone	9449367734
Fax
Email	revathi.shenoy@manipal.edu

Details of Contact Person
Public Query

Name	DrSuresh Pillai
Designation	Professor and Head and Co-investigator
Affiliation	Kasturba Medical College, Manipal
Address	Department of Otorhinolaryngology-Head and Neck surgery, Kasturba Medical College, Manipal, Karnataka Udupi KARNATAKA 576104 India
Phone	9901728977
Fax
Email	suresh.pillai@manipal.edu

Source of Monetary or Material Support

Kasturba Medical college, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India 576104

Primary Sponsor

Name	Saraswathi N
Address	Department of Biochemistry, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India - 576104
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 3
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Kailesh Pujary	Kasturba Medical College	4th floor Room number 10 Department of Otorhinolaryngology Kasturba Medical college, Manipal, Karnataka, India 576104 Udupi KARNATAKA	9845144015 kailesh.pujary@manipal.edu
Dr Revathi P Shenoy	Kasturba Medical College	Clinical Lab and Research lab, 1st floor, Department of Biochemistry, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India 576104 Udupi KARNATAKA	9449367734 revathi.shenoy@manipal.edu
Dr Suresh Pillai	Kasturba Medical College	4th floor Department of Otorhinolaryngology Kasturba Medical College, Manipal, Karnataka, India 576104 Udupi KARNATAKA	9901728977 suresh.pillai@manipal.edu

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Kasturba Medical College and Kasturba Hospital Institutional Ethics Comittee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: G960\|\|Cerebrospinal fluid leak,

Intervention / Comparator Agent

Type	Name	Details
Intervention	NIL	NIL
Comparator Agent	NIL	NIL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	1. Adult patients above the age of 18 years 2. Patients suspicious of CSF leak with clinical symptoms such as orthostatic headache or recurrent rhinorrhea or otorrhea after trauma or endonasal surgery or spontaneously.

ExclusionCriteria

Details

1. Pregnant women.
2. Patient with a history of neurological disorders.
3. Patients undergoing treatment for neurological disorders.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To measure specificity, sensitivity and diagnostic accuracy of identified biomarker and developed assay method in diagnosing CSF leak	3 years 6 months

Secondary Outcome

Outcome	TimePoints
To identify more sensitive and specific biomarker for CSF leak diagnosis	1 year
Evaluation of clinical performance of the POC device developed for diagnosing CSF leak	18 months

Target Sample Size

Total Sample Size="255"
Sample Size from India="255"
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)

10/03/2025

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="6"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

This prospective cross-sectional observational study aims to develop a standardized, accurate, and rapid clinically validated point-of-care testing (POCT) method for diagnosing cerebrospinal fluid (CSF) leaks in body fluids. The goal is to improve diagnostic accuracy and reduce the time required for CSF leak diagnosis, which currently relies primarily on radiological examination. Although radiological examinations are precise and accurate, they require skilled operators, high-end equipment, and may pose risks and burdens on patients. Therefore, developing non-invasive laboratory-based methods for diagnosing CSF leaks with a standardized assay through POCT will reduce risks and burdens for both patients and investigators.

This single-centered study will validate biomarkers and evaluate the performance of the developed POCT by collecting clinical samples from 255 patients and comparing the results with a reference standard used for diagnosis. The primary outcome is to measure the specificity, sensitivity, and diagnostic accuracy of the identified biomarker and developed assay methods over three years. The secondary outcome is to identify a more sensitive and specific biomarker at the one-year mark and evaluate the diagnostic performance of the developed POCT in a clinical setting over 18 months.