| CTRI Number |
CTRI/2024/04/065902 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
09/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To learn sinonasal masses by there clinical and pathological features |
|
Scientific Title of Study
|
Clinico-pathological profile of sinonasal masses in rural population of central India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Patil Vaibhavi Vivek |
| Designation |
junior resident in department of ent |
| Affiliation |
Datta Meghe institute of higher education and research |
| Address |
department of ENT , c block .
Acharya Vinob Bhave eural hospital
sawangi
(meghe) wardha
Wardha
MAHARASHTRA
442004
India |
| Phone |
9404215880 |
| Fax |
|
| Email |
vabi0312@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Patil Vaibhavi Vivek |
| Designation |
junior resident in department of ent |
| Affiliation |
Datta Meghe institute of higher education and research |
| Address |
department of ENT , c block .
Acharya Vinob Bhave eural hospital
sawangi
(meghe) wardha
Wardha
MAHARASHTRA
442004
India |
| Phone |
9404215880 |
| Fax |
|
| Email |
vabi0312@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Patil Vaibhavi Vivek |
| Designation |
junior resident in department of ent |
| Affiliation |
Datta Meghe institute of higher education and research |
| Address |
department of ENT , c block .
Acharya Vinob Bhave eural hospital
sawangi
(meghe) wardha
Wardha
MAHARASHTRA
442004
India |
| Phone |
9404215880 |
| Fax |
|
| Email |
vabi0312@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of higher eduaction and research sawangi (meghe ) wardha |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of higher education and research |
| Address |
Sawangi (Meghe ) Wardha |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Vaibhavi Patil |
jawaharlal nehru medical college |
DMIHER
Wardha
MAHARASHTRA |
9404215880
vabi0312@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta meghe institute of higher education and research (deemed to be university)INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C300||Malignant neoplasm of nasal cavity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All sino nasal masses inn paranasal sinuses , nasal cavity and sino nasal area in 5 yr -80 yr age group |
|
| ExclusionCriteria |
| Details |
congenital masses
nasopharyngeal masses
patient with extra - nasal masses impingig nasal cavity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| In this study, in the age group of 5 to 80 years of age , the various sino-nasal masses will be evaluated ,examined and statistically analyzed on the basis of the literature available , and a clinicopathological profile can be initiated especially involving the rural population of central India. |
In this study, in the age group of 5 to 80 years of age , the various sino-nasal masses will be evaluated ,examined and statistically analyzed on the basis of the literature available , and a clinicopathological profile can be initiated especially involving the rural population of central India. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
25/04/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Nasal cavity and paranasal sinuses are anatomically and physiologically related very intimately. The sinus and nasal cavity mucosa have anatomical continuity and also share the same functions. By virtue of close anatomical relationship, some diseases may affect both nose and the paranasal sinuses. These include allergic, inflammatory, granulomatous, benign and malignant disorders. Some of them can present as Sino-nasal lesions while some can affect nasal cavity and paranasal sinuses in isolation. The anatomical and structural variation in the lateral nasal wall which is also the common parting wall between nasal cavity and maxillo-ethmoidal complex can contribute to spread extend and manifestation of those lesions. |