| CTRI Number |
CTRI/2020/09/027641 [Registered on: 07/09/2020] Trial Registered Prospectively |
| Last Modified On: |
04/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The study of correlation between two pathological test in Ear,Nose, Throat diseas managment |
|
Scientific Title of Study
|
A study of Correlation between frozen section examination and histopathological examination of otorhinolaryngologiacal specimen for ENT managment |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nilam T Senta |
| Designation |
First year resident otorhinolaryngology |
| Affiliation |
Government medical college, Bhavnagar |
| Address |
Otorhinolaryngology Department ,Sir T hospital , GMC, Bhavnagar
Room no. 201 PG 3 hostel, Sir T Hospital, Bhavnagar
Bharuch
GUJARAT
364001
India |
| Phone |
7600053579 |
| Fax |
|
| Email |
npkucha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sushil G Jha |
| Designation |
Head of Department,otorhinolaryngology |
| Affiliation |
Government medical college, Bhavnagar |
| Address |
D 1,2 Himalaya Skyz flats,behind Himalaya mall,Bhavnagar 364001
Otorhinolaryngology department, Sir T Hospital, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9426909700 |
| Fax |
|
| Email |
sushilkgjhatanmay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nilam T Senta |
| Designation |
First year resident otorhinolaryngology |
| Affiliation |
Government medical college, Bhavnagar |
| Address |
Room no. 201 , PG 3 hostel ,Sir T hospital , GMC, Bhavnagar
Otorhinolaryngology department, Government medical college, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
7600053579 |
| Fax |
|
| Email |
npkucha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Otorhinolaryngology
Sir T Hospital ,Government medical college ,Bhavnagar |
|
|
Primary Sponsor
|
| Name |
Department of Otorhinolaryngology |
| Address |
Department of Otorhinolaryngology
Sir T Hospital ,Government medical college ,Bhavnagar |
| Type of Sponsor |
Government medical college |
|
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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 |
| Senta Nilam Thakarbhai |
Sir Takhtasinhji general hospital |
E.N.T department ,Sir T hospital , Bhavnagar
Bhavnagar
GUJARAT |
7600053579
npkucha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human ethics committee, Goverment medical college bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Lesion in ear, nose , throat, (1) ICD-10 Condition: C021||Malignant neoplasm of border of tongue, (2) ICD-10 Condition: C039||Malignant neoplasm of gum, unspecified, (3) ICD-10 Condition: C07||Malignant neoplasm of parotid gland, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject who give inform and written consent.
2. Subject who require removal of lesion from ear, nose, oral cavity ,nasopharynx,oropharynx, hypopharynx,larynx, face,neck including the entire atypical lesion.
3.subject with long standing ulcers, which are suspicious of malignancy from ear, nose, oral cavity , nasopharynx, oropharynx, hypopharynx, larynx, face , neck . |
|
| ExclusionCriteria |
| Details |
1.Subject who did not give inform and written consent.
2. Tissue specimen less than 0.2 cm in frozen section. |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Study helps in better prognosis of the patient, september,2020 |
Study helps in better prognosis of the pateint |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Study helps to reduce morbidity and mortality of the pateint. |
2 years. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
07/09/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A correlational study between frozen section and histopathological examination of otorhinolaryngological specimen for ENT managment , which compares the results of two test on single lesion. |