| CTRI Number |
CTRI/2024/02/063074 [Registered on: 23/02/2024] Trial Registered Prospectively |
| Last Modified On: |
22/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Multiple sectioning of lymph node to look for micro metastasis and extension of tumor beyond lymph node capsule |
|
Scientific Title of Study
|
step serial sectioning of lymph node in oral squamous cell carcinoma for micrometastasis and extranodal extension:A cross sectional study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahima jaiswal |
| Designation |
Junior resident |
| Affiliation |
Rohilkhand Medical college and hospital |
| Address |
Room no 1160 Department of pathology Rohilkhand Medical college and hospital, Pilibhit bypass road, Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7523920427 |
| Fax |
|
| Email |
jaiswalmahima48@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mithila Bisht |
| Designation |
Professor |
| Affiliation |
Rohilkhand Medical college and hospital |
| Address |
Department of Pathology, Room no. 1164, Rohilkhand Medical college and hospital, Pilibhit bypass road, Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7906080213 |
| Fax |
|
| Email |
dr.mithila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahima jaiswal |
| Designation |
Junior resident |
| Affiliation |
Rohilkhand Medical college and hospital |
| Address |
Department of Pathology, Room no 1162,Rohilkhand Medical college and hospital, Pilibhit bypass road, Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7523920427 |
| Fax |
|
| Email |
jaiswalmahima48@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand medical college and hospital, Pilibhit bypass road, Bareilly |
|
|
Primary Sponsor
|
| Name |
Mahima jaiswal |
| Address |
Rohilkhand Medical College Hospital |
| Type of Sponsor |
Other [Self] |
|
|
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 Mahima Jaiswal |
Rohilkhand medical college and hospital |
Histo pathology lab, Department of Pathology,Rohilkhand medical college and hospital ,Pilibhit bypass road
Bareilly
UTTAR PRADESH |
7523920427
jaiswalmahima48@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RMCH,Bareilly |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, (2) ICD-10 Condition: C068||Malignant neoplasm of overlappingsites of other and unspecified parts of mouth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All histopathologically diagnosed cases of oral squamous cell carcinoma undergoing radical neck dissection and showing:
Node negative(NO) on pN staging
pN stage N1-N3 with ENE negative status. |
|
| ExclusionCriteria |
| Details |
• Cases showing both nodal positivity and ENE positivity on H&E staining.
• Cases of oral squamous cell carcinoma who have undergone pre-operative chemotherapy and radiotherapy.
• Cases with recurrence of disease.
• Cases with any concurrent malignancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To classify oral squamous cell carcinomas based on pathological tumor(pT) and nodal
stage(pN)
To determine the percentage increased nodal positivity in the node negative (NO) cases of radical neck dissection of oral squamous cell carcinoma on applying step serial
sectioning.
To calculate the percentage of increased ENE positive status in cases of ENE negative and nodal positive squamous cell carcinoma with use of step serial sectioning. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To classify oral squamous cell carcinomas based on pathological tumor(pT) & nodal stage(pN)
To determine the percentage increased nodal positivity in the node negative (NO) cases of radical neck dissection of oral squamous cell carcinoma on applying step serial
sectioning.
• To calculate the percentage of increased ENE positive status in cases of ENE negative & nodal positive squamous cell carcinoma with use of step serial sectioning. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
02/03/2024 |
| 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="1"
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
|
- The study will be conducted in the Department of Pathology, Rohilkhand Medical College and Hospital, Bareilly after taking approval from Institutional Ethics Committee.
- The recieved specimen will be subjected to gross and microscopic examination as per standard protocol.
- The largest lymph node will be identified and measured.
- Lymph node <5mm will be submitted as whole and those with size >5mm will be bisected
into two halves and submitted in one cassette. - Paraffin embedded tissues (4-5 micron) will be cut and stained by Hematoxylin and Eosin
stain. - After staining slide will be subjected to microscopic examination and decision for step serial sectioning will be taken as under:-
- In the microscopy cases with largest lymph node identified as positive but ENE negative will be subjected to step serial sectioning to identify ENE.
- Those lymph node which are identified as node negative on routine H&E staining ie NO will be further taken up for step serial sectioning to look for micrometastasis and ENE involvement by two independent pathologist.
- Serial microsections each measuring 4-5 micro meter will be retained every 100 micrometer till the tissue is completely exhausted.
|