| CTRI Number |
CTRI/2024/08/072011 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to relate depth of invasion with lymph node metastasis in laryngeal and hypopharyngeal cancer. |
|
Scientific Title of Study
|
Correlation of depth of invasion with lymph node metastasis in laryngeal and hypopharyngeal carcinoma. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chirom Amit Singh |
| Designation |
Professor |
| Affiliation |
ALL INDIA INSTITUE OF MEDICAL SCIENCES |
| Address |
Department of Otorhinolaryngology, AIIMS New Delhi, Room no 4075
AIIMS, NEW DELHI
South
DELHI
110049
India |
| Phone |
9868397478 |
| Fax |
|
| Email |
amitchirom@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chirom Amit Singh |
| Designation |
Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Otorhinolaryngology, AIIMS New Delhi, Room no 4075
South
DELHI
110049
India |
| Phone |
9868397478 |
| Fax |
|
| Email |
amitchirom@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chirom Amit Singh |
| Designation |
Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICALSCIENCES |
| Address |
Department of Otorhinolaryngology, AIIMS New Delhi, Room no 4053A
South
DELHI
110049
India |
| Phone |
9868397478 |
| Fax |
|
| Email |
amitchirom@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS, New Delhi |
| Address |
AIIMS, Ansari Nagar, New Delhi - 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Lovely Kumari |
All India Institute of Medical Sciences |
Department of Otorhinolaryngology, D4 ward, Ansari Nagar, New Delhi
South
DELHI
South
DELHI |
8130140587
rrdlovely264@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C139||Malignant neoplasm of hypopharynx,unspecified, |
|
|
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. Biopsy proven laryngeal and hypopharyngeal carcinoma
2. Patients planned for surgery
3. Clinical data and demographic profile available
4. Informed and written consent of the patient
|
|
| ExclusionCriteria |
| Details |
1. Previously received chemo and/or radiotherapy
2. Recurrent primary tumour
3. Patient unwilling to participate in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To see
1. Depth of invasion of tumour in HPE
2. Lymph node metastasis in HPE
3. Maximum Dimension of tumour in radiological imaging |
its cross sectional study, no follow up required.
outcome will be assessed after histopathology reports come, which usually takes 2-3 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To see
1. Tumour volume estimation on HPE |
will be assessed at baseline alongwith other histopath reports |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/03/2025 |
| 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="1"
Months="9"
Days="8" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
My study titled "CORRELATION OF DEPTH OF INVASION WITH LYMPH NODE METASTASIS IN LARYNGEAL AND HYPOPHARYNGEAL CARCINOMA "aims at finding pre-operatively maximum dimension of tumour in radiology(CECT/MRI), post-operatively DOI on HPE and correlating it to lymph node metastasis on post op HPE along with tumour volume estimation in post operative specimen. |