| CTRI Number |
CTRI/2024/09/074392 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Prospective observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To compare the efficacy of different tests used for high risk Human Papilloma Virus detection in cases of Squamous cell carcinoma that have spread to neck lymph nodes |
|
Scientific Title of Study
|
Comparative analysis of qPCR, mRNA ISH and p16 IHC for detection of high risk HPV on fine needle aspirates and core needle biopsies in patients with metastatic squamous cell carcinoma in cervical lymph nodes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AIIMSA1765/25.07.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anju K T |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Otorhinolaryngology and Head and Neck Surgery
Room No 4057
First floor Academic Block
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9497181833 |
| Fax |
|
| Email |
kaniyanthazath123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anju K T |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Otorhinolaryngology and Head and Neck Surgery
Room No 4057
First floor Academic Block
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9497181833 |
| Fax |
|
| Email |
kaniyanthazath123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Chirom Amit Singh |
| Designation |
Professor, Department of Otorhinolaryngology and Head and Neck Surgery, AIIMS Delhi |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Otorhinolaryngology and Head and Neck Surgery
Room No 4057
First floor Academic Block
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9999501928 |
| Fax |
|
| Email |
amitchirom@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences New Delhi, 110029 |
|
|
Primary Sponsor
|
| Name |
Dr Anju K T |
| Address |
Department of Otorhinolaryngology and Head and Neck Surgery
Room No 4057
First floor Academic block
AIIMS New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anju K T |
All India Institute of Medical Sciences New Delhi |
Department of Otorhinolaryngology and Head and Neck Surgery
Room No 4057
4th floor, Academic block
All India Institute of Medical Sciences New Delhi, 110029
South
DELHI |
9497181833
kaniyanthazath123@gmail.com |
| Dr Anju K T |
National Cancer Institute |
Department of Head and Neck Surgery
Room No 10, Ground floor
Academic block
National Cancer Institute
NCI - AIIMS
Badsa
Jhajjar
Haryana
124105
Jhajjar
HARYANA |
9497181833
kaniyanthazath123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research, AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C108||Malignant neoplasm of overlappingsites of oropharynx, (2) ICD-10 Condition: C102||Malignant neoplasm of lateral wallof oropharynx, (3) ICD-10 Condition: C103||Malignant neoplasm of posterior wall of oropharynx, (4) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, (5) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (6) ICD-10 Condition: C090||Malignant neoplasm of tonsillar fossa, (7) ICD-10 Condition: C091||Malignant neoplasm of tonsillar pillar (anterior) (posterior), (8) ICD-10 Condition: C051||Malignant neoplasm of soft palate, |
|
Intervention / Comparator Agent
Modification(s)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with cervical lymph node metastasis from oropharyngeal cancer or Carcinoma of Unknown Primary Site
2) FNAC and Core Needle Biopsy available
3) FNAC should have adequate tissue in cell blocks
4) Informed and written consent obtained |
|
| ExclusionCriteria |
| Details |
1) Non squamous histology
2) Inadequate material for immunohistochemistry and mRNA ISH in cell blocks and biopsies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To assess HR HPV status in metastatic squamous cell carcinoma in cervical lymph nodes
2) To determine the ideal specimen to be obtained for determining HR HPV status in metastatic squamous cell carcinoma to cervical lymph nodes, FNAC v/s Core Needle Biopsy
3) To identify the best technique for detection of HR HPV in metastatic squamous cell carcinoma to cervical lymph nodes |
1 year 8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) To determine the prevalence of HR HPV in metastatic squamous cell carcinoma to cervical lymph nodes with or without a clinically or radiologically detected primary lesion in oropharynx |
1 year 8 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
27/09/2024 |
| 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="8"
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
|
This is a prospective observational study comparing efficacy of pPCR, mRNA ISH and p16 IHC for detection of high risk HPV on fine needle aspirates and core needle biopsies in patients with metastatic squamouc cell carcinoma from oropharynx or unknown primary site to cervical lymph nodes that will be conducted in AIIMS New Delhi and NCI Jhajjar over a period of 2 years. Primary objectives includes assessment of HR HPV status in cervical lymph node metastasis, determination of ideal specimen and best techniqoe for the same. Secondary objective include determination of HR HPV prevalence in squamous cell carcinoma metastasising to cervical lymph nodes.
|