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CTRI Number  CTRI/2025/01/079334 [Registered on: 24/01/2025] Trial Registered Prospectively
Last Modified On: 23/01/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Cancer of unknown primary (CUP STUDY)  
Scientific Title of Study   HNCIG/IFHNOS Carcinoma of Unknown Primary study 
Trial Acronym  HNCIG/IFHNOS CUP 
Secondary IDs if Any  
Secondary ID  Identifier 
HNCIG/IFHNOS CUP STUDY PROTOCOL VERSION 1.1 DATED 22.10.2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shivakumar Thiagarajan 
Designation  Professor, head and neck oncology E, MS (ENT) DNB  
Affiliation  Tata Memorial Hospital 
Address  1209 HOMI BHABA BLOCK TATA MEMORIAL HOSPITAL DR. ERNEST BORGES MARG PAREL MUMBAI

Mumbai
MAHARASHTRA
400012
India 
Phone  9846572399  
Fax    
Email  drshiva78in@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shivakumar Thiagarajan 
Designation  Professor, head and neck oncology E, MS (ENT) DNB  
Affiliation  Tata Memorial Hospital 
Address  1209 HOMI BHABA BLOCK TATA MEMORIAL HOSPITAL DR. ERNEST BORGES MARG PAREL MUMBAI

Mumbai
MAHARASHTRA
400012
India 
Phone  9846572399  
Fax    
Email  drshiva78in@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shivakumar Thiagarajan 
Designation  Professor, head and neck oncology E, MS (ENT) DNB  
Affiliation  Tata Memorial Hospital, Mumbai. 
Address  1209 HOMI BHABA BLOCK TATA MEMORIAL HOSPITAL DR. ERNEST BORGES MARG PAREL MUMBAI

Mumbai
MAHARASHTRA
400012
India 
Phone  9846572399  
Fax    
Email  drshiva78in@gmail.com  
 
Source of Monetary or Material Support  
TATA MEMORIAL HOSPITAL PAREL MUMBAI 400012 MAHARASHTRA  
 
Primary Sponsor  
Name  N/A 
Address  N/A 
Type of Sponsor  Other [N/A] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Australia
Portugal
Singapore
Spain
United Kingdom
United States of America  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shivakumar Thiagarajan  Tata Memorial Hospital  Dept of Head and Neck Oncology (OPD) (2nd floor Homi bhabha block and 107 golden jublee block) parel mumbai
Mumbai
MAHARASHTRA 		 9846572399

drshiva78in@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Tata memorial Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (2) ICD-10 Condition: C140||Malignant neoplasm of pharynx, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  72.00 Year(s)
Gender  Both 
Details  Are consecutive i.e. unselected undergoing either unilateral or bilateral tonsillectomy, tongue base mucosectomy, random biopsies, or guided biopsies for suspected HNSCCUP between 1st January 2015 and 31st December 2021
A minimum of 50 cases are required for centre participation
All HNC sites will be included e.g. oral, oropharyngeal, laryngopharyngeal and nasopharyngeal
Have unilateral or bilateral involved neck nodes
Have a minimum of 2-year follow up or less if the patient has died.
Have a diagnosis of squamous cell carcinoma on FNA or core biopsy or neck node biopsy or neck dissection
Must have cross sectional imaging, either CT, MRI, PET-CT or combination having a PET-CT is not mandatory
 
 
ExclusionCriteria 
Details  Have distant metastatic disease on presentation
Are less than 18 years old
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
a.In HNSCCUP non nasopharyngeal with unilateral neck disease what is the incidence of the primary tumour
being identified in the ipsilateral tongue base
b.To assess outcomes recurrence free survival and overall survival in a long term follow up study
c.To assess the difference in locoregional recurrence and overall survival in patients with T0N1 HNSCCUP
between those undergoing surgery or radiotherapy alone and those undergoing dual modality treatment 		 1.Compare outcomes of surgery, radiotherapy, and dual modality treatments, including survival and mortality.
2.Assess detection rates by geography, HPV p16 status, and prior tonsillectomy.
3.Provide 5 year survival and recurrence free data. 
 
Secondary Outcome  
Outcome  TimePoints 
a.To determine if the rate of tongue base primary detection varies dependent on patients having had prior tonsillectomy
b) In HNSCCUP with unilateral neck disease, what is the incidence of the primary tumour in the ipsilateral
tonsil, contralateral tonsil, or contralateral tongue base
c) In HNSCCUP with bilateral neck disease what is the incidence of the primary tumour in the ipsilateral
tonsil, contralateral tonsil, ipsilateral tongue base or contralateral tongue base
d) To describe the incidence of HNSCCUP by p16 and HPV status and geography
e) To determine the effect of treatment on outcomes specifically overall survival and 30-day mortality
f) Determine the rate of primary site diagnosis from targeted and untargeted biopsies 		 overall survival and 30-day mortality 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="50" 
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)   13/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  13/02/2025 
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 Yet Recruiting 
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 HNCIG/IFHNOS CUP Study focuses on improving the diagnosis and treatment of head and neck squamous cell carcinoma (HNSCC) with an unknown primary (HNSCCUP). This international collaboration aims to address diagnostic challenges, identify primary tumor sites, and assess treatment outcomes.

Key Objective

Define diagnostic pathways: Explore geographical variations in diagnostic practices and procedures.

Primary tumor detection: Report detection rates based on geography and p16/HPV status.

Treatment outcomes: Evaluate the effectiveness of surgery, radiotherapy, and combined treatments on survival and mortality.

Long-term outcomes: Provide 5-year survival and recurrence-free survival data.

Work Packages:

WP1 (International Survey): Identify geographical differences in diagnostic practices.

WP2 (Data Collection): Retrospective study on primary site detection, treatment effects, and survival outcomes.

WP3 (Delphi Consensus): Achieve international consensus on best practices for diagnosis and treatment.

Participants Surgeons, clinicians, and oncologists from international centers.

Data Collection Retrospective cohort with at least 50 cases per center.

Ethics Waiver of consent, using de-identified historical data.

Sample Size 82 patients for calculating primary site detection.

Confidentiality Anonymized data stored in a secure database for future research

 
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