| CTRI Number |
CTRI/2013/04/003525 [Registered on: 01/04/2013] Trial Registered Retrospectively |
| Last Modified On: |
12/12/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Human Papilloma Virus in Head and Neck Cancer: Clinico-pathological Outcome |
|
Scientific Title of Study
|
HPV in Head Neck Squamous Cell Carcinoma (HN-SCC) - Clinico- Pathologic management correlation : An Observational Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Samir Bhattacharyya |
| Designation |
HOD, Dept. of Surgical Oncology |
| Affiliation |
Saroj Gupta Cancer Centre and Research Institute |
| Address |
Saroj Gupta Cancer Centre and Research Institute
Mahatma Gandhi Road
Thakurpukur
Kolkata-700063
South Twentyfour Parganas
WEST BENGAL
700063
India |
| Phone |
9831142992 |
| Fax |
|
| Email |
drsamir30951@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Inderdeep Singh |
| Designation |
DNB Student, Dept. of Surgical Oncology |
| Affiliation |
Saroj Gupta Cancer Centre and Research Institute |
| Address |
Saroj Gupta Cancer Centre and Research Institute
Mahatma Gandhi Road
Thakurpukur
Kolkata-700063
South Twentyfour Parganas
WEST BENGAL
700063
India |
| Phone |
9831142992 |
| Fax |
|
| Email |
singhdocinder@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samir Bhattacharyya |
| Designation |
HOD, Dept. of Surgical Oncology |
| Affiliation |
Saroj Gupta Cancer Centre and Research Institute |
| Address |
Saroj Gupta Cancer Centre and Research Institute
Mahatma Gandhi Road
Thakurpukur
Kolkata-700063
South Twentyfour Parganas
WEST BENGAL
700063
India |
| Phone |
9831142992 |
| Fax |
|
| Email |
drsamir30951@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| National Institute of Biomedical Genomics |
|
|
Primary Sponsor
|
| Name |
Cancer Centre Welfare Home and Research Institute |
| Address |
Mahatma Gandhi Road
Kolkata 700063 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| National Institute of Biomedical Genomics |
Netaji Subhash Sanatorium (TB Hospital), 2 Floor, PO NSS Kalyani 741251, West Bengal |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Samir Bhattacharya |
Dept of surgical Oncology,Saroj Gupta Cancer Centre and Research Insitutute |
Mahatma Gandhi Road,
Thakurpukur,
Kolkata- 700063
South Twentyfour Parganas
WEST BENGAL |
9831142992
drsamir30951@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Saroj Gupta Cancer Centre and Research Institute (Formerly, Cancer Centre Welfare Home and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Head and Neck Cancers - HPV presence and viral load estimstion, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients diagnosed as suffering from HNSCC presenting in the Institute |
|
| ExclusionCriteria |
| Details |
1) Immunocompromised patients:
a) Previous chemotherapy due to any cancer
b) Immunodeficiency status-latrogenic or disease indused
2) Previous Radiotherapy due to any cause
3) Where adequate biopsy sample cannot be obtained due to technical reasons
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HPV type and load related differences in disease progression and treatment response in HNSCC |
3 years of recruitment followed by further 2 yrs of of follow up after the last recruitment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Site of Recurrence and time interval of recurrence following treatment of HNSCC dependant on HPV Subtype and viral load. |
3 years of recruitment followed by further 2-5 yrs of of follow up after the last recruitment. |
|
|
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)
|
08/11/2012 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Cancer of the head and neck region is the commonest cancer in India and is the Commonest cause of cancer related death in India. Nearly 90% of cancers in the head and neck region is known as head and neck squamous cell Carcinoma- HNCC. A particular type of viral infection caused by Human Papilloma Virus is a common cause of HNSCC. The study aims to find out the following-To determine the overall incidence of various subtypes & viral load of HPV among HNSCC patients presenting in SGCCRI, Thakurpukur; To find out the relative incidences and viral load of virulent sub types of HPV in different sub-sites of HNSCC; Demographic and sub site analysis of the HPV- positive and HPV- negative HNSCC patients; Correlation between duration of symptoms and stage at presentation, between HPV (virulent sub types) positive & negative HNSCC patients. Secondarily it aims to find the : Treatment response, Time of recurrence, Nature of recurrence etc
Meterials and Methods: Patients who are selected to be enrolled in the study are questioned and their clinical and Demographic data are recorded as per proforma; 5mm of fresh HNSCC tissue will be collected in proper collection medium and stored in -80 degree centigrade. DNA isolation will be done using standard kits. PCR based HPV detection and typing will be done. Quantitative viral load will be done by RT-PCT
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