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CTRI Number  CTRI/2017/08/009358 [Registered on: 14/08/2017] Trial Registered Prospectively
Last Modified On: 16/11/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Utility of telephone based questionnaire in detecting oral cancer recurrences 
Scientific Title of Study   A prospective observational study to evaluate the value of nurse led telephone based questionnaire in detecting recurrences in patients who have completed curative-intent treatment for oral cancers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sudhir Nair 
Designation  Associate Professor 
Affiliation  Tata Memorial Centre 
Address  Department of Head Neck Oncology, 12th floor, Homi Bhabha Block, Tata Memorial Centre, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  sudhirvr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sudhir Nair 
Designation  Associate Professor 
Affiliation  Tata Memorial Centre 
Address  Department of Head Neck Oncology, 12th floor, Homi Bhabha Block, Tata Memorial Centre, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  sudhirvr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sudhir Nair 
Designation  Associate Professor 
Affiliation  Tata Memorial Centre 
Address  Department of Head Neck Oncology, 12th floor, Homi Bhabha Block, Tata Memorial Centre, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  sudhirvr@gmail.com  
 
Source of Monetary or Material Support  
Tata memorial centre, Dr E Borges Marg, Parel, Mumbai 400012 
 
Primary Sponsor  
Name  Tata Memorial Centre 
Address  Tata Memorial Centre, Parel Mumbai, Maharashtra 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sudhir Nair  Tata Memorial Centre  Dept of Head & Neck Oncology, 12 th floor, Homi Bhabha Block, Parel, Mumbai
Mumbai
MAHARASHTRA 
9769617780

sudhirvr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee II  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, Patients of oral cancer who hve completed their curative intent treatment and are on follow up,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients having diagnosed oral cancer
2. Completed potentially curative treatment
3. On follow up for >2 months and <2 years after finishing treatment

 
 
ExclusionCriteria 
Details  Exclusion Criteria
1. ECOG>2 (recurrence may not be treated with curative intent)
2. <18 years, > 80 years (<18 – for consent, > 80 as recurrence may not be treated with curative intent)
3. Patients already diagnosed with recurrent disease
4. Already assessed once for the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Sensitivity of a nurse led telephonic questionnaire to pick up recurrences  at 2 years 
 
Secondary Outcome  
Outcome  TimePoints 
1. To estimate the proportion of asymptomatic patients with recurrent disease on routine (intensive) follow up
2. Salvage rate- of patients detected with recurrence
3. DFS at 2 years of patients having recurrence – the patients detected to have recurrence will be followed for two years and the disease free survival noted
4. Patients’ acceptability of following up 6 monthly
 
2 years 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   01/10/2017 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Oral cancers are the commonest cancers in the Indian sub-continent. After finishing oncologic treatment these patients are generally followed up three monthly for first two years, six monthly for next three years and annually thereafter. In any oncology set up, follow up assessment of such patients forms the major work load in the out-patient department. It has been observed that patients can identify new symptoms indicating recurrence. Symptoms mentioned by patients help in diagnosing majority of recurrences (66-80%) No change was seen in DFS and OS between the groups where recurrence was detected by patient versus the doctor. In a study, where they evaluated 3645 patient visits, it was found that recurrence/ second primary was suspected in 5% of the patients. 79% of the patients suspected to have a recurrence had identified new symptoms themselves. In absence of symptoms, recurrence was rare and seen in only 1.2% of the patients.  A study on head and neck cancer patients showed that recurrence was suspected in only 10% of patients seen routinely and in 68% of those who requested for a consultation. They found that 56% of those who requested for a consultation actually had a recurrence, whereas recurrence was found to be there in only 0.3% of asymptomatic patients.  There are other studies which have shown that when followed up for 5 years, loco-regional recurrence may be seen in 25-50% of the patients and second primaries in 3-5%  of the cases. According to another study, ‘numbers needed to see’ to detect one asymptomatic recurrence was 99.  It has been seen that even when patients are followed up intensively, salvage therapy remains feasible in only 20-65% of them The salvage rates depend upon the sub-site and whether the recurrences are local or regional or loco-regional. Local recurrences generally fare better than regional ones. It has also been observed that patients tend to wait for their regular follow up rather than present early when they detect a symptom. When patients with recurrences who have been salvaged are followed up 3 and 5 year overall survival has been found to be about 52.6% and 48% respectively. Majority of the data available is from the more developed countries. In Indian sub-continent, the patients are not that well educated and don’t have ample resources to make frequent long distance trips for frequent surveillance. Data is scarce regarding the exact proportion of asymptomatic patients who are detected with recurrence on routine clinical examination, the salvage rates of patients detected to have recurrent disease and the outcomes of salvage treatment. We intend to gather data related to asymptomatic recurrences and the sensitivity of telephone based questionnaire in detecting recurrences in patients of oral cancer after finishing the curative intent treatment.


Hypothesis: A nurse led telephone-based interview can reliably identify patients at risk for recurrence on follow up after radical treatment with oral cancers

 
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