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CTRI Number  CTRI/2024/01/062150 [Registered on: 31/01/2024] Trial Registered Prospectively
Last Modified On: 20/02/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Study on cancer in older adults (more than 60 years)  
Scientific Title of Study   “Characteristics of Geriatric Cancers and Treatment in a Tertiary Cancer Center” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sharada Mailankody  
Designation  Associate Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Dept of Medical Oncology, Shirdi Sai Cancer Hospital, Kasturba Medical College, Madhavnagar, Manipal 576104

Udupi
KARNATAKA
576104
India 
Phone  9787689031  
Fax    
Email  sharadajayaram27@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sharada Mailankody  
Designation  Associate Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Dept of Medical Oncology, Shirdi Sai Cancer Hospital, Kasturba Medical College, Madhavnagar, Manipal 576104

Udupi
KARNATAKA
576104
India 
Phone  9787689031  
Fax    
Email  sharadajayaram27@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sharada Mailankody  
Designation  Associate Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Dept of Medical Oncology, Shirdi Sai Cancer Hospital, Kasturba Medical College, Madhavnagar, Manipal 576104

Udupi
KARNATAKA
576104
India 
Phone  9787689031  
Fax    
Email  sharadajayaram27@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College,Madhavnagar, Manipal 576104, Karnataka. 
 
Primary Sponsor  
Name  Sharada Mailankody  
Address  Dept of Medical Oncology, Kasturba Medical College, Manipal, 576104 
Type of Sponsor  Other [Self] 
 
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 
Dr Sharada Mailankody   Kasturba Medical College, Manipal   Department of Medical Oncology, Shirdi Sai Cancer Block, Kasturba Medical College, Manipal 576104
Udupi
KARNATAKA 		 9787689031

sharadajayaram27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL   Observational study  
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.99 Year(s)
Gender  Both 
Details  All patients who are 60 years or older with cancer, are registered in our hospital till study conclusion  
 
ExclusionCriteria 
Details  Patients who choose to get treatment elsewhere  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
characteristics and treatment outcomes of geriatric patients in our cancer center  At 2 months of enrolment 
 
Secondary Outcome  
Outcome  TimePoints 
Treatment toxicities and associated factors   At 2 months of enrolment  
 
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)   01/02/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sharadajayaram27@gmail.com].

  6. For how long will this data be available start date provided 26-01-2024 and end date provided 26-01-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

The Indian population dynamics are changing and cancer incidence in India is increasing.[1,2] Increasing age itself is a risk factor for cancer. In addition, India has a distinct pattern of cancer care practices and available infrastructure, leading to unique challenges in cancer treatment.[3]

Older patients with cancer may have multiple other comorbidities, different cancer biology and other psychosocial and logistic issues, and require detailed assessment of all factors before treatment initiation.[4-7]. Ideally, geriatric patients should undergo a comprehensive geriatric assessment, which covers all the domains of functioning of an older adult.[5] Geriatric assessment can improve outcomes of treatment by optimizing treatment, preventing under treatment and overtreatment.

However, there is only very little data from India on the disposition of geriatric patients with cancer.[4,7] Understanding the characteristics of geriatric patients with cancer will help us to plan our treatment better. Identification of the burden of geriatric oncology in our practice and the barriers to treatment in older patients will help us to plan interventions to improve outcomes.

 
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