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CTRI Number  CTRI/2025/03/082596 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 11/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Genetic testing and counseling for adults to detect and manage hereditary cancer risk. 
Scientific Title of Study   Comprehensive evaluation of genetic counseling and genetic testing in diagnosis and management of adult-onset hereditary cancer syndromes: A mixed method study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lakshmi Priya Rao 
Designation  PhD Scholar 
Affiliation  Kasturba Medical College and Hospital, Manipal. 
Address  Room number 2, Department of Medical Oncology, Fourth floor, Shirdi Sai Baba Cancer Hospital and Research Centre, Kasturba Medical College and Hospital, Manipal Academy of Higher Education, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  8147660831  
Fax    
Email  lakshmi.priya@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Karthik S Udupa 
Designation  Professor and Head Unit 1 
Affiliation  Kasturba Medical College and Hospital, Manipal. 
Address  Room number 6, Department of Medical Oncology, Fourth floor, Shirdi Sai Baba Cancer Hospital and Research Centre, Kasturba Medical College and Hospital, Manipal Academy of Higher Education, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9845317153  
Fax    
Email  udupa.karthik@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Lakshmi Priya Rao 
Designation  PhD Scholar 
Affiliation  Kasturba Medical College and Hospital, Manipal. 
Address  Room number 2, Department of Medical Oncology, Fourth floor, Shirdi Sai Baba Cancer Hospital and Research Centre, Kasturba Medical College and Hospital, Manipal Academy of Higher Education, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  8147660831  
Fax    
Email  lakshmi.priya@manipal.edu  
 
Source of Monetary or Material Support  
Department of Medical Oncology, Fourth floor, Shirdi Sai Baba Cancer Hospital and Research Centre, Kasturba Medical College and Hospital, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India - 576104.  
 
Primary Sponsor  
Name  Lakshmi Priya Rao 
Address  Room Number 2, Department of Medical Oncology, Fourth floor, Shirdi Sai Baba Cancer Hospital and Research Centre, Kasturba Medical College and Hospital, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India - 576104.  
Type of Sponsor  Other [Self Sponsored] 
 
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 
Lakshmi Priya Rao  Kasturba Medical College and Hospital.  Room Number 2, Department of Medical Oncology, Fourth floor, Shirdi Saibaba Cancer Hospital and Research Centre, Kasturba Medical College and Hospital, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India 576104.
Udupi
KARNATAKA 		 8147660831

lakshmi.priya@manipal.edu 
 
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, (2) ICD-10 Condition: D49-D49||Neoplasms of unspecified behavior,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients over eighteen years and above with a histopathologically confirmed diagnosis of cancer referred by oncologists, with the majority fulfilling NCCN criteria, and willing to participate in the study.
Any family members who are first-degree relatives of an affected individual with the criteria as mentioned above, who are over 18 years and above.
Health care professionals like Surgical Oncologists, Radiation Oncologists, Palliative care Oncologists, Pediatric Oncologists, Gynecologists, and General surgeons who have experience of treating cancer patients for five or more years. 
 
ExclusionCriteria 
Details  Patients with paediatric onset cancers.
Patients not opting for genetic testing.
Patients and first-degree relatives with disability (where the term ‘person with disability’ has been defined under section 2(s) of The Rights of Persons with Disabilities (RPwD)
Act, 2016).
No exclusion criteria for health care professionals. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improve knowledge and awareness about genetic counseling and genetic testing for hereditary cancer syndromes  24 months 
 
Secondary Outcome  
Outcome  TimePoints 
Improving patient outcomes and health outcomes.
Understanding experiences of genetic counseling and testing.
Elucidation of molecular landscape and phenotype-genotype correlation of adult-onset cancers in the Indian population. 		 24 months 
 
Target Sample Size   Total Sample Size="294"
Sample Size from India="294" 
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)   24/03/2025 
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)  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  
Genetic counseling and testing are currently considered the standard of care for hereditary malignancies, helping with therapy optimization and family screening. However, considerable barriers to deploying genetic counseling services in low- and middle-income countries limit their acceptance. These limitations include inadequate accessibility, a scarcity of skilled professionals, and a lack of awareness and expertise among both healthcare practitioners and patients. Existing research has consistently indicated a lack of awareness and comprehension of genetic counseling among stakeholders as a key barrier, underlining the need for tailored services. In India, developing and integrating cancer genetic counseling services into tertiary care hospitals is critical to overcome these limitations. This study seeks to address this gap by evaluating genetic counseling and broad-spectrum genetic testing in adult-onset hereditary cancers by quantitative and qualitative methods. By analyzing outcomes such as stakeholder knowledge and awareness, attitude and perception, the study achieves its primary goal of correcting educational gaps and encouraging informed decision-making. Furthermore, assessing health outcomes will provide crucial insights into the utility of these services, thereby giving valuable data to improve policy and practice. The burden of hereditary cancer syndromes (HCSs) is not well defined in India, and defining the mutational landscape leads to improved health benefits.
 
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