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CTRI Number  CTRI/2019/07/020350 [Registered on: 24/07/2019] Trial Registered Prospectively
Last Modified On: 03/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Study of tumor development by Laser Based study using Breast cancer samples. 
Scientific Title of Study   Establishment of Patient-Derived Breast tumor Xenograft and assessment of tumor progression by photoacoustic spectroscopy ex vivo. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr K K Mahato 
Designation  Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Dept. of Biophysics, Manipal School of Life Sciences, Manipal Academy of Higher Education, Manipal Udupi - 576104 Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9448836553  
Fax    
Email  mahato.kk@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Jackson Rodrigues 
Designation  Ph.D Scholar 
Affiliation  Manipal Academy of Higher Education 
Address  Dept. of Biophysics, Manipal Schoo of Life Sciences, Manipal Academy of Higher Education, Manipal Udupi - 576104 Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9535620699  
Fax    
Email  jackson.rodrigues777@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vijendra Prabhu 
Designation  Assistant professor 
Affiliation  Manipal Institute of Technology, MAHE 
Address  Department of Biotechnology, Manipal Institute of Technology, MAHE, Manipal, Udupi - 576104 Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9986168674  
Fax    
Email  vijendra.prabhu@manipal.edu  
 
Source of Monetary or Material Support  
INDIAN COUNCIL OF MEDICAL RESEARCH (ICMR) V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Stanley Mathew  Kastruba Hospital, Manipal  Department of Surgery Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal-576 104
Udupi
KARNATAKA 		 9844409900

stanley.mathew@manipal.edu 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  Diagnosed with malignant or premalignant breast cancer 
 
ExclusionCriteria 
Details  individual with any other disease not related to cancer. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Patient-Derived xenograft models retain the principal histologic and genetic characteristic of the donor patient’s tumor. Hence, the proposed study might reveal the complications on the early detection as well as progression of the breast tumor, based on the photoacoustic signatures. These techniques may have translational significance with further refinement and preclinical explorations.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
These techniques may have translational significance with further refinement and preclinical explorations.  1 year 
 
Target Sample Size
Modification(s)  		 Total Sample Size="10"
Sample Size from India="10" 
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)   02/08/2019 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Priya, M., Rao, B. S. S., Chandra, S., Datta, A., Nayak, S. G., & Mahato, K. K. (2015). Monitoring breast tumor progression by photoacoustic measurements: a xenograft mice model study. Journal of biomedical optics, 20(10), 1-10. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Breast cancer is a deadly disease and the most frequent cause of cancer death among women globally. The breast tumor can be detected using techniques such as X-Ray, MRI techniques, etc. But, these techniques come with limitations like false negative results and other side effects. Therefore, in addition to the currently available radiological screening tools, alternative strategies to improve the early detection procedures are highly recommended. Photoacoustic spectroscopy is a sensitive technique which works on the principle of absorption of electromagnetic radiation. With this technique, it is possible to distinguish the tumor and normal tissues without requiring preparation of the sample, in a non-invasive way using non-ionizing radiation. In the future, this technique can be used in the prognosis of Breast cancer if the current study can uncover significant photoacoustic signatures in human samples. Since Patient-Derived Xenograft (PDX) models retain the principal histologic and genetic characteristics of the donor patient’s tumor, the photoacoustic studies on humanized samples can provide us valuable information and would be a powerful tool to predict clinical conditions in humans. 
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