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CTRI Number  CTRI/2025/09/094661 [Registered on: 12/09/2025] Trial Registered Prospectively
Last Modified On: 20/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Circulating Tumor Cells as Biomarker for Monitoring Treatment Response After Surgery in Early Breast Cancer Patients -Towards Improving Patient Well Being 
Scientific Title of Study   Circulating Tumor Cells as Biomarker for Monitoring Treatment Response After Surgery in Early Breast Cancer Patients Towards Improving Patients Well Being 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rakesh S Ramesh 
Designation  Professor 
Affiliation  St Johns Medical college Hospital, Bengaluru 
Address  31 E ,Department of Surgical Oncology ,St Johns Medical college Hospital, Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  9980007455  
Fax    
Email  srakesh99@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Rakesh S Ramesh 
Designation  Professor 
Affiliation  St Johns Medical college Hospital, Bengaluru 
Address  31 E, Department of Surgical Oncology ,St Johns Medical college Hospital, Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  9980007455  
Fax    
Email  srakesh99@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Rakesh S Ramesh 
Designation  Professor 
Affiliation  St Johns Medical college Hospital, Bengaluru 
Address  31 E,Department of Surgical Oncology ,St Johns Medical college Hospital, Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  9980007455  
Fax    
Email  srakesh99@yahoo.co.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Rakesh S Ramesh 
Address  St. John’s Medical College Hospital St. John’s National Academy of Health Sciences Sarjapur Road, John Nagar, Koramangala Bengaluru – 560 034, Karnataka, India 
Type of Sponsor  Other [NIL] 
 
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 Rakesh S Ramesh  St Johns Medical College Hospital  C2-2 ,Surgical Oncology ward, St. John’s Medical College Hospital St. John’s National Academy of Health Sciences Sarjapur Road, John Nagar, Koramangala Bengaluru – 560 034, Karnataka, India
Bangalore
KARNATAKA 		 9980007455

srakesh99@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee St Johns National Academy of Health Sciences Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C500||Malignant neoplasm of nipple and areola, (2) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast, (3) ICD-10 Condition: C502||Malignant neoplasm of upper-innerquadrant of breast, (4) ICD-10 Condition: C503||Malignant neoplasm of lower-innerquadrant of breast, (5) ICD-10 Condition: C504||Malignant neoplasm of upper-outerquadrant of breast, (6) ICD-10 Condition: C505||Malignant neoplasm of lower-outerquadrant of breast, (7) ICD-10 Condition: C506||Malignant neoplasm of axillary tail of breast, (8) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  nil 
Intervention  Surgery   Pre- operative samples will collected for circulating tumor cells followed by surgery. ,24 hours after surgery blood sample will be collected for checking the CTC .  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Male and female breast cancer patients
2.Patients undergoing Breast conservation surgery, Modified radical mastectomy or Simple mastectomy
3.Patients undergone neoadjuvant chemotherapy
4.Ductal & Lobular carcinoma – In situ or Invasive
 
 
ExclusionCriteria 
Details  1.Second surgery
2.Recurrent disease
3.Metastatic disease
4.Benign breast lumps, sarcoma

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Fall in CTC after Surgical intervention in Breast Cancer Patients , Reduction in cancer worry as Patient reported outcome measure after surgery, Minimum Residual Disease burden will be reduced there b y improving the survival of breast cancer patients.   1.Baseline (Pre-surgery):

First CTC blood sample collection (to establish baseline CTC count).

Assessment of cancer worry (Patient Reported Outcome Measure – PROM).

2.24 hours post-surgery:

Second CTC blood sample collection.

Assessment in cancer worry (PROM).

 
 
Secondary Outcome  
Outcome  TimePoints 
NIll   NIll  
 
Target Sample Size
Modification(s)  		 Total Sample Size="48"
Sample Size from India="48" 
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)   08/10/2025 
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="6"
Days="5" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
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 -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [srakesh99@yahoo.co.in].

  6. For how long will this data be available start date provided 08-10-2025 and end date provided 08-06-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Breast cancer is one of the most common cancers globally and a leading cause of cancer-related mortality in India, with an incidence rate of 25–30 per 100,000 women in urban areas and 10–15 per 100,000 in rural areas. Metro cities such as Hyderabad, Delhi, Mumbai, and Bangalore are the most affected, with Indian women being diagnosed nearly 10 years earlier than their Western counterparts, typically between 40–50 years of age. Alarmingly, around 60% of breast cancer cases in India are diagnosed at an advanced stage (Stage III/IV), leading to poor outcomes, with the 5-year survival rate being only 66%. Contributing factors include lack of awareness, late detection, and limited access to healthcare services. Early treatment response monitoring is essential for improving clinical outcomes and guiding personalized care. Currently, imaging remains the primary tool to assess treatment response, disease progression, and recurrence risk; however, as breast cancer is a systemic disease, cancer cells may be circulating in the blood much earlier than changes are detectable on imaging. Circulating Tumor Cells (CTCs), which are shed from primary tumors into the bloodstream, are emerging as promising biomarkers, capable of providing real-time insights into treatment response, disease progression, and recurrence risk. Evaluating the role of surgery in reducing systemic tumor burden using CTCs as biomarkers can help optimize systemic treatment planning in early breast cancer patients. This study aims to investigate the role of CTCs as biomarkers in breast cancer patients undergoing surgery to assess tumor burden reduction post-surgery and to understand patient-reported outcome measures (PROM) related to cancer worry, thereby contributing towards improving patient well-being. 
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