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CTRI Number  CTRI/2025/08/092485 [Registered on: 06/08/2025] Trial Registered Prospectively
Last Modified On: 03/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   A clinical trail to study the significance of serum prostrate specific antigen in breast cancer patients In belagavi , Karnataka - A one year observational study . 
Scientific Title of Study   A STUDY OF CLINICAL SIGNIFIANCE OF SERUM PROSTATE SPECIFIC ANTIGEN IN BREAST CANCER PATIENTS- A ONE YEAR OBSERVATIONAL STUDY. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gaddam Rishitha  
Designation  Junior Resident  
Affiliation  KLE University Jawaharlal Nehru Medical College  
Address  Department Of General Surgery KLE Jawaharlal Nehru Medical College Belgaum . Belgaum .

Belgaum
KARNATAKA
590010
India 
Phone  9360565656  
Fax    
Email  g.rishithareddy99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ramesh S Koujalagi  
Designation  Professor  
Affiliation  KLE University Jawaharlal Nehru Medical College 
Address  Department Of General Surgery KLE Jawaharlal Nehru Medical College, Belgaum.

Belgaum
KARNATAKA
590010
India 
Phone  8970738515  
Fax    
Email  drrameshkoujalagi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ramesh S Koujalagi  
Designation  Professor  
Affiliation  KLE University Jawaharlal Nehru Medical College 
Address  Department Of General Surgery KLE Jawaharlal Nehru Medical College, Belgaum.

Belgaum
KARNATAKA
590010
India 
Phone  8970738515  
Fax    
Email  drrameshkoujalagi@gmail.com  
 
Source of Monetary or Material Support  
Dr Gaddam Rishitha , Jawaharlal Nehru Medical College  
 
Primary Sponsor  
Name  Dr Gaddam Rishitha 
Address  Department Of General Surgery , KLE Jawaharlal Nehru Medical College , Belgaum , Karnataka , India, 590010. 
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 Gaddam Rishitha  KLE Dr. Prabhakar Kore Hospital and Medical Research Centre   Department Of General Surgery ,KLE jawaharlal Nehru Medical College, Belgaum.
Belgaum
KARNATAKA 
9360565656

g.rishithareddy99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50||Malignant neoplasm of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  Female patients confirmed to have invasive breast cancer and those willing to give consent for the same .  
 
ExclusionCriteria 
Details  Patients who denied the procedure .
Patients who present with a lump in the breast whose tissue diagnosis revealed they were benign .
Patients with Ovarian pathologies .
Patients with uterine pathologies
Immunocompromised patients  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare serum Prostrate specific antigen values in breast cancer patients and healthy females   Preoperative - with in 8 weeks from surgery  
 
Secondary Outcome  
Outcome  TimePoints 
To know the significance of serum Prostrate specific antigen in breast cancer patients .  Preoperative , within 8 weeks from surgery  
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   20/08/2025 
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="1"
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  

Breast cancer is the most common malignancy in women worldwide and one of the leading causes of cancer death . Triple negative breast cancer is defined by the lack of estrogen and progesterone receptors as well as an absence of HER2 (human epidermal growth factor receptor 2) amplification. Because of the lack of specific targeted therapy, 30–40% of patients with early-stage TNBC develop metastatic disease and succumb to the cancer, despite receiving standard multi-agent adjuvant chemotherapy  .Both molecular and immunohistochemical analyses demonstrate that a subset of TNBC expresses androgen resistance [ AR ] . AR dependency has also been suggested in a subset of ER-negative, AR-positive breast cancers. Recently, numerous preclinical studies have validated the use of AR modulation in limiting cell proliferation, growth on soft agar, and tumor initiation in vivo and there are ongoing clinical trials evaluating the efficacy of AR antagonists in ER- negative breast cancer for bicalutamide, enzalutamide.

In this study, we investigate whether sPSA might reflect tumor biology, including AR signaling. Using blood samples from both healthy controls and breast cancer patients, individuals were enrolled regardless of age clinicopathological factor or treatment history. sPSA was evaluated by chemiluminescent enzyme immunoassay (CLEIA) method at various timepoints for each case. Then correlations between sPSA and clinicopathological factors were analyzed .


 
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