| 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
|
|
|
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
|
|
|
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 .
|