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Clinical Trials/CTRI/2025/08/092485
CTRI/2025/08/092485Not yet recruitingNot Applicable

A STUDY OF CLINICAL SIGNIFIANCE OF SERUM PROSTATE SPECIFIC ANTIGEN IN BREAST CANCER PATIENTS- A ONE YEAR OBSERVATIONAL STUDY.

Dr Gaddam Rishitha1 site in 1 country24 target enrollmentStarted: August 20, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
24
Locations
1
Primary Endpoint
To compare serum Prostrate specific antigen values in breast cancer patients and healthy females

Study Overview

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 .

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Female patients confirmed to have invasive breast cancer and those willing to give consent for the same .

Exclusion Criteria

  • Patients who denied the procedure .
  • Patients who present with a lump in the breast whose tissue diagnosis revealed they were benign .
  • Patients with uterine pathologies Immunocompromised patients.

Outcomes

Primary Outcomes

To compare serum Prostrate specific antigen values in breast cancer patients and healthy females

Time Frame: Preoperative - with in 8 weeks from surgery

Secondary Outcomes

  • To know the significance of serum Prostrate specific antigen in breast cancer patients .(Preoperative , within 8 weeks from surgery)

Investigators

Sponsor
Dr Gaddam Rishitha
Sponsor Class
Other [self ]
Responsible Party
Principal Investigator
Principal Investigator

Dr Gaddam Rishitha

KLE University Jawaharlal Nehru Medical College

Study Sites (1)

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