Corelation of distance of breast tumor to nipple areola with axillary node involvement.

Not yet recruiting

• Conditions: Malignant neoplasm of breast of unspecified site,

• Registration Number: CTRI/2023/11/060190
• Lead Sponsor: Aditya Sriharsha Pedaprolu

Brief Summary

Breast cancer stands as the most prevalent form of cancer among women. This type of cancer often advances without noticeable symptoms, making routine screenings or self-examinations crucial for its detection. We hope to analyse whether tumour location (quadrants) and tumour–nipple distance can help in predicting axillary node positivity by using current data of patients that will be a part of our cross-sectional observational study. will be conducted on patients with Carcinoma of the breast, primarily T1 and T2 patients, according to the 8th A.J.C.C Classification of T.N.M staging. In this study, 35 patients will be included and the outcomes will be recorded and analysed at the end of the study. we aimto determine the correlation between the mean distance of the tumour and nipple-areola complex and nodal positivity of axillary lymph nodes. If we can demonstrate a correlation, this study may help to prevent needless axillary nodal dissection procedures. It could also help to reduce the expense of the sentinel lymph node biopsy equipment and therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-12
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

• 1.Patients admitted at A.V.B.R.H for lump in breast.
• 2.Female patients aged 18 or older.
• 3.Female breast cancer patients exhibiting intact, uninvaded skin of the nipple and areola.
• 4.Individuals diagnosed pathologically and radiologically with early-stage invasive breast cancer, devoid of distant metastasis.
• 5.Patients who have not previously undergone neoadjuvant chemotherapy, endocrine therapy, or targeted therapy.
• 6.Patients who express willingness to undergo Modified Radical Mastectomy.
• 7.Patients with no history of prior breast or axillary surgery.

Exclusion Criteria

Pregnant status Prior occurrence of any malignant tumor within the last five years History of previous breast surgery Diagnosis of multi-center, multifocal, or bilateral breast cancer, as well as ductal carcinoma in situ The presence of severe systemic illness or dysfunction in any organ Patients currently receiving or having received adjuvant chemotherapy, endocrine therapy, or targeted therapy.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The decision to perform or avoid axillary clearance can be determined by assessing the tumor location and measuring the distance between the tumor and the nipple-areolar complex.	3 month pre and post operative period

Secondary Outcome Measures

Name	Time	Method
n/a	n/a

Trial Locations

Locations (1)

Datta Meghe Institute of Higher Education and Research; 🇮🇳 Wardha, MAHARASHTRA, India

Datta Meghe Institute of Higher Education and Research

🇮🇳Wardha, MAHARASHTRA, India

Dr Aditya Sriharsha Pedaprolu

Principal investigator

9167270209

adi.sriharsha@gmail.com