| CTRI Number |
CTRI/2023/11/060190 [Registered on: 23/11/2023] Trial Registered Prospectively |
| Last Modified On: |
22/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Corelation of distance of breast tumor to nipple areola with axillary node involvement. |
|
Scientific Title of Study
|
Clinical and sonological correlation between the distance of the tumour to the nipple-areola complex with axillary nodal involvement in a case of Carcinoma of the breast. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditya Sriharsha Pedaprolu |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of General Surgery, Shalinitai Meghe Superspeciality Hospital, Sawangi (Meghe), Wardha
Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9167270209 |
| Fax |
|
| Email |
adi.sriharsha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Venkatesh Manohar Rewale |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of General Surgery, Shalinitai Meghe Superspeciality Hospital, Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8007887196 |
| Fax |
|
| Email |
drvmrewale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Venkatesh Manohar Rewale |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of General Surgery, Shalinitai Meghe Superspeciality Hospital, Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8007887196 |
| Fax |
|
| Email |
drvmrewale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of higher education and research |
|
|
Primary Sponsor
|
| Name |
Aditya Sriharsha Pedaprolu |
| Address |
Datta Meghe Institute of Higher Education and Research Sawangi Wardha Maharashtra (442001) India |
| 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 Aditya Sriharsha Pedaprolu |
Datta Meghe Institute of Higher Education and Research |
Department of Sugery, Shalinitai meghe Super speciality Centre, Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA |
9167270209
adi.sriharsha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee , Datta Meghe Institute of Medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
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.
8. Patients classified as T1 or T2 based on the 8th edition of the AJCC TNM staging system.
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| n/a |
n/a |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
01/12/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 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. |