| CTRI Number |
CTRI/2026/02/104406 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
CORRELATION OF CLINICAL EXAMINATION, RADIOLOGICAL IMAGING
AND HISTOPATHOLOGY IN THE DIAGNOSIS OF BREAST LUMP |
|
Scientific Title of Study
|
CORRELATION OF CLINICAL EXAMINATION, RADIOLOGICAL IMAGING
AND HISTOPATHOLOGY IN THE DIAGNOSIS OF BREAST LUMP |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
YUVRAJSINH MAHIDA |
| Designation |
JUNIOUR RESIDENT |
| Affiliation |
DATTA MEGHE MEDICAL COLLEGE, NAGPUR |
| Address |
GENERAL SURGERY DEPARTMENT, DATTA MEGHE MEDICAL COLLEGE, WANADONGRI, NAGPUR, MAHARASHTRA - 441110
GAMTALAV BUJRANG, MANDVI, SURAT, GUJARAT- 394163
Nagpur
MAHARASHTRA
441110
India |
| Phone |
08980440402 |
| Fax |
|
| Email |
ymahida1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Hardas |
| Designation |
PROFESSOR, GENERAL SURGERY |
| Affiliation |
DATTA MEGHE MEDICAL COLLEGE, NAGPUR |
| Address |
GENERAL SURGERY DEPARTMENT, DATTA MEGHE MEDICAL COLLEGE, WANADONGRI, NAGPUR, MAHARASHTRA 441110
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9823922589 |
| Fax |
|
| Email |
ajaynhardas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Hardas |
| Designation |
PROFESSOR, GENERAL SURGERY |
| Affiliation |
DATTA MEGHE MEDICAL COLLEGE, NAGPUR |
| Address |
GENERAL SURGERY DEPARTMENT, DATTA MEGHE MEDICAL COLLEGE, WANADONGRI, NAGPUR, MAHARASHTRA 441110
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9823922589 |
| Fax |
|
| Email |
ajaynhardas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shalinitai Meghe Hospital and Research centre, Wanadongri, Nagpur |
|
|
Primary Sponsor
|
| Name |
YUVRAJSINH MAHIDA |
| Address |
General Surgery Department, Datta Meghe Medical College, Wanadongri, Hingna, Nagpur |
| 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 |
| Yuvraj Mahida |
SHALINITAI MEGHE HOSPITAL AND RESEARCH CENTRE, NAGPUR |
OPD -3 , GENERAL SURGERY DEPARTMENT, SHALINITAI MEGHE HOSPITAL AND RESEARCH CENTRE, WANADONFRI, HINGNA, NAGPUR, 441110
Nagpur
MAHARASHTRA |
08980440402
ymahida1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMMITEE, DATTA MEGHE MEDICAL COLLEGE, NAGPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N630||Unspecified lump in unspecified breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
MORE THAN 15 YEARS OF FEMALE WITH LUMP IN BREAST
|
|
| ExclusionCriteria |
| Details |
Patients with breast trauma or infection (e.g., abscesses).
Pregnant or lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study aims to assess the correlation between clinical, radiological, and histopathological findings in palpable breast lumps.
It will evaluate the diagnostic accuracy of different modalities to identify cost-effective and reliable diagnostic pathways.
The findings may help in early detection of malignancy, reduce diagnostic delays, and improve patient outcomes.
The study will also provide locally relevant data to guide screening protocols and clinical practice. |
over a period of twenty-four months, from June 2025 to June 2027. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The findings may help in early detection of malignancy, reduce diagnostic delays, and improve patient outcomes.
The study will also provide locally relevant data to guide screening protocols and clinical practice. |
over a period of twenty-four months, from June 2025 to June 2027. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
02/03/2026 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included ymahida1@gmail.com).
- For how long will this data be available start date provided 02-02-2026 and end date provided 08-08-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Breast
lumps are a common clinical presentation with a wide spectrum ranging from
benign conditions to malignant lesions. Accurate and timely diagnosis is
essential to ensure early detection of malignancy while avoiding unnecessary
interventions for benign diseases. The triple assessment approach—clinical
examination, radiological imaging, and histopathological evaluation—is
considered the gold standard for breast lump evaluation.
This
hospital-based prospective observational study will be conducted at a tertiary
care centre to assess the clinical profile of patients presenting with palpable
breast lumps and to correlate radiological findings with histopathological
diagnosis. Female patients above 15 years with palpable breast lumps will be
included. Clinical examination, ultrasonography with BI-RADS classification,
and pathological evaluation using FNAC and/or biopsy will be performed.
The study
aims to evaluate the diagnostic accuracy of radiological imaging in
differentiating benign and malignant breast lesions and to determine the
sensitivity, specificity, positive predictive value, and negative predictive
value of radiological assessment. The findings are expected to improve
diagnostic accuracy, facilitate early detection of breast cancer, and
contribute locally relevant data to guide clinical practice and diagnostic
protocols, especially in resource-limited settings |