| CTRI Number |
CTRI/2026/04/108983 [Registered on: 21/04/2026] Trial Registered Prospectively |
| Last Modified On: |
18/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical and pathological evaluation of breast lumps in females less than 40 years of age. |
|
Scientific Title of Study
|
Clinico-pathological study of breast lump in females upto 40 years of age |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anmolpreet Singh |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru Ramdas University of Health Sciences and research |
| Address |
Vpo ladhai ke
tehsil bagha purana
district moga
Moga
PUNJAB
142038
India |
| Phone |
9814001435 |
| Fax |
|
| Email |
anmolpreetbrar97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MANJIT SINGH UPPAL |
| Designation |
Professor |
| Affiliation |
Sri Guru Ramdas University of Health Sciences |
| Address |
Sri Guru Ramdas University of Health Sciences And research, amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
9815088007 |
| Fax |
|
| Email |
vicechancellor@sgrduhs.in |
|
Details of Contact Person
Public Query
|
| Name |
Anmolpreet Singh |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru Ramdas University of Health Sciences and research |
| Address |
Vpo ladhai ke
tehsil bagha purana
district moga
Moga
PUNJAB
142038
India |
| Phone |
9814001435 |
| Fax |
|
| Email |
anmolpreetbrar97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Guru Ramdas institute of medical sciences and research vallah Amritsar Punjab India 143501 |
|
|
Primary Sponsor
|
| Name |
Department of surgery in Sri guru ram das university of health sciences and research |
| Address |
Sri guru ram das university of health sciences and research amritsar punjab India 143501 |
| Type of Sponsor |
Private medical college |
|
|
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 Anmolpreet Singh |
Sri Guru Ramdas institute of medical sciences and research valla ,Amritsar |
Department of surgery
Surgery unit 1 second floor in ward
Amritsar
PUNJAB |
9814001435
anmolpreetbrar97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTINAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
FEMALE PATIENTS AGED TILL 40 YEARS OF AGE PRESENTING WITH PALPABLE BREAST LUMP
PATIENTS WHO GIVE INFORMED WRITTEN CONSENT FOR PARTICIPATION IN THE STUDY .
PATIENCE WILLING TO UNDERGO COMPLETE CLINICAL EXAMINATION , IMAGING AND BIOPSY IF REQUIRED . |
|
| ExclusionCriteria |
| Details |
FEMALE PATIENTS ABOVE 40 YEARS OF AGE.
FEMALE PATIENTS WITH BREAST ABSCESS .
FEMALE PATIENTS WITH LUMP WITH OVERLYING SKIN CHANGES . |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| MAJORITY OF BREAST LUMP IN FEMALES UPTO 40 YEARS OF AGE ARE BENIGN IN NATURE |
Initial clinical presentation of the patients with breast lumps and histopathological evidence of the disease after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/04/2026 |
| 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="1"
Months="6"
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 lump is a common complaint among females under 40 years of age, with most cases being benign. This study evaluates the clinical features, radiological findings, and histopathological patterns of breast lumps in this age group. Patients are assessed through clinical examination, imaging, and cytological or histopathological investigations to establish an accurate diagnosis. The study helps in identifying the spectrum of breast diseases, where benign conditions like fibroadenoma are most common, while breast cancer occurs less frequently. Early clinicopathological correlation is essential for proper diagnosis and management.
|