CTRI Number |
CTRI/2018/11/016341 [Registered on: 15/11/2018] Trial Registered Prospectively |
Last Modified On: |
22/04/2022 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Single centre descriptive observational study |
Study Design |
Other |
Public Title of Study
|
Study to observe clinical and pathological presentation of breast lump in female of Bihar |
Scientific Title of Study
|
A clinical-pathological study of benign breast disease in tertiary centre of Bihar. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Mukesh kumar |
Designation |
Associate professor |
Affiliation |
igims patna |
Address |
Department of general surgery,Indira gandhi institute of medical sciences, Patna.
Patna BIHAR 800014 India |
Phone |
9708309952 |
Fax |
0612-2297225 |
Email |
drmukeshk@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Mukesh kumar |
Designation |
Associate professor |
Affiliation |
igims patna |
Address |
Department of general surgery, indira gandhi institute of medical sciences, patna.
Patna BIHAR 800014 India |
Phone |
9708309952 |
Fax |
0612-2297225 |
Email |
drmukeshk@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Mukesh kumar |
Designation |
Associate professor |
Affiliation |
igims patna |
Address |
Department of general surgery,indira gandhi institute of medical sciences, patna.
Patna BIHAR 800014 India |
Phone |
9708309952 |
Fax |
0612-2297225 |
Email |
drmukeshk@yahoo.com |
|
Source of Monetary or Material Support
|
Indira gandhi institute of medical sciences, patna |
|
Primary Sponsor
|
Name |
Dr mukesh kumar |
Address |
Department of general surgery, indira gandhi institute of medical sciences, patna |
Type of Sponsor |
Research institution |
|
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 mukesh kumar |
Room no. 425, 4th floor, ward block, Department of general surgery, |
Indira gandhi institute of medical sciences, patna.800014. Patna BIHAR |
9708309952 0612-2297225 drmukeshk@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethics comittee, igims, patna. |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: D249||Benign neoplasm of unspecified breast, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
15.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Female |
Details |
Female patients with benign disease of breast. for example breast lump, breast pain and nipple discharge. |
|
ExclusionCriteria |
Details |
Female patients with obvious malignant disease or those who had treated for malignancy. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Clinical presentation such as breast lump, breast pain and nipple discharge.also fnac report and birads grade from usg or mammography of breast. |
Clinical presentation such as breast lump, breast pain and nipple discharge.also fnac report and birads grade from usg or mammography of breast. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To check malignant changes in benign breast disease |
One year duration |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
19/11/2018 |
Date of Study Completion (India) |
15/02/2020 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
15/03/2020 |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
4. Khemka A, Chakravarti N, Shah S, Patel V. Palpable breast lumps: Fine needle aspiration cytology versus histopathology, a correlation of diagnostic accuracy. Internet J Surgery. 2009;18:1.
5. NavneetKaur, NitinAgarwal, Pankaj Parwar. Clinicopathological profile of benign breast conditions in Indian women. Prospective study based on aberrations of normal development and involution classification. World J Surgery. 2012; 36:2252-58.
6. A clinic-pathological study of benign breast disease in rural population. Das N et al. Int J Res Med Sci. 2014 Aug;2(3):1067-1069.
7. Study of various benign breast disease. SelvaKumran S et al. International surgery journal.2017 Jan;4(1):339-343.
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Benign breast disease is most common problem in females of our society. Benign breast disease is a group of breast disease which is not a cancer. Up to 30% of women suffer from benign breast disease will require treatment at some time in their lives. A tripple assessment which include clinical examination, immazing ( mammography or USG of breast) and pathological examination (FNAC or Core needle biopsy), during initial consultation, allows majority of the patients with discrete benign breast disease and to be given immediate reassurance. Making an early diagnosis and planning the treatment within 72 hour of the first consultation, helps in alleviating unnecessary anxiety about breast cancer. Breast self examination and education to females is very important in cases of benign breast disease. so Reassuarance is the first step in treatment of benign breast disease. This is observational descriptive study which will be done regarding clinical pathological pattern of benign breast disease of 100 females patients in General surgery OPD in IGIMS patna over one year duration.The aims and objective of this study are to find out different clinical presentation of benign breast disease and there incidence, to know age wise distribution of benign breast disease, side wise distribution and incidence of different types of benign breast disease. |