| CTRI Number |
CTRI/2024/03/064737 [Registered on: 26/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Diagnostic
Preventive
Screening |
| Study Design |
Other |
|
Public Title of Study
|
clinicopathological correlation of fibroadenoma of breast |
|
Scientific Title of Study
|
A prospective comparative study of preoperative and postoperative clinicopathological correlation of fibroadenoma of 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 |
Ramala Sandeep Reddy |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
General Surgery Department, Jawaharlal Nehru Medical college, sawangi(meghe), wardha, pincode-442004, maharashtra.
Wardha
MAHARASHTRA
442004
India |
| Phone |
9441829555 |
| Fax |
|
| Email |
sandeepreddyramala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh R Chandak |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
General Surgery Department, Jawaharlal Nehru Medical college, sawangi(meghe), wardha, pincode-442004, maharashtra.
Wardha
MAHARASHTRA
442004
India |
| Phone |
9422143503 |
| Fax |
|
| Email |
srchandak63@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramala Sandeep Reddy |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
General Surgery Department, Jawaharlal Nehru Medical college, sawangi(meghe), wardha, pincode-442004, maharashtra.
Wardha
MAHARASHTRA
442004
India |
| Phone |
9441829555 |
| Fax |
|
| Email |
sandeepreddyramala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute Of Higher Education and Research,Sawangi, Meghe, Wardha, Maharashtra |
|
|
Primary Sponsor
|
| Name |
Ramala Sandeep Reddy |
| Address |
Laxmi pg boys hostel, room no-109, sawangi(meghe), wardha, maharashtra, pin code-442004 |
| 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 Sandeep Reddy |
Acharya Vinoba Bhave Rural Hospital |
General Surgery Department, Sawangi(Meghe), Wardha, Maharashtra, Pin code-442004
Wardha
MAHARASHTRA |
9441829555
sandeepreddyramala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS 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 |
LUMPECTOMY |
Frequency-1
Total duration-16-34 months |
| Comparator Agent |
Preoperatively Fine Needle Aspiration Cytology and post operatively Histopathology |
Frequency-1
Total duration-16-34 months |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
All patients admitted to Our Hospital with a provisional clinical diagnosis of Fibroadenoma and willing to give consent for the study
Premenopausal women |
|
| ExclusionCriteria |
| Details |
Patients with clinical diagnosis of breast lump other than fibroadenoma
FNAC findings other than fibroadenoma will be excluded
• previously operated breast |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensitivity and Specificity of Fine needle aspiration cytology. |
16-34 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| breast, local examination of breast, inspection and palpation of breast, examination of lymph nodes, blood investigations, F.N.A.C. preoperatively and histopathology postoperatively |
16-34 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
31/03/2024 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
After receiving the written informed consent from study participants to participate in the study and for publication of their data, patients who presented with a history of a breast lump were clinically, and F.N.A.C. was confirmed to have Fibroadenoma of the breast. Patients will be asked about their age, residence, social status, clinical history, past history, personal history, family history and will undergo physical examination of breast, local examination of breast, inspection and palpation of breast, examination of lymph nodes, blood investigations, F.N.A.C. preoperatively and histopathology postoperatively in that order. Frequency and percentage were used to express categorical data. The Chi-square test was used to analyze the relationship between variables. Mean and Standard Deviation were used to express quantitative data. For diagnosis, histopathological findings were linked with F.N.A.C. Calculations were made for the test’s sensitivity, specificity, positive predictive value, negative predictive value, and accuracy. Statistics were considered significant for P values under 0.05. |