| CTRI Number |
CTRI/2023/09/057370 [Registered on: 11/09/2023] Trial Registered Prospectively |
| Last Modified On: |
07/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalance of breast cancer |
|
Scientific Title of Study
|
Breast Cancer Screening for the students of Jashore University of science & Technology |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bonosree Rani Borsha |
| Designation |
Student |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room no:304,department of Physiotherapy And Rehabilitation,Dr.M R Khan medical center,Jashore University of Science And Tecnology,Jashore, Bangladesh
Not Applicable
N/A
7408
Other |
| Phone |
8801704401640 |
| Fax |
|
| Email |
b.biswasjust@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K M Amran Hossain |
| Designation |
Lecturer |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room no:304,department of Physiotherapy And Rehabilitation,Dr.M R Khan medical center,Jashore University of Science And Tecnology, Jashore, Bangladesh
Not Applicable
N/A
7408
Other |
| Phone |
8801735661492 |
| Fax |
|
| Email |
amranphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. K M Amran Hossain |
| Designation |
Lecturer |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room no:304,department of Physiotherapy And Rehabilitation,Dr.M R Khan medical center,Jashore University of Science And Tecnology, Jashore, Bangladesh
Not Applicable
N/A
7408
Other |
| Phone |
8801735661492 |
| Fax |
|
| Email |
amranphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy And Rehabilitation, Jashore University of Science And Tecnology |
|
|
Primary Sponsor
|
| Name |
Bonosree Rani Borsha |
| Address |
Department of Physiotherapy And Rehabilitation, Jashore University of Science And Tecnology |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sharmila jahan |
Dr. M R Khan Medical Center |
Room no:304,department of Physiotherapy And Rehabilitation,Dr.M R Khan medical center,Jashore University of Science And Tecnology,Jashore, Bangladesh
|
8801717362485
sharmilajahandu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jashore University of Science & Technology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening for Breast cancer |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1)Willing students of jasore University of Science and Technology, |
|
| ExclusionCriteria |
| Details |
1)Unwillingness to participate,age is beteween 18-30 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Risk of breast cancer screen through Breast Self-Examination |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="0"
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)
|
18/09/2023 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
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-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [b.biswasjust@gmail.com].
- For how long will this data be available start date provided 12-07-2023 and end date provided 12-07-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Aim: To assess breast self - examination practice and others risk factors, early detection of breast cancer ,evaluate the knowledge about breast carcinoma and breast related condition .Identifying the barrier in practicing. To find out the limitation in knowledge and practicing of BSE between students who carry out and not carry out. After completing trial registration ,the researcher will conducting with the students of Jashore University of Science and Technology who are willingly participate in the trial. |