| CTRI Number |
CTRI/2016/04/006865 [Registered on: 22/04/2016] Trial Registered Retrospectively |
| Last Modified On: |
09/09/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Breast cancer- early detection by self examination and clinical examination |
|
Scientific Title of Study
|
Early detection of breast cancer by self examination, clinical examination and fine needle aspiration cytology in rural women -a population based study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hilda Fernandes |
| Designation |
professor |
| Affiliation |
Fr Muller Medical College Mangalore |
| Address |
dept of pathology
Fr Muller Medical College
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9980017376 |
| Fax |
|
| Email |
hilda67@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Sanjeev Rai |
| Designation |
Chief of Medical Services |
| Affiliation |
Fr Muller Medical College |
| Address |
Fr Muller Medical College
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
08242238399 |
| Fax |
|
| Email |
raibs11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B Sanjeev Rai |
| Designation |
Chief of Medical Services |
| Affiliation |
Fr Muller Medical College |
| Address |
Fr Muller Medical College
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
08242238399 |
| Fax |
|
| Email |
raibs11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Ghandhi University of Health Sciences |
|
|
Primary Sponsor
|
| Name |
Rajeev Ghandhi University of Health Sciences |
| Address |
4TH T block
Jayanagar
Bangalore |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Fr Muller Medical College |
Kankanady
Mangalore |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Clement DSOUZA |
Fr Muller Medical college |
Surgery OPD no.32
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA |
9845237376
clement62@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Fr Muller institutional ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
women without breastcancer diagnoses |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
women above 20 years |
|
| ExclusionCriteria |
| Details |
Women who are already diagnosed with breast cancer
- Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
awareness of early signs of breast cancer
early detection of breast cancer |
ONE YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in mortality related to breast cancer |
many years |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
12/08/2013 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Breast cancer is now the commonest form cancer in women world over. The rise in its incidence is remarkably steep in developing countries. Breast cancer has emerged as the commonest cancer in urban Indian women and the second commonest among rural women. 1 Like the overall poor health awareness, awareness of breast cancer is poor among the masses. This along with a general indifference towards the health of women, a lac of breast cancer screening program and delay in seeking advice for a recognized health problem for financial and social reasons results in delayed diagnosis2,3. As a result, Indian breast cancer patients present with advanced disease and have numerous poor prognostic features such as large tumor, lymph node metastasis, high pathological grade and negative hormone receptors in many. 3. Majority of the multimodality treatment cancer centres are concentrated in the larger cities. Pathologist’ services like Fine Needle Aspiration Cytology are available mainly in the medical colleges. This along with lack of awareness of about their own breasts in rural women brings them to the doctor in an advanced stage.
In Fr Muller Medical College Hospital, all the breast lumps are subjected to FNAC. About 50 breast cancers are diagnosed annually with no false positive diagnosis and minimal false negative rate. However more than 100 breast cancers are studied in histopathology section. Surgeons from peripheral hospitals either send tru-cut or excision biopsies for diagnosis due to nonavailability of pathologists to do FNAC. Therefore there is an urgent need to create awareness about breast cancer and provide services of pathologists to rural areas.
.
|