| CTRI Number |
CTRI/2011/07/001872 [Registered on: 08/07/2011] Trial Registered Retrospectively |
| Last Modified On: |
08/07/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A study to identify the risk factors of Breast Cancer among Indian Women |
|
Scientific Title of Study
|
"Relevance of ’Risk Factors’ of Breast Cancer among Indian women: An Indian scenario" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ranen Kanti Aich |
| Designation |
Associate Professor |
| Affiliation |
Dept. of Radiotherapy, N. R. S. Medical College, Kolkata - 700014. |
| Address |
Simultala, Agarpara, North 24 parganas,
138 A J C Bose Road, PIN:700014, Kolkata,West Bengal.
Kolkata
WEST BENGAL
700109
India |
| Phone |
9830341692 |
| Fax |
|
| Email |
ranenaich@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranen Kanti Aich |
| Designation |
Associate Professor |
| Affiliation |
Associate Professor, Dept. of Radiotherapy, NRS Med. College, Kolkata - 700014 |
| Address |
Simultala, Agarpara, North 24 parganas,
North 24 Parganas
Kolkata
WEST BENGAL
700109
India |
| Phone |
9830341692 |
| Fax |
|
| Email |
ranenaich@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranen Kanti Aich |
| Designation |
|
| Affiliation |
|
| Address |
Simultala, Agarpara, North 24 parganas,
North 24 Parganas
Kolkata
WEST BENGAL
700109
India |
| Phone |
9830341692 |
| Fax |
|
| Email |
ranenaich@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
|
| Type of Sponsor |
|
|
|
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 Ranen Kanti Aich |
Dept. of Radiotherapy. |
N. R. S. Medical College, Kolkata, PIN:700014,
Kolkata
WEST BENGAL |
9830341692
ranenaich@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, NRS Medical College, Kolkata-700014 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Data are being collected from consenting women suffering from breast cancer irrespective of age or stage of the disease regarding the presence of risk factors of breast cancer. , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
|
| Comparator Agent |
Nil |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
81.00 Year(s) |
| Gender |
Female |
| Details |
Study population: Existence of risk factors were assessed in women suffering from breast cancer irrespective of age, socio-economic status or stage of the disease.
Control population:Same risk factors were assessed in age matched women not suffering from breast cancer. |
|
| ExclusionCriteria |
| Details |
Non consenting women, Psychologically challenge women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of relevance of the so called Risk Factors of Breast Cancer among women of Indian origin. |
From 01.01.2008 to 01.12. 2010 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="1200"
Sample Size from India="1200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2008 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Incidence of breast cancer is rising in India. From long clinical experience, it appears that the ’so-called’risk factors of breast cancer e.g. Nulliparity, Early menarche,Late menopause, etc as reported in various studies conducted among among women of Western countries are not applicable to women of our country. Some other factors may prevail. Aim of this study is to find out the relevance of the reported risk factors and to identify any other risk factor, if present.From preliminary analysis it seems that classical risk factors for breast cancer as described in the western literature are not applicable in the Indian population of breast cancer patients.
|