| CTRI Number |
CTRI/2018/06/014464 [Registered on: 07/06/2018] Trial Registered Prospectively |
| Last Modified On: |
06/06/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
Survival among Breast Cancer Patients in Tertiary Hospital |
|
Scientific Title of Study
|
Clinical outcomes and its determinants among Breast Cancer Patients in a Tertiary Health Care
Hospital in South India
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr GUNASEELAN K |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Radiotherapy
Regional Cancer Center
JIPMER
Puducherry
Dhanvantri Nagar
Gorimedu
Puducherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9362966444 |
| Fax |
|
| Email |
gunapgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D KADAMBARI |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of General Surgery
JIPMER
Puducherry
Dhanvantri Nagar
Gorimedu
Puducherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9843323420 |
| Fax |
|
| Email |
kadambari1909@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GUNASEELAN K |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Radiotherapy
Regional Cancer Center
JIPMER
Puducherry
Dhanvantri Nagar
Gorimedu
Puducherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9362966444 |
| Fax |
|
| Email |
gunapgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Centre for Disease Informatics and Research
II Floor of Nirmal Bhawan, ICMR Complex,
Poojanhalli Road, Off NH-7,
Adjacent to Trumpet Flyover of BIAL
Kannamangala Post, Bangalore - 562 110
|
|
|
Primary Sponsor
|
| Name |
National Centre for Disease Informatics and Research |
| Address |
II Floor of Nirmal Bhawan, ICMR Complex,
Poojanhalli Road, Off NH-7,
Adjacent to Trumpet Flyover of BIAL
Kannamangala Post Bangalore - 562 110.
India. |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| National Centre for Disease Informatics and Research |
II Floor of Nirmal Bhawan, ICMR Complex,
Poojanhalli Road, Off NH-7,
Adjacent to Trumpet Flyover of BIAL
Kannamangala Post Bangalore - 562 110.
India. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr GUNASEELAN K |
Jawaharlal Institute of Postgraduate Medical Education and Research |
RT OPD No. 161, Regional Cancer Centre, JIPMER, Puducherry
Pondicherry
PONDICHERRY |
9362966444
gunapgi@gmail.com |
| Dr GUNASEELAN K |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Medical Oncology OPD and Ward
MO No. 12, Regional Cancer Centre, JIPMER, Puducherry
Pondicherry
PONDICHERRY |
9362966444
gunapgi@gmail.com |
| Dr GUNASEELAN K |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Surgery OPD and Ward
OPD No. 86, Old Black, 2nd Floor, JIPMER, Puducherry
Pondicherry
PONDICHERRY |
9362966444
gunapgi@gmail.com |
| Dr GUNASEELAN K |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Surgical Oncology OPD and Ward
OPD No. 211, Super Specialty Black (SSB), JIPMER, Puducherry
Pondicherry
PONDICHERRY |
9362966444
gunapgi@gmail.com |
| Dr GUNASEELAN K |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Pathology Record Section
Institute Black, 2nd Floor, JIPMER, Puducherry
Pondicherry
PONDICHERRY |
9362966444
gunapgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER Scientific Advisory Committee (JSAC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Breast Cancer Patients, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
98.00 Year(s) |
| Gender |
Both |
| Details |
All cases of malignant neoplasms of breast diagnosed microscopically or otherwise registered at our centre, irrespective of the method of treatment taken or planned (radical/palliative/no specific treatment) |
|
| ExclusionCriteria |
| Details |
Patients who cannot be persuaded to give consent for documentation at NCRP are not eligible for registration. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome of the study is pattern of care and survival in patients of carcinoma of breast would help in improving the care given to patients by effective planning and execution of cancer related programmes |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical outcomes and survival probability among the patients with Breast cancer. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="5000"
Sample Size from India="5000"
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)
|
09/05/2019 |
| 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="6"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Carcinoma
breast in the second most common malignancy among women in India. Breast cancer
is considered to be a systemic disease at diagnosis. Treatment is usually multimodal
and involves chemotherapy, surgery and radiation therapy. Radiation therapy and
surgery helps in achieving local control while chemotherapy takes care of micro
metastasis .The clinical course of breast cancer depends on several factors,
including socio-demographic pattern, the specific disease characteristics at
presentation, the biological features of the disease, and the treatment given.
Various studies have evaluated the pattern of breast cancer treatment outcome. This
study is intend to perform patter of care and survival study of patients with
breast cancer treated at our institute. There have been few studies analyzing
the disease pattern of breast cancer patients in India. This study will help to
find epidemiological survey, pattern of care and survival patterns of breast
cancer patients treated at our center in India. This project is seeks to
establish a comprehensive understanding of current patterns of care and best
practice models of the management and care with breast cancer to inform future
service improvement activities.
|