| CTRI Number |
CTRI/2024/07/071650 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Listing of all cancer patients at Balco Medical Centre. |
|
Scientific Title of Study
|
Hospital Based Cancer Registry |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Bhawna Sirohi |
| Designation |
Senior Consultant |
| Affiliation |
BALCO medical Center |
| Address |
Room No. 4,Medical Oncology OPD, Ground Floor, B Wing,
Balco Medical Centre,
Sector 36, Atal Nagar, PO Uparwara, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
493661
India |
| Phone |
9756999976 |
| Fax |
|
| Email |
bhawna.sirohi@vedanta.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Bhawna Sirohi |
| Designation |
Senior Consultant |
| Affiliation |
BALCO medical Center |
| Address |
Room No. 4,Medical Oncology OPD, Ground Floor, B Wing,
Balco Medical Centre,
Sector 36, Atal Nagar, PO Uparwara, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
493661
India |
| Phone |
9756999976 |
| Fax |
|
| Email |
bhawna.sirohi@vedanta.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Bhawna Sirohi |
| Designation |
Senior Consultant |
| Affiliation |
BALCO medical Center |
| Address |
Room No. 4,Medical Oncology OPD, Ground Floor, B Wing,
Balco Medical Centre,
Sector 36, Atal Nagar, PO Uparwara, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
493661
India |
| Phone |
9756999976 |
| Fax |
|
| Email |
bhawna.sirohi@vedanta.co.in |
|
|
Source of Monetary or Material Support
|
| ICMR-NCDIR, II Floor of Nirmal Bhawan, ICMR Complex
Poojanhalli Road, Off NH-7,
Adjacent to Trumpet Flyover of KIAL
Kannamangala Post Bengaluru - 562 110.
India. |
|
|
Primary Sponsor
|
| Name |
ICMR-NCDIR |
| Address |
II Floor of Nirmal Bhawan, ICMR Complex
Poojanhalli Road, Off NH-7,
Adjacent to Trumpet Flyover of KIAL
Kannamangala Post Bengaluru - 562 110.
India. |
| Type of Sponsor |
Research institution |
|
|
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 Bhawna Sirohi |
BALCO Medical Centre |
Room no 4, Medical Oncology, Sector 36, Atal Nagar, PO: Uparwara, Raipur, Chhattisgarh 493661
Raigarh
CHHATTISGARH |
9756999976
bhawna.sirohi@vedanta.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BALCO Medical Centre- Institutional Review Board (BMC-IRB) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. All Neoplasms with a behavior code of 3 as defined by the International Classification of Diseases for Oncology 3rd edition will be recruited.
2. Cancer from all sites with a confirmatory diagnosis
3. Participants of all age groups will be recruited |
|
| ExclusionCriteria |
| Details |
1. Any neoplasm with a behavior code of <3 will be excluded.
2. Borderline Malignancy, Carcinoma In-situ will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To describe the profile and patterns of cancer in patients availing of care at the reporting hospital.
2. To contribute data on cancer patients to the respective PBCRs in India under ICMR- NCDIR-NCRP.
|
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Screen eligible patients & abstract medical records to describe the diagnostic, staging, & treatment details of the cancer patients. |
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="200000"
Sample Size from India="200000"
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)
|
10/08/2024 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
In 2020, there were an estimated 1.39 million cancers in India. Cancer
surveillance is an essential part of cancer prevention and control efforts.
The specific objectives of this project include describing the cancer types clinical, pathological, and treatment-related details
and outcomes among cancer
patients availing of care. Data on cancer patients will be collected from all the cancer diagnosing and treating departments at a hospital, using
a standardized core form. A specially
designed software will be used for data quality checks and data transmission to
NCDIR, for further analysis and
dissemination. The findings from hospital based registry will help to assess the patterns and quality of cancer care at
specific hospitals, and reflect on the health system performance on cancer related diagnosis and treatment. It will
also help in the planning of health services,
resource allocation and evaluation of cancer care
services. |