| CTRI Number |
CTRI/2023/03/050553 [Registered on: 10/03/2023] Trial Registered Prospectively |
| Last Modified On: |
10/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessing treatment of patients in rural cancer centers |
|
Scientific Title of Study
|
Prospective observational study to assess the pattern of care of patients treated in rural cancer center |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravikant Singh |
| Designation |
Officer-in-charge and Medical Oncologist |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Center |
| Address |
Department of Medical Oncology,
Homi Bhabha Cancer Hospital and Research Center,
Uma Nagar,
Rasulpur Saidpur Bazid
Muzaffarpur
BIHAR
842001
India |
| Phone |
9110901500 |
| Fax |
|
| Email |
ravikant.tmh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravikant Singh |
| Designation |
Officer-in-charge and Medical Oncologist |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Center |
| Address |
Department of Medical Oncology,
Homi Bhabha Cancer Hospital and Research Center,
Uma Nagar,
Rasulpur Saidpur Bazid
Muzaffarpur
BIHAR
842001
India |
| Phone |
9110901500 |
| Fax |
|
| Email |
ravikant.tmh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravikant Singh |
| Designation |
Officer-in-charge and Medical Oncologist |
| Affiliation |
Homi Bhabha Cancer Hospital and Research Center |
| Address |
Department of Medical Oncology,
Homi Bhabha Cancer Hospital and Research Center,
Uma Nagar,
Rasulpur Saidpur Bazid
Muzaffarpur
BIHAR
842001
India |
| Phone |
9110901500 |
| Fax |
|
| Email |
ravikant.tmh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Homi Bhabha Cancer Hospital and Research Center,
Uma Nagar,
Rasulpur Saidpur Bazid,
Muzaffarpur,
Bihar 842001 |
|
|
Primary Sponsor
|
| Name |
Cancer Research and Statistic Foundation CRSF |
| Address |
Indravati River Park, Rawal Pada, SN Dube Road, Dahisar East, Mumbai-400068. |
| Type of Sponsor |
Other [Trust] |
|
|
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 Ravikant Singh |
Homi Bhabha Cancer Hospital & Research Center |
Medical Oncology OPD, Department of medical oncology, Uma Nagar, Rasulpur Saidpur Bazid
Muzaffarpur
BIHAR |
9110901500
ravikant.tmh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Krishna Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D487||Neoplasm of uncertain behavior ofother specified sites, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients treated in HBCH, Muzaffarpur from 1st February 2023 to 31st December 2025 will be selected for the study. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pattern of care in curative intent patients. Percentage of patients treated with surgery, definitive chemoradiation, systemic therapy and best supportive care
|
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pattern of care in palliative intent patients. Percentage of patients treated with surgery, definitive chemoradiation, systemic therapy and best supportive care |
3 years |
| Pattern of care in all patients. Percentage of patients treated with surgery, definitive chemoradiation, systemic therapy and best supportive care |
3 years |
| To asses factors (Age, Gender, Monthly income, Social support, ECOG PS , Stage and intent) impacting compliance to assigned therapy |
3 years |
| To estimate overall survival (Time from date of registration to date of death) and impact of different therapies on it as per intent and overall |
3 years |
|
|
Target Sample Size
|
Total Sample Size="7000"
Sample Size from India="7000"
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)
|
13/03/2023 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pattern of care studies provide real world estimate of treatment received by cancer patients. This data is not available for rural cancer centers. This is an important data which would provide data regarding compliance of therapy. This compliance may have an impact on overall survival. Hence this data would be required for comparison and future audits and comparison.
In this study we would evaluate the pattern of treatments received by cancer patients in HBCH Muzaffarpur cancer center. The idea is to see what proportion of patients take curative treatment , palliative treatment or no treatment. To study the impact of these treatments on overall survival.
|