| CTRI Number |
CTRI/2018/07/014963 [Registered on: 19/07/2018] Trial Registered Prospectively |
| Last Modified On: |
18/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Survival in colorectal patients in a tertiary care centre. |
|
Scientific Title of Study
|
A single centre retrospective study of survival, prognostic factors and treatment in colorectal cancer patients at tertiary care centre in India. |
| Trial Acronym |
CRCS01 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ranga Rao Rangaraju |
| Designation |
Director of Medical Oncology |
| Affiliation |
Max Super Speciality Hospital Shalimar Bagh |
| Address |
HOD room, Oncology daycare, lower basement, FC 50 CD Block Shalimar Bagh New Delhi
HOD room, Oncology daycare, lower basement, FC 50 CD Block Shalimar Bagh New Delhi
North
DELHI
110088
India |
| Phone |
|
| Fax |
|
| Email |
ranga.raorr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranga Rao Rangaraju |
| Designation |
Director of Medical Oncology |
| Affiliation |
Max Super Speciality Hospital Shalimar Bagh |
| Address |
FC 50 CD Block Shalimar Bagh New Delhi
FC 50 CD Block Shalimar Bagh New Delhi
DELHI
110088
India |
| Phone |
|
| Fax |
|
| Email |
ranga.raorr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rohit Singh Chauhan |
| Designation |
student |
| Affiliation |
Max Super Speciality Hospital Shalimar Bagh |
| Address |
Office of research, upper basement near parking, FC 50 CD Block Shalimar Bagh New Delhi
Office of research, upper basement near parking, FC 50 CD Block Shalimar Bagh New Delhi
North
DELHI
110088
India |
| Phone |
9910477591 |
| Fax |
|
| Email |
roitsinghchauhan118@gmail.com |
|
|
Source of Monetary or Material Support
|
| max healthcare pvt ltd
FC 50 C D BLOCK SHALIMAR BAGH 110088 |
|
|
Primary Sponsor
|
| Name |
max healthcare pvt ltd |
| Address |
FC 50 C D BLOCK SHALIMAR BAGH 110088 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| ROHIT SINGH CHAUHAN |
MAX SUPER SPECIALITY HOSPITAL |
FC 50 CD Block Shalimar Bagh New Delhi
North
DELHI |
9910477591
rohitsinghchauhan118l@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Max Healthcare Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
colorectal cancer patients, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Histologically proven colorectal carcinoma |
|
| ExclusionCriteria |
| Details |
Patient clinical data not available |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Estimation of overall survival (OS) rate and median overall survival of colorectal cancer treated patients |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Estimation of all treatment response in colorectal cancer patients.
2.Estimation of survival in different prognostic factor
Age group
Gender
Tumour location
Histological type
Tumour stage
Tumour differentiation grade
CEA level
K-RAS mutation
Lymph node status |
1 month |
|
|
Target Sample Size
|
Total Sample Size="95"
Sample Size from India="95"
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)
|
19/07/2018 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
After the completion of the study, under the discretion of the guide we intend to immediately publish the results in international and national journals. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
There is limited number of studies regarding the
prevalence, awareness in Indian subjects. So our study will add to the
available epidemiological data and also analyse the factors impacting the
survival of patents in Indian colorectal patients. |