| CTRI Number |
CTRI/2021/04/032519 [Registered on: 05/04/2021] Trial Registered Prospectively |
| Last Modified On: |
05/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Application of Asia Pacific colorectal screening score to identify high risk population for colorectal cancer in health check-up participants. |
|
Scientific Title of Study
|
Application of Asia Pacific colorectal screening score to identify high risk population for colorectal cancer in health check-up participants |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devendra Desai |
| Designation |
Consultant Gastroenterologist |
| Affiliation |
P. D. Hinduja Hospital and Medical Research Centre, Mahim |
| Address |
Room no 1106, OPD building, department of Gastroenterology, P. D. Hinduja Hospital and Medical Research Centre, Veer Savarkar Marg, Mahim, Mumbai-400 016 India.
Mumbai
MAHARASHTRA
400016
India |
| Phone |
9322596152 |
| Fax |
|
| Email |
dr_ddesai@hindujahospital.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devendra Desai |
| Designation |
Consultant Gastroenterologist |
| Affiliation |
P. D. Hinduja Hospital and Medical Research Centre, Mahim |
| Address |
Room no 1106, OPD building, department of Gastroenterology, P. D. Hinduja Hospital and Medical Research Centre, Veer Savarkar Marg, Mahim, Mumbai-400 016 India.
MAHARASHTRA
400016
India |
| Phone |
9322596152 |
| Fax |
|
| Email |
dr_ddesai@hindujahospital.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikhil Bhangale |
| Designation |
Resident in DNB gastroenterology |
| Affiliation |
P. D. Hinduja Hospital and Medical Research Centre, Mahim |
| Address |
1302, Solitaire, bhagoji keer road, off senapati bapat marg, mahim west, 400016, Mumbai
Mumbai
MAHARASHTRA
400016
India |
| Phone |
8822882345 |
| Fax |
|
| Email |
nikhilb.ebox@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
P D Hinduja Hospital and Medical Research Centre |
| Address |
P. D. Hinduja Hospital and Medical Research Centre Veer Savarkar Marg Mahim Mumbai-400 016 India |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Devendra Desai |
P. D. Hinduja Hospital and Medical Research Centre |
1106, Department of Gastroenterology, P. D. Hinduja Hospital and Medical Research Centre, Veer Savarkar Marg, Mahim, Mumbai-400 016 India
Mumbai
MAHARASHTRA |
9322596152
dr_ddesai@hindujahospital.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB Committee, P. D. Hinduja Hospital and Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants more than 45 years of age coming to health checkup facility |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All participants more than 45 years of age coming to health checkup facility |
|
| ExclusionCriteria |
| Details |
1. <45 years of age
2. history of any colorectal neoplasm (benign or malignant)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study what proportion of health check-up population are high risk for development of CRC as per Asia Pacific colorectal screening score |
At baseline only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess awareness about colorectal cancer screening |
At baseline only |
| To assess willingness about colorectal cancer screening |
At baseline only |
|
|
Target Sample Size
|
Total Sample Size="195"
Sample Size from India="195"
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)
|
05/04/2021 |
| 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="3"
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)?
Response - NO
|
|
Brief Summary
|
Colorectal carcinoma (CRC) is one of the most common cause of cancer and 2nd most common leading cause of cancer-related death in both men & women in United States. CRC develops through series of events from dysplasia to frank carcinoma slowly over few years. Various screening tools help in early detection of CRC or the changes leading to CRC which can be tackled appropriately thereby reducing CRC-related mortality. In Asians, there are no guidelines for screening for CRC. Attempts have been made to identify high risk population who may benefit by screening. It is not known how many Indian people would fit in these criteria. Thus, this study aims to identify proportion of high-risk population for developing CRC in Indian population. It is also not known as to how many people will consider undergoing CRC screening. So, this study has secondary outcome to assess awareness, willingness and various reasons for unwillingness. |