| CTRI Number |
CTRI/2026/01/100731 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A hospital-based study to screen young adults for early-onset colorectal cancer using stool tests and diet-lifestyle assessment |
|
Scientific Title of Study
|
A Hospital-Based Study on Early-onset colorectal cancer [EOCRC] screening using FIT test and dietary-lifestyle surveys in Central India |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhawna Sirohi |
| Designation |
Senior Consultant |
| Affiliation |
BALCO Medical Centre |
| Address |
Room No. 4,Medical Oncology OPD, Ground Floor, B Wing, Balco Medical Centre, Sector 36, Atal Nagar, PO Uparwara
Raipur CHHATTISGARH 493661 India |
| Phone |
9756999976 |
| Fax |
|
| Email |
bhawna.sirohi@vedanta.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Bhawna Sirohi |
| Designation |
Senior Consultant |
| Affiliation |
BALCO Medical Centre |
| Address |
Room No. 4,Medical Oncology OPD, Ground Floor, B Wing, Balco Medical Centre, Sector 36, Atal Nagar, PO Uparwara
Raipur CHHATTISGARH 493661 India |
| Phone |
9756999976 |
| Fax |
|
| Email |
bhawna.sirohi@vedanta.co.in |
|
Details of Contact Person Public Query
|
| Name |
Bhawna Sirohi |
| Designation |
Senior Consultant |
| Affiliation |
BALCO Medical Centre |
| Address |
Room No. 4,Medical Oncology OPD, Ground Floor, B Wing, Balco Medical Centre, Sector 36, Atal Nagar, PO Uparwara
Raipur CHHATTISGARH 493661 India |
| Phone |
9756999976 |
| Fax |
|
| Email |
bhawna.sirohi@vedanta.co.in |
|
|
Source of Monetary or Material Support
|
| BALCO Medical Center, Sector 36, Atal Nagar, PO Uparwara, Raipur, Chhattisgarh, India 493661
|
|
|
Primary Sponsor
|
| Name |
Vedanta Medical Research Foundation |
| Address |
Balco Medical Centre, Sector 36, Atal Nagar, PO Uparwara, Raipur, Chhattisgarh, India 493661
|
| 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 |
| Dr Bhawna Sirohi |
BALCO Medical Centre |
Room no 4, Medical Oncology,Ground floor, B wing, Sector 36, Atal Nagar, PO: Uparwara Raipur CHHATTISGARH |
9756999976
bhawna.sirohi@vedanta.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BMC-IRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
All participants who were newly registered and present with symptoms of early-onset colorectal cancer, and their first-degree relatives, will be included.
Participants above the age of 18 years and less than 50 years will be included
Participants who are willing to give a signed informed consent voluntarily
|
|
| ExclusionCriteria |
| Details |
Participants aged less than 18 years and More than 50 years
Participants who are already treated or under treatment for colorectal cancer
Participants with an inability to provide informed consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Early detection of early onset of colorectal cancer screening among symptomatic patients and their first-degree relatives in a tertiary care centre in Chhattisgarh |
February 2026 to July 2028 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="690" Sample Size from India="690"
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)
|
19/01/2026 |
| 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 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
|
The incidence of early-onset colorectal cancer (EOCRC) is increasing globally. A recent study from India showed that nearly one-third of new colorectal cancer cases occurred in young adults (<39 years), and a rising trend was observed in the incidence of lower gastrointestinal cancer cases. It is estimated that in the next 10 years, 25% of rectal cancers and 10–12% of CRC will be diagnosed in individuals younger than 50 years of age. In India, there has been an alarming rise in the incidence and deaths of EOCRC cases. EOCRC is particularly concerning due to younger patients being diagnosed at an advanced stage, aggressive nature and greater recurrence rates, all which leading to poor patient outcomes. There are many risk factors that lead to the development of early-onset colorectal cancer, including hereditary cancer syndromes, such as Lynch syndrome, obesity, diet, sedentary lifestyle, inflammatory bowel disease and altered microbiome. There were no established screening guidelines for colorectal cancer in India Therefore Early onset of colorectal cancers screening among symptomatic patients and their first degree relatives in a tertiary care centre in Chhattisgarh. A hospital-based prospective study will be conducted to assess the early onset of colorectal cancer among newly registered symptomatic young adults (<50 years) and their first degree relatives. |