| CTRI Number |
CTRI/2025/02/080509 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Investigating the Role of Gut Bacteria in Colorectal Cancer Among Indian Patients |
|
Scientific Title of Study
|
Fecal Microbiome Analysis in Indian Colorectal Cancer Patients- An Exploratory Study |
| 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 Velukuru Sai Vivek |
| Designation |
Consultant-medical oncologist |
| Affiliation |
Aster CMI Hospital |
| Address |
Aster CMI Hospital
Medical oncology Department,
Room No.5,1st Floor,
No.43/2, NH 7, New Airport Road, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092
Bangalore
KARNATAKA
560092
India |
| Phone |
9916926532 |
| Fax |
- |
| Email |
velukuru.vivek@asterhospital.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Velukuru Sai Vivek |
| Designation |
Consultant-medical oncologist |
| Affiliation |
Aster CMI Hospital |
| Address |
Aster CMI Hospital
Medical oncology Department,
Room No.5, First Floor,
No.43/2, NH 7, New Airport Road, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092
KARNATAKA
560092
India |
| Phone |
9916926532 |
| Fax |
- |
| Email |
velukuru.vivek@asterhospital.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surinder Kher |
| Designation |
Head-Clinical Research Department |
| Affiliation |
Aster CMI Hospital |
| Address |
Aster CMI Hospital
Basement, Clinical Research Department, Opposite to IP Pharmacy,
No.43/2, NH 7, New Airport Road, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092
Bangalore
KARNATAKA
560092
India |
| Phone |
08043420940 |
| Fax |
- |
| Email |
research.aster@asterhospital.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aster CMI Hospital |
| Address |
No.43/2, NH 7, New Airport Road, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Velukuru Sai Vivek |
Aster CMI Hospital |
Aster CMI hospital
Basement, Clinical Research Department, opposite to IP Pharmacy,43/2, NH 7, New Airport Road, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092
Bangalore
KARNATAKA |
9916926532
-
velukuru.vivek@asterhospital.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aster CMI Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D898||Other specified disorders involving the immune mechanism, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Age above 18 at the time of informed consent.
2.Willing to give Informed consent
3.Confirmed diagnosis of CRC for which no treatment was initiated |
|
| ExclusionCriteria |
| Details |
1.unwilling to consent
2.usage of antibiotics, antivirals, anti parasitic agents in the last 3 months
3) usage of immunosuppressive medications – 3 months
4) Major surgery to the gastrointestinal tract in the previous 5 years
5) usage of probiotics greater than 1000000000 cfu per day in the last 6 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To analyse the prevalent gut microbiome in the Indian CRC patients and compare it to the data from the non CRC or healthy cohort
2) To observe the change in the microbiome post definitive anti-cancer treatment |
DNA sequencing of the gut microbiome at 2 time points. Baseline and 6 Months post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the change in the microbiome post definitive anticancer treatment |
Two time points
1. Baseline
2. 6 months post treatment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
03/03/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 colorectal cancer (CRC)in on the rise in countries which traditionally were thought to have lower rates, this includes India where the incidence is alarmingly getting higher with every decade. The focus on the association between gut microbiome and the development of CRC is evolving rapidly. The gut microbiome has an important role in the carcinogenesis by causing the initial inflammation and modulating different signalling pathways. In a dysbiotic state the response and resistance to systemic anti-cancer therapies is also governed by the gut microbiome. This establishes a prognostic and predictive value to the detection of pathogenic biomarkers in the stool and could also serve as good screening tool for early detection of CRC. The major hindrance to comprehensive understanding of the role of the microbiome in CRC biology is the lack of diversity of sample populations. Majority of the available data is from western stool samples. The limited Indian data available clearly shows a difference in the prevalence of carcinogenic bacteria hence making the western data irrelevant |