| CTRI Number |
CTRI/2025/03/082933 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
A community-based study comparing standard stool tests versus stool test with risk assessment for early colorectal cancer detection in younger adults |
|
Scientific Title of Study
|
A community-based 2-arm cluster randomized trial to compare universal FIT testing versus target (risk assessment done) FIT testing for Early onset colorectal cancer (EOCRC) in India |
| Trial Acronym |
PROSPECT-India |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhawna Sirohi |
| Designation |
Medical Director |
| Affiliation |
Vedanta Medical Research Foundation |
| Address |
Room No 4, Medical Oncology OPD, Ground floor, B wing, BALCO Medical Centre, Sector 36, Atal nagar, PO Uparwara, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
493661
India |
| Phone |
9756999976 |
| Fax |
|
| Email |
bhawna.sirohi@vedanta.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhawna Sirohi |
| Designation |
Medical Director |
| Affiliation |
Vedanta Medical Research Foundation |
| Address |
Room No 4, Medical Oncology OPD, Ground floor, B wing, BALCO Medical Centre, Sector 36, Atal nagar, PO Uparwara, Raipur, Chhattisgarh
CHHATTISGARH
493661
India |
| Phone |
9756999976 |
| Fax |
|
| Email |
bhawna.sirohi@vedanta.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhawna Sirohi |
| Designation |
Medical Director |
| Affiliation |
Vedanta Medical Research Foundation |
| Address |
Room No 4, Medical Oncology OPD, Ground floor, B wing, BALCO Medical Centre, Sector 36, Atal nagar, PO Uparwara, Raipur, Chhattisgarh
CHHATTISGARH
493661
India |
| Phone |
9756999976 |
| Fax |
|
| Email |
bhawna.sirohi@vedanta.co.in |
|
|
Source of Monetary or Material Support
|
| Cancer Research UK (CRUK) and National Cancer Institute (NCI) USA |
|
|
Primary Sponsor
|
| Name |
Vedanta Medical Research Foundation |
| Address |
Sector 36, Atal Nagar, P.O Uparwara, Nava Raipur, Chhattisgarh, 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 |
Vedanta Medical Research Foundation (BALCO Medical Centre) |
Department of Medical Oncology, Ground Floor, B wing,Room no 1, Sector 36, Atal Nagar, PO Uparwara, Nava Raipur, Raipur, Chhattisgarh
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 |
| Healthy Human Volunteers |
Screening intervention of early onsent of Colorectal Cancer |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fecal Immunochemal Test (FIT)- Target |
Participants in this group will undergo a colorectal-specific risk assessment (dietary and lifestyle) followed by a fecal immunochemical test (FIT Test). |
| Comparator Agent |
Fecal Immunochemical Test (FIT)-General |
Participants in this group will undergo only the FIT Test without any risk assessment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Healthy Participants above 18 years of age.
Participants who are willing to volunatrily give informed consent.
Participants who are residents of Chhattisgarh and kerala. |
|
| ExclusionCriteria |
| Details |
Participants who are less than 18 years.
Participants with a diagnosis or past history of colorectal cancer.
Patients actively being treated for colorectal cancer.
Participants with an inability to provide informed consent. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We will assess the hypothesis that implementing a risk assessment tool, followed by communicating the identified risk, will increase the proportion of individuals in the camp who return a FIT test (FIT-target), compared to those in the camp where individuals are offered a FIT test without risk assessment or communication of risk (FIT-general). |
156 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| We will evaluate the hypothesis that the screening camp where individuals are identified as high-risk by the risk assessment tool will also have a higher likelihood of having an adenoma and CRC, among those aged more than 50 years |
156 Weeks |
|
|
Target Sample Size
|
Total Sample Size="4200"
Sample Size from India="4200"
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)
|
02/06/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Although
traditionally regarded as a low-incidence region, India has experienced a rapid rise in EOCRC
incidence in the last few years. The Delhi State Cancer Institute recently reported
that an astonishing 60% of their CRC patients were aged <50 years, with younger patients more often diagnosed at
an advanced stage. In 2019 data from
a separate center, the mean age of diagnosis among 970 CRC patients was 47.5 years, with 35% of newly diagnosed CRC
patients being under the age of 40.1 This trend reflects
global trends with most low- and middle-income countries experiencing a dramatic rise
in EOCRC, mimicking
that which began over a decade prior in high-income countries. Currently, there are no population-level screening guidelines for CRC in India,
and it is unclear if data around efficacy and optimal
screening age derived from Western countries can be extrapolated to India. Thus, the present juncture is an
opportune time to initiate community- based trials in India to not only measure
the rapid acceleration CRC incidence, but also identify effective strategies for intervention, including assessing
the impact of population-based CRC
screening.
|