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A community-based study comparing standard stool tests versus stool test with risk assessment for early colorectal cancer detection in younger adults

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 - PROSPECT-India

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/082933
Enrollment
4200
Registered
2025-03-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Sponsors

Vedanta Medical Research Foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy Participants above 18 years of age. Participants who are willing to volunatrily give informed consent. Participants who are residents of Chhattisgarh and kerala.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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).Timepoint: 156 weeks

Secondary

MeasureTime frame
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 yearsTimepoint: 156 Weeks

Countries

India

Contacts

Public ContactDr Bhawna Sirohi

Vedanta Medical Research Foundation

bhawna.sirohi@vedanta.co.in9756999976

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026