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Catch the cancer; towards a cfDNA-based test for colorectal cancer screening

Catch the cancer; towards a cfDNA-based test for colorectal cancer screening - CATCA-study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48193
Enrollment
150
Registered
2019-05-14
Start date
2019-06-01
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

colorectal cancer colorectal carcinoma

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Individuals participating in the Dutch national colorectal cancer screening program who: - Have a positive FIT (fecal immunohistochemical test), prior to sequential colonoscopy (performed in the Erasmus MC); - Grant informed consent to participate in this study;;Lynch Syndrome carriers under surveillance of gastroenterologists in the Erasmus MC, who: - Have proven Lynch syndrome (DNA mismatch repair mutation); - Are >=18 years; - Grant informed consent to participate in this study.

Exclusion criteria

Exclusion criteria: Individuals participating in the Dutch national colorectal cancer screening program who: - Are known to be carrier of a genetic predisposition for colorectal cancer (for example Familial Adenomatous Polyposis or MUTYH Associated Polyposis); - Have a negative FIT; - Have a positive FIT with sequential colonoscopy already performed; - Are unwilling to undergo colonoscopy or receive unexpected, but relevant and actionable findings; - Underwent a failed colonoscopy;;Lynch Syndrome carriers who: - Are unwilling to undergo colonoscopy or receive unexpected, but relevant and actionable findings; - are

Design outcomes

Primary

MeasureTime frame
The agreement between cfDNA profiles and DNA profiles of corresponding lesions found during regular colonoscopy.

Secondary

MeasureTime frame
The extent of psychological burden caused by this screening tool.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)