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Clinical sensitivity and specificity evaluation of blood mRNA-based in vitro diagnostic medical device 'ONCOCHECKTM Colorectal Cancerr' for Colorectal Cancer diagnosis

Clinical evaluation of the sensitivity and specificity of the 'ONCOCHECKTM Colorectal Cancer' screening kit using human whole blood and comparative assessment with the standard diagnostic criteria for colorectal cancer, such as endoscopy and tissue biopsy results, single-blind confirmatory clinical performance study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0009838
Enrollment
502
Registered
2024-10-11
Start date
2024-04-25
Completion date
Unknown
Last updated
2024-11-14

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

Conditions

None listed

Interventions

None listed

Sponsors

Yonsei University Health System, Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Gender: Male, Female Age: 45 years over (1) Individuals who have been adequately informed about the clinical trial and have voluntarily consented to participate (2) Individuals who can provide a blood sample within three month before or after a colonoscopy procedure (3) Adults aged 45 or above. (4) Samples from patients diagnosed with colorectal cancer who have not received cancer treatments such as surgery, chemotherapy, or radiation therapy. (5) Samples from individuals with confirmed advanced adenoma or serrated polyp presence. (6) Samples from individuals who do not have colorectal cancer, advanced adenoma, or serrated polyp (7) Samples from individuals diagnosed with cancers other than colorectal cancer.

Exclusion criteria

Exclusion criteria: (1) Vulnerable participants with intellectual disabilities or severe mental disorders will be excluded. (2) Individuals deemed unsuitable by the researchers' judgment will be excluded. (3) Samples with a history of receiving medication or treatment affecting immune function within the last 6 months will be excluded.

Design outcomes

Primary

MeasureTime frame
Evaluation of the effectiveness of the 'ONCOCHECKTM Colorectal Cancer’ through clinical sensitivity and specificity assessment

Secondary

MeasureTime frame
Evaluation of correlation (consistency) with colonoscopy and biopsy results, which are standard criteria for colon cancer diagnosis

Countries

Korea, Republic of

Contacts

Public ContactYihwa Bae

Yonsei University Health System, Severance Hospital

v2_en99@yuhs.ac+82-2-2228-0526

Outcome results

None listed

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