Clinical trial · Observational
Performance Evaluation of the Micromedic CD24 in Vitro Diagnostic Assay
Performance Evaluation of the Micromedic CD24 Western Blot and ELISA in Vitro Diagnostic Assay
NCT01214512CI-TRIAL-00009697completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is aimed to evaluate the performance of the Micromedic CD24 assay in identifying colorectal adenoma using Western blot and ELISA assays. These assays are designed to detect CD24 protein in peripheral blood leukocytes (PBL). Elevated levels of CD24 may be indicative of colorectal adenoma (inclusive of optically detectable early adenoma to late adenoma, and cancer).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood-sample based diagnostic assay | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Colonoscopy and CD24 assay correlation
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Subject is 50 years old and above * Subject is asymptomatic and referred for regular recommended screening colonoscopy or subject is referred due to suspicion of colon cancer, prior to beginning of any treatment (enriched population) * Subject signed the informed consent Exclusion Criteria: * Subject has been previously diagnosed with any type of cancer * Subject has been previously diagnosed with a colorectal abnormality such as colorectal adenoma, hyperplastic polyp or carcinoma * Blood sample was not collected on the day of colonoscopy and prior to colonoscopy * Subject has first degree family history of colorectal cancer * Subject has active infection or inflammation as determined clinically at screening * Subject is currently taking medications related to the previous exclusion criteria * Subject has participated in, or is participating in, any investigational drug or device study within 30 days prior the date of colonoscopy and any additional study required test * Pregnant or lactating woman
References
Publications (0)
Data not yet available
No reference posted for this study.