Clinical trial · Observational
Exploratory Study of a Novel Based rbcDNA Liquid Biopsy Technique for Colorectal Cancer Early Detection
NCT05875584CI-TRIAL-00080222completedClinicalTrials.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)
Exploration of a novel rbcDNA liquid biopsy technique for early detection of colorectal cancer is a promising development in the field of disease diagnosis and screening. This technique has the potential to establish an efficient and sensitive system for the early detection of colorectal cancer, which can provide a new perspective for individual health monitoring.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoma | Adenoma | ONTOLOGY_EXACT | 0.98 |
| Adenomatous Polyps | Adenomatous Polyp | ALIAS | 0.90 |
| Advanced Adenoma | Adenoma | CURATED_BROADER | 0.78 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rbcDNA test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- advanced adenomas (AA) group
- description
- Prospective enrollment of subjects with advanced adenomas
- interventionNames
- Diagnostic Test: rbcDNA test
- label
- CRC group
- description
- Retrospective enrollment of subjects with confirmed colorectal cancer
- interventionNames
- Diagnostic Test: rbcDNA test
Primary outcomes (1)
- measure
- Evaluating the sensitivity, specificity, and accuracy of rbcDNA in colorectal cancer screening
- timeFrame
- Through study completion，an average of 1 year
- description
- A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The rbcDNA test was deployed to a composite score. The tests were processed independently of colonoscopy procedure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age:40-74Years 2. Sex:All 3. Willing to provide written consent 4. Plan to undergo colorectaloscopy or surgical treatment and be able to provide a complete medical history and cooperate with blood sampling and follow-up visits，other operation. For advanced adenomas (AA) group: 1. Adenomatous polyps with ≥25% villous component, high-grade dysplasia (HGD), or a diameter ≥10 mm were considered AA. Sessile serrated lesions with diameters ≥10 mm. 2. treatment-naive 3. No other comorbid tumors For CRC group: 1. Confirmed CRC patients 2. treatment-naive 3. No other comorbid tumors Exclusion Criteria: 1. Patients with colorectal cancer who have received prior treatment. 2. FAP (familial adenomatous polyposis), Crohn's disease, ulcerative colitis 3. Participants taking anticoagulants such as aspirin or warfarin, or those with coagulation disorders. 4. Prior history of colonoscopy within the past 5 years and removal of lesions 5. Pregnancy or intestinal infarction people 6. Unable to provide informed consent 7. Participants in other clinical trials or who have participated in other clinical trials within 60 days. 8. Unable to provide stool sample and follow-up visits. 9. Presence of major infectious diseases (e.g. HIV, etc.)
References
Publications (0)
Data not yet available
No reference posted for this study.