Clinical trial · Observational
Fecal DNA Methylation Test for Colorectal Cancer Screening
A Fecal DNA Methylation Test for Colorectal Cancer Screening Using Multitarget Real-Time PCR Method-A Observational, Prospective Study
- 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 is an observational, prospective study using fecal DNA methylation test to define the risk of suffering from advanced adenoma or colorectal cancer (CRC) compared to colonoscopy and fecal immunochemical test (FIT). This study recruits at least 80 participants, including 40 people of healthy controls, 20 people with adenoma, and 20 people with CRC, which were confirmed by colonoscopy. All fecal specimens from participants will be examined by FIT and multi-methylated target gene detection through real-time quantitative methylation-specific PCR (qMSP). The objective of this study is to evaluate the sensitivity and specificity of multi-methylated target PCR compared with the FIT and confirm the examination results through colonoscopy.
Conditions
Conditions (2)
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 Adenoma | Colorectal Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stool DNA methylation detection | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Healthy group : Stool specimens from participants with healthy colon
- description
- Stool specimens will be collected from participants before having a colonoscopy. If the participant's colon has a healthy colon without any cancerous lesion, the stool specimen will be included in the healthy group.
- interventionNames
- Diagnostic Test: Stool DNA methylation detection
- label
- Disease group : Stool specimens from participants with adenoma/colorectal cancer
- description
- Stool specimens will be collected from participants before having a colonoscopy. If the participant's colon has precancerous lesion, such as adenoma, the stool specimen will be included in the disease group. Also, specimens from confirmed colorectal cancer patients are included in the disease group.
- interventionNames
- Diagnostic Test: Stool DNA methylation detection
Primary outcomes (1)
- measure
- Sensitivity and specificity of methylation biomarker and FIT for adenoma and colorectal cancer screening
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with age over 40 but under 80, who need to take colonoscopy or diagnostic confirmed colorectal cancer patient. Exclusion Criteria: * Participants who are undergoing cancer treatments or have diagnosed with cancer, received cancer treatment in the past. * Participants who have received any cancer treatments, including chemotherapy and radiotherapy before taking surgery. * Participants have received any surgery for colorectal cancer in the past. * Pregnant women or nursing women.
References
Publications (0)
Data not yet available