Clinical trial · Observational
A Multi-center Trial to Establish a Model for the Early Diagnosis of Colorectal Cancer by the Detection of 5-hydroxymethylcytosine (5-hmC) in Plasma Cell-free DNA
A Multi-center, Prospective Trial of the Detection of 5-hydroxymethylcytosine (5-hmC) in Plasma Cell-free DNA for Establishing a Model for the Early Diagnosis of Colorectal Cancer
NCT03676075CI-TRIAL-00034935unknownClinicalTrials.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)
In this study, the investigators establish a model for the early diagnosis of colorectal cancer based on the detection of 5-hydroxymethylcytosine (5-hmC) in training group and validate the effectiveness of the model using a validation group recruited from multiple centers.
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 |
|---|---|---|---|
| Adenoma | Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma
- timeFrame
- 6 months
- description
- Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma in training group and validation group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Arm A * Histologically proven colorectal adenocarcinoma * No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri * Eastern cooperative oncology group score 0-2 * Informed consent Arm B * Histologically proven colorectal adenoma * No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri * Eastern cooperative oncology group score 0-2 * Informed consent Arm C * Healthy people with normal colonoscopy * No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri * Eastern cooperative oncology group score 0-2 * Informed consent Exclusion Criteria: Arm A * Patients received chemoradiotherapy or other anti-tumor therapy before being enrolled * Patients and/or family members can not understand and accept this study * Familial Adenomatosis Polyposis, Lynch Syndrome, acute inflammatory bowel disease * Pregnancy or lactation * Unsuitable to take part in the clinical trial judged by doctors Arm B * Patients received endoscopic resection before being enrolled * Patients and/or family members can not understand and accept this study * Familial Adenomatosis Polyposis, Lynch Syndrome, acute inflammatory bowel disease * Pregnancy or lactation * Unsuitable to take part in the clinical trial judged by doctors Arm C * Patients and/or family members can not understand and accept this study * Pregnancy or lactation * Unsuitable to take part in the clinical trial judged by doctors
References
Publications (0)
Data not yet available
No reference posted for this study.