Clinical trial · Observational
The Implication of Plasma ctDNA Methylation Haplotypes in Detecting Colorectal Cancer and Adenomas
The Implication of Plasma Circulating Tumor DNA Methylation Haplotypes in Detecting Colorectal Cancer and Adenomas: a Multicenter, Cohort Study
NCT03737591CI-TRIAL-00056125completedClinicalTrials.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 is a multicenter, clinical study. This study is to evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting colorectal cancer, adenoma and the specificity in healthy individuals.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Next-generation sequencing (NGS) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Healthy individuals
- description
- Healthy individuals
- interventionNames
- Diagnostic Test: Next-generation sequencing (NGS)
- label
- Patients with Colorectal cancer
- description
- Stage I-IV colorectal cancer patients
- interventionNames
- Diagnostic Test: Next-generation sequencing (NGS)
- label
- Patients with Colorectal Adenomas
- description
- Patients with Colorectal Adenomas
- interventionNames
- Diagnostic Test: Next-generation sequencing (NGS)
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Healthy Individuals: * Written informed consent must be obtained from healthy individuals to comply with the requirements of the study. * Healthy individuals who received colonoscopy. Patients with Colorectal Cancer or Adenomas: * Male or female ≥ 18 years of age on the day of signing informed consent. * Patients need to receive surgical resection or endoscopic resection. * Patients must have histologically confirmed stage I-IV colorectal cancer or adenomas * Patients must have a performance status of ≤1 on the ECOG Performance Scale. * Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study. Exclusion Criteria: * Patients received adjuvant treatment prior to the surgical resection. * Patients received blood transfusion two weeks before or during the surgical resection. * Patients with unresected advanced colorectal adenoma. * Patients who are positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C. * Patients who are pregnant. * Patients who are alcoholic or drug abusers. * Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator.
References
Publications (1)
- DERIVEDMo S, Dai W, Wang H, Lan X, Ma C, Su Z, Xiang W, Han L, Luo W, Zhang L, Wang R, Zhang Y, Zhang W, Yang L, Lu R, Guo L, Zheng Y, Huang M, Xu Y, Liang L, Cai S, Cai G. Early detection and prognosis prediction for colorectal cancer by circulating tumour DNA methylation haplotypes: A multicentre cohort study. EClinicalMedicine. 2022 Nov 3;55:101717. doi: 10.1016/j.eclinm.2022.101717. eCollection 2023 Jan. PMID 36386039