Use of Plasma ctDNA Methylation Haplotypes in Detecting Local Residual or Lymph Node Metastasis

• Conditions: Colorectal Cancer; Lymph Node Metastases
• Interventions: Diagnostic Test: Next-generation sequencing (NGS)

• Registration Number: NCT03868215
• Lead Sponsor: Fudan University

Brief Summary

This is a prospective, clinical study. This study is to evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting local residual or lymph node metastasis.

Detailed Description

Colorectal cancer (CRC) is the third most common cancer worldwide, the second deadliest cancer in the United States. DNA methylation is a commonly used biomarker for non-invasive CRC detection in plasma. The low sensitivity of blood-based tests is due to several limitations of detecting ctDNA in early-stage cancer. We developed and validated a high-throughput methylation-based blood test highly sensitive for colorectal cancer and precancerous lesions. This previously established colorectal tumor-specific plasma ctDNA methylation markers (diagnostic model established by next-generation sequencing of 2181 gene loci methylation) had a high sensitivity in CRC patients and a high specificity in healthy individuals in a large retrospective sample study. This prospective, clinical study is to further evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting local residual or lymph node metastasis.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2018-11-09
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-07
• Last Update Submitted: 2019-03-07
• Study First Posted: 2019-03-11
• Last Update Posted: 2019-03-11
• Primary Completion: 2019-08-31
• Study Completion: 2020-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with endoscopically removed malignant polyps.
• Male or female ≥ 18 years of age on the day of signing informed consent.
• Patients who received surgical resection following removal of malignant polyps by colonoscopy.
• 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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with endoscopically removed malignant polyps	Next-generation sequencing (NGS)	Patients with endoscopically removed malignant polyps

Primary Outcome Measures

Name	Time	Method
Sensitivity	2 years	The sensitivity of plasma ctDNA methylation haplotypes in detecting local residual or lymph node metastasis

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China