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

• Conditions: Adenoma; Colorectal Cancer

• Registration Number: NCT03676075
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

According to precious studies, 5-methylcytosine (5-mC) and 5-hydroxymethylcytosine (5-hmC) are both important epigenetic markers whose changes are associated with many kinds of diseases, including cancers. This changes may help diagnose cancer. The new detection method for 5-hmC can meet the requirements of liquid biopsy.

The traditional diagnostic methods for colorectal cancer is colonoscopy and pathology which are inconvenient and unpleasant, and sometimes, it is difficult for the very patients to get tissues or get enough tissues to confirm the pathologic diagnosis. In addition, other screening methods for colorectal cancer,such as guaiac-based fecal occult blood testing and a blood test for methylated SEPT9 DNA, have the shortcomings of relatively low sensitivity and specificity. As a result, it is imperative to find a new detection method for early diagnosis of colorectal cancer with the advantages of high sensitivity and specificity, minimally invasive and convenient.

The aim of this multi-center research is to establish a model for the early diagnosis of colorectal cancer by the detection of 5-hmC in plasma cell-free DNA. Patients who are diagnosed with colorectal cancer by colonoscopy and pathology and not received any anti-tumor therapy (Arm A) will be eligible for inclusion. In addition, patients who suffer with adenoma and not received endoscopic resection (Arm B) will be eligible as well as healthy individuals with normal colonoscopy (Arm C). Then, 5-hmC in plasma cell-free DNA will be detected and compared among the three arms of patients (training group) to establish a model to diagnosis other individuals (validation group) who may suffer from colorectal cancer or adenoma.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-09-16
• Study First Submitted QC: 2018-09-16
• Last Update Submitted: 2018-09-16
• Study First Posted: 2018-09-18
• Last Update Posted: 2018-09-18
• Study Start: 2018-12-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma	6 months	Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma in training group and validation group

Trial Locations

Locations (1)

Wenju Chang; 🇨🇳 Shanghai, Shanghai, China