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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03676075
• Other study ID #: METHOD-2
• Status: Recruiting
• Start date: December 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2018
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
China	Wenju Chang	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma	Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma in training group and validation group	6 months