Clinical trial NCT03676075: 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
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Adenoma
Keywords: colorectal cancer
early diagnosis
5-hydroxymethylcytosine
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults diagnosed with colorectal cancer, adenoma or with normal colonoscopy.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Wenju Chang
state: Shanghai
Study officials:
References: