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

NCT03676075 | Unknown DMC

• 1 other identifier: METHOD-2
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Adenoma

Keywords

colorectal cancer; early diagnosis; 5-hydroxymethylcytosine

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults diagnosed with colorectal cancer, adenoma or with normal colonoscopy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Wenju Chang

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral venous blood

MeSH Terms

Conditions

Colorectal Neoplasms; Adenoma; Disease

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Professor

Study Record Dates

• First Submitted: September 16, 2018
• First Posted: September 18, 2018
• Study Start: December 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: September 18, 2018

Record last verified: 2018-08

Locations

CN (1)