Multi-omics Study for Early Detection of Colorectal Cancer (MOED-CRC)

NCT06220617 | Recruiting

• 1 other identifier: MOED-CRC
• Study Type: observational
• Target: 3,600
• Locations: 1 country
• Sites: 6

Brief Summary

The primary objective of the study is to screen multi-omics markers in blood samples and construct a prediction model for CRC based on liquid biopsy, and we will further optimize the prediction model by validating its clinical performance externally.

Conditions

Colorectal Cancer; Adenomatous Polyps; Adenoma; Advanced Adenoma

Keywords

Colorectal Cancer; Colorectal Neoplasms; Adenomatous Polyps; Adenoma; Advanced adenoma

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of the screening test with comparison to colonoscopy

  Cancer specific markers will be identified to construct an early detection liquid biopsy prediction model, which will be compared with diagnostic colonoscopy.

  Through study completion, an average of 3 year

Study Arms (2)

Case arm

Prospective enrollment of participants confirmed with colorectal adenocarcinoma or advanced adenoma

Control arm

Prospective enrollment of healthy participants who have general risk or high risk of colorectal cancer

Eligibility Criteria

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

Study Population

Case arm: patients with colorectal cancer or advanced adenoma. Control arm: healthy participants who have general risk or high risk of colorectal cancer

You may qualify if:

• Aged over 18 years.
• Participants confirmed with colorectal adenocarcinoma or advanced adenoma through colonoscopy and pathological examination.
• Provision of informed consent prior to any study specific procedures, sampling, and analyses.
• Individuals of "General risk arm" should meet all the following criteria:
• No history of colorectal adenomas or sessile serrated polyps.
• No history of inflammatory bowel disease (8-10 years ).
• No family history (first-degree relatives) of colorectal cancer.
• Individuals of "High-risk arm" should meet at least one of the following criteria:
• Asia-Pacific Colorectal Screening (APC) score ≥ 3.
• Family history (first-degree relatives) of colorectal cancer.
• History of positive fecal occult blood test.
• Any 2 of the following: chronic diarrhea, chronic constipation, mucous bloody stools, history of psychological stimulation, history of chronic appendicitis or appendectomy, history of chronic biliary disease or cholecystectomy.
• Individuals with inflammatory bowel disease.
• All participants must be confirmed not to have colorectal malignancy or advanced adenomas through colonoscopy.
• Provision of informed consent prior to any study specific procedures, sampling, and analyses.

You may not qualify if:

• History of other malignant tumors (excluding non-melanoma skin cancer).
• Prior or related treatments previously (including colorectal cancer or advanced adenoma surgery, endoscopic treatment, chemotherapy, targeted therapy, immunotherapy, radiation, neoadjuvant therapy, etc.).
• Patients with hereditary colorectal diseases (including Lynch syndrome, familial CRC type X (FCCX), familial adenomatous polyposis (FAP), MUTHY-associated polyposis (MAP), Peutz-Jeghers syndrome (PJS), juvenile polyposis syndrome (JPS), serrated polyposis syndrome (SPS), etc.).
• Usage of anti-tumor drugs such as methotrexate, cyclophosphamide, mercaptopurine, and bendamustine for other diseases within 30 days before blood collection.
• Prior blood transfusion (including blood components) within the past 2 weeks.
• Prior organ transplantation, bone marrow transplantation, or stem cell transplantation.
• Pregnancy women.
• Prior or current anti-infection treatment within 14 days before blood collection.
• Inability to comply with study procedures such as blood collection and related examinations.
• Deemed unsuitable for participation in the clinical trial by the investigator.

Sponsors & Collaborators

• Zhejiang University: lead
• New Horizon Health Technology Co., Ltd: collaborator

Study Sites (6)

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 31000, China

RECRUITING

Sun Yat-Sen University Cancer Hospital

Guangzhou, China

RECRUITING

Yunnan cancer hospital

Kunming, China

RECRUITING

Jiangsu province hospital

Nanjing, China

RECRUITING

The first affiliated hospital of Xi'an Jiaotong University

Xi'an, China

RECRUITING

Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University

Zhengzhou, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

MeSH Terms

Conditions

Colorectal Neoplasms; Adenomatous Polyps; Adenoma

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

Study Officials

• Kefeng Ding, MD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kefeng Ding, MD

CONTACT

86-571-87784827; dingkefeng@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: January 24, 2024
• Study Start: January 11, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)