Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06220617

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

Led by Zhejiang University · Updated on 2024-01-30

3600

Participants Needed

6

Research Sites

180 weeks

Total Duration

On this page

Sponsors

Z

Zhejiang University

Lead Sponsor

N

New Horizon Health Technology Co., Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged over 18 years
  • Confirmed colorectal adenocarcinoma or advanced adenoma through colonoscopy and pathology (case arm)
  • No history of colorectal adenomas or sessile serrated polyps (general-risk control arm)
  • No history of inflammatory bowel disease for 8-10 years (general-risk control arm)
  • No family history of colorectal cancer in first-degree relatives (general-risk control arm)
  • At least one of the following for high-risk control arm: Asia-Pacific Colorectal Screening score 4, family history of colorectal cancer in first-degree relatives, positive fecal occult blood test, two or more of chronic diarrhea, chronic constipation, mucous bloody stools, psychological stimulation, chronic appendicitis or appendectomy, chronic biliary disease or cholecystectomy
  • Inflammatory bowel disease (high-risk control arm)
  • Confirmed absence of colorectal malignancy or advanced adenomas via colonoscopy (control arm)
  • Provision of informed consent prior to study procedures, sampling, and analyses
Not Eligible

You will not qualify if you...

  • History of other malignant tumors excluding non-melanoma skin cancer
  • Prior colorectal cancer or advanced adenoma treatments including surgery, endoscopic treatment, chemotherapy, targeted therapy, immunotherapy, radiation, or neoadjuvant therapy
  • Hereditary colorectal diseases such as Lynch syndrome, familial CRC type X, familial adenomatous polyposis, MUTHY-associated polyposis, Peutz-Jeghers syndrome, juvenile polyposis syndrome, or serrated polyposis syndrome
  • Use of anti-tumor drugs like methotrexate, cyclophosphamide, mercaptopurine, or bendamustine within 30 days before blood collection
  • Blood transfusion within 2 weeks prior to blood collection
  • Prior organ, bone marrow, or stem cell transplantation
  • Pregnancy
  • Anti-infection treatment within 14 days before blood collection
  • Inability to comply with study procedures such as blood collection and examinations
  • Deemed unsuitable for clinical trial participation by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 6 locations

1

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China, 31000

Actively Recruiting

2

Sun Yat-Sen University Cancer Hospital

Guangzhou, China

Actively Recruiting

3

Yunnan cancer hospital

Kunming, China

Actively Recruiting

4

Jiangsu province hospital

Nanjing, China

Actively Recruiting

5

The first affiliated hospital of Xi'an Jiaotong University

Xi'an, China

Actively Recruiting

6

Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University

Zhengzhou, China

Actively Recruiting

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Research Team

K

Kefeng Ding, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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