Actively Recruiting
Multi-omics Study for Early Detection of Colorectal Cancer Based on Liquid Biopsy Technology
Led by Zhejiang University · Updated on 2024-01-30
3600
Participants Needed
6
Research Sites
25 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
Researchers are conducting a multicenter observational study to develop and validate a prediction model for early detection of colorectal cancer (CRC) using multi-omics markers found in blood samples. The study aims to improve screening methods by analyzing cell-free DNA and microRNA through next-generation sequencing, combined with clinical and pathological information to enhance early diagnosis. This research involves a large group of participants categorized into cancer and control groups, including those at general and high risk for colorectal cancer. The study is divided into two main sections. The first section will build the diagnostic prediction model using data from 1,700 participants, including CRC patients, individuals with advanced adenoma, and control participants. All will provide blood samples for analysis. In the second section, the prediction model will be validated and optimized with an additional 1,900 participants, similarly grouped. Blood samples are collected from all participants, and machine learning techniques are applied to identify cancer-specific markers. Participants will be involved by providing a 10 ml blood sample and undergoing colonoscopy to confirm their health status related to colorectal cancer or advanced adenomas. Researchers will assess the sensitivity and specificity of the screening test compared to colonoscopy over an average of three years. The study includes monitoring the clinical performance of the prediction model and optimizing it based on external validation. Participants' involvement lasts through these assessments and sample collections as part of the study timeline.
CONDITIONS
Brief Title
Multi-omics Study for Early Detection of Colorectal Cancer (MOED-CRC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged over 18 years
- Confirmed colorectal adenocarcinoma or advanced adenoma through colonoscopy and pathology (case arm)
- Individuals with no history of colorectal adenomas or sessile serrated polyps, no inflammatory bowel disease for 8-10 years, and no family history of colorectal cancer (general risk control arm)
- Individuals with at least one high-risk factor such as APC score 23, family history of colorectal cancer, positive fecal occult blood test, or certain chronic gastrointestinal conditions (high-risk control arm)
- Confirmation of no colorectal malignancy or advanced adenomas through colonoscopy (control arm)
- Provision of informed consent before study procedures and sampling
You will not qualify if you...
- History of other malignant tumors except non-melanoma skin cancer
- Prior treatments for colorectal cancer or advanced adenoma including surgery, chemotherapy, targeted therapy, immunotherapy, radiation, or neoadjuvant therapy
- Patients with 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 the past 2 weeks
- Prior organ, bone marrow, or stem cell transplantation
- Pregnancy
- Anti-infection treatment within 14 days before blood collection
- Inability to comply with study procedures
- Deemed unsuitable for participation by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Throughout study participation
Participants provide a 10 ml whole blood sample for sequencing and analysis to develop and validate early detection models for colorectal cancer.
1 visit (in-person)
Duration - Up to 3 years
Participants are followed to assess sensitivity and specificity of the screening test compared to colonoscopy over an average of 3 years.
Visits as per routine clinical care
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
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4
Jiangsu province hospital
Nanjing, China
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5
The first affiliated hospital of Xi'an Jiaotong University
Xi'an, China
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6
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, China
Actively Recruiting
Research Team
K
Kefeng Ding, MD
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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