Multi-omics approach for early detection of colorectal cancer

Multi-omics Study for Early Detection of Colorectal Cancer Based on Liquid Biopsy Technology

This study is testing a new way to spot colorectal cancer early by looking at blood samples from people with cancer and healthy individuals to see if certain markers can help predict the disease.

Quick facts

• Study type: Observational
• Enrollment: 3600 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, methotrexate, cyclophosphamide
• Locations: 6 sites (Hangzhou, Zhejiang and 5 other locations)
• Trial ID: NCT06220617 on ClinicalTrials.gov

What this trial studies

This observational study aims to develop and validate a prediction model for early detection of colorectal cancer (CRC) using multi-omics markers from blood samples. It will enroll 3,600 participants, divided into cancer and control arms, with the cancer arm including patients with CRC and advanced adenoma. Blood samples will undergo next-generation sequencing to analyze cell-free DNA and microRNA, and machine learning techniques will be employed to construct the prediction model. The study will also focus on optimizing the model's clinical performance through external validation.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years with confirmed colorectal adenocarcinoma or advanced adenoma, as well as individuals at general or high risk for colorectal cancer.

Not a fit: Patients with a history of colorectal adenomas, inflammatory bowel disease, or those without any risk factors for colorectal cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a non-invasive method for early detection of colorectal cancer, potentially improving patient outcomes.

How similar studies have performed: Other studies utilizing multi-omics approaches for cancer detection have shown promise, indicating potential for success in this novel application.

Eligibility criteria

Inclusion Criteria for Case Arm:

1. Aged over 18 years.
2. Participants confirmed with colorectal adenocarcinoma or advanced adenoma through colonoscopy and pathological examination.
3. Provision of informed consent prior to any study specific procedures, sampling, and analyses.

Inclusion Criteria for Control Arm:

1. Individuals of "General risk arm" should meet all the following criteria:

   1. No history of colorectal adenomas or sessile serrated polyps.
   2. No history of inflammatory bowel disease (8-10 years ).
   3. No family history (first-degree relatives) of colorectal cancer.
2. Individuals of "High-risk arm" should meet at least one of the following criteria:

   1. Asia-Pacific Colorectal Screening (APC) score ≥ 3.
   2. Family history (first-degree relatives) of colorectal cancer.
   3. History of positive fecal occult blood test.
   4. 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.
   5. Individuals with inflammatory bowel disease.
3. All participants must be confirmed not to have colorectal malignancy or advanced adenomas through colonoscopy.
4. Provision of informed consent prior to any study specific procedures, sampling, and analyses.

Exclusion Criteria:

1. History of other malignant tumors (excluding non-melanoma skin cancer).
2. Prior or related treatments previously (including colorectal cancer or advanced adenoma surgery, endoscopic treatment, chemotherapy, targeted therapy, immunotherapy, radiation, neoadjuvant therapy, etc.).
3. 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.).
4. Usage of anti-tumor drugs such as methotrexate, cyclophosphamide, mercaptopurine, and bendamustine for other diseases within 30 days before blood collection.
5. Prior blood transfusion (including blood components) within the past 2 weeks.
6. Prior organ transplantation, bone marrow transplantation, or stem cell transplantation.
7. Pregnancy women.
8. Prior or current anti-infection treatment within 14 days before blood collection.
9. Inability to comply with study procedures such as blood collection and related examinations.
10. Deemed unsuitable for participation in the clinical trial by the investigator.

Where this trial is running

Hangzhou, Zhejiang and 5 other locations

• The Second Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, 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)

Study contacts

• Principal investigator: Kefeng Ding, MD — Second Affiliated Hospital, School of Medicine, Zhejiang University
• Study coordinator: Kefeng Ding, MD

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