Multi-omics Study for Early Detection of Colorectal Cancer (MOED-CRC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZhejiang University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
No history of colorectal adenomas or sessile serrated polyps.
Disqualifiers
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.
Trial population
Case arm: patients with colorectal cancer or advanced adenoma. Control arm: healthy participants who have general risk or high risk of colorectal cancer
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
3,600 Participants
are grouped into 2 trial groupsGroup A: Case arm
Group B: Control arm
Trial outcomes
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.
Time frame
Through study completion, an average of 3 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhejiang University
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor institution
New Horizon Health Technology Co., Ltd
Collaborator
Source ClinicalTrials.gov