Prospective Screening and Differentiating Common Cancers Using Peripheral Blood Cell-Free DNA Sequencing

Study Overview
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Brief Summary
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The goal of this observational study is to screen and differentiate common cancers in participants with or without suspicious lesions. The main question the investigators aim to answer is: Can the developed model, using peripheral blood cell-free DNA sequencing, work well in screening and classifying common cancers especially in the early stages? Participants will undergo the collection of 15 20ml of blood and 1 2 telephone follow-up calls.

Official Title
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A Multicenter Prospective Diagnostic Test: Screening and Differentiating Common Cancers (Cancers of Lung, Stomach, Colorectum, Esophagus, Liver, Breast and Pancreas) Based on Peripheral Blood Cell-Free DNA Sequencing

Conditions
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Cancer Diagnosis, LungCancer, Gastric Cancer, Liver Cancer, Colorectal Cancer, Esophagus Cancer, Breast Cancer, Pancreas Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >20 and < 80 years old. Cancer group: Newly diagnosed cancer patients with a confirmed pathological diagnosis within 90 days before blood collection or within 30 days after blood collection, including lung cancer, esophageal cancer, breast cancer, stomach cancer, colorectal cancer, liver cancer, and pancreatic cancer. Non-cancer group: Individuals who have not been diagnosed with cancer during routine physical examinations and one-year follow-up. Exclusion Criteria: Uncontrolled or active systemic diseases, such as autoimmune diseases, tuberculosis, AIDS, etc. New onset, recurrence, or exacerbation of various inflammations within 2 weeks before blood collection, or the presence of fever, use of corticosteroids. New onset or exacerbation of thromboembolic diseases, hemorrhagic diseases, or those who have received allogeneic blood transfusion within 1 month before blood collection. Any cancer treatment performed within the past 3 years. Individuals who have undergone organ or bone marrow transplantation. Participants during pregnancy or lactation. Individuals with malnutrition, severe mental illness, or genetic diseases. Other diseases or conditions deemed by the physician as unsuitable for participation in this study. Individuals who are unable to sign an informed consent form.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multicenter prospective cancer-screening cohort<br>The cohort, including cancer patients and non-cancer patients, will be prospectively enrolled in from different departments and centers. The focused cancers include lung cancer, gastric cancer, colorectal cancer, liver cancer, esophagus cancer, breast cancer and pancreas cancer. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic accuracy | This refers to the ability of the test (peripheral blood cell-free DNA sequencing) to correctly classify individuals into the categories of having or not having the disease. It is a measure of the test's overall effectiveness. The reference test is histological test for cancers or one-year follow-up for non-cancers. | Immediately after test completion | 
| sensitivity | This is the ability of the test (peripheral blood cell-free DNA sequencing) to correctly identify those with the disease. It is the proportion of true positive results (those with the disease who test positive) to the total number of individuals who actually have the disease. The reference test is histological test for cancers or one-year follow-up for non-cancers. | Immediately after test completion | 
| specificity | This is the ability of the test (peripheral blood cell-free DNA sequencing) to correctly identify those without disease. It is the proportion of true negative results (those without the disease who test negative) to the total number of individuals who actually do not have the disease. The reference test is histological test for cancers or one-year follow-up for non-cancers. | Immediately after test completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multicancer screening, liquid biopsy, cell-free DNA, methylation, machine learning