Breast Cancer, Cancer Diagnosis, Colorectal Cancer, Esophagus Cancer, Gastric Cancer, Liver Cancer, LungCancer, Pancreas Cancer
Conditions
Keywords
multicancer screening, liquid biopsy, cell-free DNA, methylation, machine learning
Brief summary
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.
Interventions
None listed
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Tang-Du Hospital
The First Affiliated Hospital of Guangzhou Medical University
First Hospital of China Medical University
People's Hospital of Ningxia Hui Autonomous Region
Xinjiang Medical University
Guanxian People's Hospital
Air Force Military Medical University, China
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. \>20 and \< 80 years old. 2. 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
1. Uncontrolled or active systemic diseases, such as autoimmune diseases, tuberculosis, AIDS, etc. 2. New onset, recurrence, or exacerbation of various inflammations within 2 weeks before blood collection, or the presence of fever, use of corticosteroids. 3. New onset or exacerbation of thromboembolic diseases, hemorrhagic diseases, or those who have received allogeneic blood transfusion within 1 month before blood collection. 4. Any cancer treatment performed within the past 3 years. 5. Individuals who have undergone organ or bone marrow transplantation. 6. Participants during pregnancy or lactation. 7. Individuals with malnutrition, severe mental illness, or genetic diseases. 8. Other diseases or conditions deemed by the physician as unsuitable for participation in this study. 9. Individuals who are unable to sign an informed consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diagnostic accuracy | Immediately after test completion | 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. |
| sensitivity | Immediately after test completion | 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. |
| specificity | Immediately after test completion | 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. |
Countries
China
Contacts
Primary ContactYanglin Pan, MD
Outcome results
None listed