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

Air Force Military Medical University of People's Liberation Army

Status: Enrolling

Conditions: Breast Cancer; Esophagus Cancer; Gastric Cancer; Cancer Diagnosis; Pancreas Cancer; LungCancer; Liver Cancer; Colorectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06036563

KY20232260-F-1

Details and patient eligibility

About

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.

Enrollment: 3,200 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

3,200 participants in 1 patient group

Multicenter prospective cancer-screening cohort

Description:

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.