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

Recruiting

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

• Registration Number: NCT06036563
• Lead Sponsor: Air Force Military Medical University, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Study First Submitted: 2023-09-07
• Study First Submitted QC: 2023-09-07
• Study First Posted: 2023-09-14
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-08
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (8)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

First Affiliated Hospital of Air Force Military Medical University; 🇨🇳 Xi'an, Shaanxi, China

Tang-du Hospital; 🇨🇳 Xi'an, Shaanxi, China

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

People's Hospital of Ningxia Hui Autonomous Region; 🇨🇳 Yinchuan, Ningxia, China

Guanxian People's Hospital; 🇨🇳 Liaocheng, Shandong, China

Affiliated Cancer Hospital of Xinjiang Medical University; 🇨🇳 Urumqi, China