RecruitingNCT06036563

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

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


Sponsor

Air Force Military Medical University, China

Enrollment

3,200 participants

Start Date

Sep 1, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 20 YearsMax Age: 80 Years

Inclusion Criteria3

  • \>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 Criteria9

  • 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.

Locations(8)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 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

First Affiliated Hospital of Air Force Military Medical University

Xi'an, Shaanxi, China

Tang-du Hospital

Xi'an, Shaanxi, China

Guanxian People's Hospital

Liaocheng, Shandong, China

Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, China

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NCT06036563


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