Screening and differentiating common cancers using blood tests
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
This study is testing a blood test that looks for signs of common cancers to see if it can help identify them early in people with and without suspicious lumps.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3200 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Air Force Military Medical University, China Academic / other |
| Locations | 8 sites (Guangzhou, Guangdong and 7 other locations) |
| Trial ID | NCT06036563 on ClinicalTrials.gov |
What this trial studies
This observational study aims to screen and differentiate various common cancers by analyzing cell-free DNA from peripheral blood samples. Participants, both with and without suspicious lesions, will provide blood samples for sequencing to develop a model that can effectively classify cancers, particularly in their early stages. The study will involve the collection of 15-20ml of blood and follow-up calls to monitor participants. The goal is to assess the effectiveness of this liquid biopsy approach in cancer diagnosis.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 20 to 80, either newly diagnosed with specific cancers or those without a cancer diagnosis.
Not a fit: Patients with uncontrolled systemic diseases or those who have undergone cancer treatment in the past three years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate cancer diagnoses, improving patient outcomes.
How similar studies have performed: Other studies utilizing liquid biopsy and cell-free DNA sequencing have shown promise in cancer detection, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong and 7 other locations
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Guangzhou, Guangdong, China (Not_yet_recruiting)
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
- First Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
- People's Hospital of Ningxia Hui Autonomous Region — Yinchuan, Ningxia, China (Not_yet_recruiting)
- First Affiliated Hospital of Air Force Military Medical University — Xi'an, Shaanxi, China (Recruiting)
- Tang-du Hospital — Xi'an, Shaanxi, China (Recruiting)
- Guanxian People's Hospital — Liaocheng, Shandong, China (Recruiting)
- Affiliated Cancer Hospital of Xinjiang Medical University — Ürümqi, China (Recruiting)
Study contacts
- Study coordinator: Yanglin Pan, MD
- Email: yanglinpan@hotmail.com
- Phone: 86-13991811225
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.