Prospective Screening and Differentiating Common Cancers Using Peripheral Blood Cell-Free DNA Sequencing
Study Details
Study Description
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 1520ml of blood and 12 telephone follow-up calls.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Multicenter prospective cancer-screening cohort 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. |
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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20 and < 80 years old.
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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:
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Uncontrolled or active systemic diseases, such as autoimmune diseases, tuberculosis, AIDS, etc.
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New onset, recurrence, or exacerbation of various inflammations within 2 weeks before blood collection, or the presence of fever, use of corticosteroids.
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New onset or exacerbation of thromboembolic diseases, hemorrhagic diseases, or those who have received allogeneic blood transfusion within 1 month before blood collection.
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Any cancer treatment performed within the past 3 years.
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Individuals who have undergone organ or bone marrow transplantation.
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Participants during pregnancy or lactation.
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Individuals with malnutrition, severe mental illness, or genetic diseases.
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Other diseases or conditions deemed by the physician as unsuitable for participation in this study.
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Individuals who are unable to sign an informed consent form.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Guangzhou | Guangdong | China | 510000 |
| 2 | The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China | 510000 |
| 3 | First Hospital of China Medical University | Shenyang | Liaoning | China | 110000 |
| 4 | People's Hospital of Ningxia Hui Autonomous Region | Yinchuan | Ningxia | China | 750000 |
| 5 | First Affiliated Hospital of Air Force Military Medical University | Xi'an | Shaanxi | China | 710032 |
| 6 | Tang-du Hospital | Xi'an | Shaanxi | China | 710032 |
| 7 | Guanxian People's Hospital | Liaocheng | Shandong | China | 252500 |
Sponsors and Collaborators
- Air Force Military Medical University, China
- 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
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Fan R, Chen L, Zhao S, Yang H, Li Z, Qian Y, Ma H, Liu X, Wang C, Liang X, Bai J, Xie J, Fan X, Xie Q, Hao X, Wang C, Yang S, Gao Y, Bai H, Dou X, Liu J, Wu L, Jiang G, Xia Q, Zheng D, Rao H, Xia J, Shang J, Gao P, Xie D, Yu Y, Yang Y, Gao H, Liu Y, Sun A, Jiang Y, Yu Y, Niu J, Sun J, Wang H, Hou J. Novel, high accuracy models for hepatocellular carcinoma prediction based on longitudinal data and cell-free DNA signatures. J Hepatol. 2023 Jun 10:S0168-8278(23)00416-6. doi: 10.1016/j.jhep.2023.05.039. Online ahead of print.
- Gao Q, Lin YP, Li BS, Wang GQ, Dong LQ, Shen BY, Lou WH, Wu WC, Ge D, Zhu QL, Xu Y, Xu JM, Chang WJ, Lan P, Zhou PH, He MJ, Qiao GB, Chuai SK, Zang RY, Shi TY, Tan LJ, Yin J, Zeng Q, Su XF, Wang ZD, Zhao XQ, Nian WQ, Zhang S, Zhou J, Cai SL, Zhang ZH, Fan J. Unintrusive multi-cancer detection by circulating cell-free DNA methylation sequencing (THUNDER): development and independent validation studies. Ann Oncol. 2023 May;34(5):486-495. doi: 10.1016/j.annonc.2023.02.010. Epub 2023 Feb 26.
- Helzer KT, Sharifi MN, Sperger JM, Shi Y, Annala M, Bootsma ML, Reese SR, Taylor A, Kaufmann KR, Krause HK, Schehr JL, Sethakorn N, Kosoff D, Kyriakopoulos C, Burkard ME, Rydzewski NR, Yu M, Harari PM, Bassetti M, Blitzer G, Floberg J, Sjostrom M, Quigley DA, Dehm SM, Armstrong AJ, Beltran H, McKay RR, Feng FY, O'Regan R, Wisinski KB, Emamekhoo H, Wyatt AW, Lang JM, Zhao SG. Fragmentomic analysis of circulating tumor DNA-targeted cancer panels. Ann Oncol. 2023 Sep;34(9):813-825. doi: 10.1016/j.annonc.2023.06.001. Epub 2023 Jun 16.
- Jamshidi A, Liu MC, Klein EA, Venn O, Hubbell E, Beausang JF, Gross S, Melton C, Fields AP, Liu Q, Zhang N, Fung ET, Kurtzman KN, Amini H, Betts C, Civello D, Freese P, Calef R, Davydov K, Fayzullina S, Hou C, Jiang R, Jung B, Tang S, Demas V, Newman J, Sakarya O, Scott E, Shenoy A, Shojaee S, Steffen KK, Nicula V, Chien TC, Bagaria S, Hunkapiller N, Desai M, Dong Z, Richards DA, Yeatman TJ, Cohn AL, Thiel DD, Berry DA, Tummala MK, McIntyre K, Sekeres MA, Bryce A, Aravanis AM, Seiden MV, Swanton C. Evaluation of cell-free DNA approaches for multi-cancer early detection. Cancer Cell. 2022 Dec 12;40(12):1537-1549.e12. doi: 10.1016/j.ccell.2022.10.022. Epub 2022 Nov 17.
- Nikanjam M, Kato S, Kurzrock R. Liquid biopsy: current technology and clinical applications. J Hematol Oncol. 2022 Sep 12;15(1):131. doi: 10.1186/s13045-022-01351-y.
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