Prospective Screening and Differentiating Common Cancers Using Peripheral Blood Cell-Free DNA Sequencing
NCT ID: NCT06036563
Last Updated: 2024-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3200 participants
OBSERVATIONAL
2023-09-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
80 Years
ALL
Yes
Sponsors
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Air Force Military Medical University, China
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Tang-Du Hospital
OTHER
The First Affiliated Hospital of Guangzhou Medical University
OTHER
First Hospital of China Medical University
OTHER
People's Hospital of Ningxia Hui Autonomous Region
OTHER
Xinjiang Medical University
OTHER
Guanxian People's Hospital
UNKNOWN
Responsible Party
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Yanglin Pan
Professor
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Fengxia Gan, PhD
Role: primary
Miao He, MD
Role: primary
Xinmeng Yang, BN
Role: primary
Gang Sun, MD
Role: primary
References
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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.
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.
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.
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.
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 Oct;79(4):933-944. doi: 10.1016/j.jhep.2023.05.039. Epub 2023 Jun 10.
Other Identifiers
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KY20232260-F-1
Identifier Type: -
Identifier Source: org_study_id
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