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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06036563
• Other study ID #: KY20232260-F-1
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Air Force Military Medical University, China
• Contact: Yanglin Pan, MD
• Phone: 86-13991811225
• Email: yanglinpan[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3200
• Est. completion date: December 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Cancer Diagnosis
• Colorectal Cancer
• Esophageal Neoplasms
• Esophagus Cancer
• Gastric Cancer
• Liver Cancer
• Lung Neoplasms
• LungCancer
• Pancreas Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Guanxian People's Hospital	Liaocheng	Shandong
China	First Hospital of China Medical University	Shenyang	Liaoning
China	Affiliated Cancer Hospital of Xinjiang Medical University	Urumqi
China	First Affiliated Hospital of Air Force Military Medical University	Xi'an	Shaanxi
China	Tang-du Hospital	Xi'an	Shaanxi
China	People's Hospital of Ningxia Hui Autonomous Region	Yinchuan	Ningxia

Sponsors (8)

Lead Sponsor	Collaborator
Air Force Military Medical University, China	First Hospital of China Medical University, Guanxian People's Hospital, People's Hospital of Ningxia Hui Autonomous Region, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Tang-Du Hospital, The First Affiliated Hospital of Guangzhou Medical University, Xinjiang Medical University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic accuracy	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.	Immediately after test completion
Primary	sensitivity	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.	Immediately after test completion
Primary	specificity	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.	Immediately after test completion