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

NCT06036563 | Recruiting DMC

• 1 other identifier: KY20232260-F-1
• Study Type: observational
• Target: 3,200
• Locations: 1 country
• Sites: 8

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 15\~20ml of blood and 1\~2 telephone follow-up calls.

Conditions

Cancer Diagnosis; LungCancer; Gastric Cancer; Liver Cancer; Colorectal Cancer; Esophagus Cancer; Breast Cancer; Pancreas Cancer

Keywords

multicancer screening; liquid biopsy; cell-free DNA; methylation; machine learning

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PASS 21.0 is used to calculate the sample size for diagnostic tests. Based on the specificity and sensitivity of different cancer diagnoses in current and reported studies, the specificity is preset at 98%, and the sensitivity is preset at 75%. A two-sided test is chosen, with a confidence level of 1-α=0.9, and a confidence interval width of 10%. The minimum sample size for the diagnostic test is calculated as follows: each type of cancer should have no less than 202 cases in the diagnostic test, and the total number of cancer subjects should not be less than 1414. The ratio of cancer subjects to non-cancer subjects is set at 1:1. Considering the possibility of loss to follow-up, unqualified sample quality, and dropout during the study, the sample size for this study is preset at 3200.

You may qualify if:

• \>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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (8)

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

Guangzhou, Guangdong, 510000, China

NOT YET RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

First Hospital of China Medical University

Shenyang, Liaoning, 110000, China

NOT YET RECRUITING

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, 750000, China

NOT YET RECRUITING

First Affiliated Hospital of Air Force Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

Tang-du Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Guanxian People's Hospital

Liaocheng, Shandong, 252500, China

RECRUITING

Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 36096847 BACKGROUND

• 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.

  PMID: 36849097 BACKGROUND

• 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.

  PMID: 36400018 BACKGROUND

• 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.

  PMID: 37330052 BACKGROUND

• 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.

  PMID: 37302583 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

15\~20ml peripheral venous blood sample from each participant.

MeSH Terms

Conditions

Stomach Neoplasms; Liver Neoplasms; Colorectal Neoplasms; Esophageal Neoplasms; Breast Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Liver Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Yanglin Pan, MD

CONTACT

86-13991811225; yanglinpan@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: September 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)