The Unintrusive Detection of EaRly-stage Cancers

Conditions

Cancer

Keywords

Cancer, Liquid biopsy, Cell-free DNA (cfDNA), Early detection

Brief summary

According to a previous study, a cell-free DNA (cfDNA) methylation-based model showed high sensitivity and specificity (80.6% and 98.3%) in blood-based multi-cancer detection. In this way, a multi-center, prospective, single-blind study (THUNDER study) is designed to further validate the performance of the cfDNA methylation-based model for early cancer detection. Blood RNA markers will also be evaluated. The study will enroll approximately 2508 participants, including participants with malignancies and healthy participants.

Naixin Liang, Zhicheng Huang, Jiayue Xu, Yadong Wang, Daoyun Wang et al. (20 authors)

Journal of Clinical Oncology2025-05-28

10.1200/jco.2025.43.16_suppl.3045

Unintrusive multi-cancer detection by circulating cell-free DNA methylation sequencing (THUNDER): development and independent validation studies.

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.

2023-02-2685 citations

10.1016/j.annonc.2023.02.010

Abstract 5116: Analytical performance of ELSA-seq, a blood-based test for early detection of multiple cancers

Bingsi Li, Jing Su, Guangliang Zhang, Jiayue Xu, Jianlong Peng et al. (14 authors)

Cancer Research2022-06-151 citations

10.1158/1538-7445.am2022-5116

Clinical validation of a multicancer detection blood test by circulating cell-free DNA (cfDNA) methylation sequencing: The THUNDER study.

Qiang Gao, Yuzi Zhang, Jiayue Xu, Guoqiang Wang, Jing Zhao et al. (11 authors)

Journal of Clinical Oncology2022-06-013 citations

10.1200/jco.2022.40.16_suppl.10544

Interventions

DEVICEMulti-cancer early detection test

Blood collection and multi-cancer early detection test

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Inclusion criteria

for All the Participants: * Ability to provide a written informed consent * 40-75 years old * Ability to comply with study procedures

Exclusion criteria

for All the Participants: * Pregnancy or lactating women * Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant * Recipients of blood transfusion within 7 days prior to study blood draw * Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer Inclusion Criteria for Cancer Arm Participants: * Confirmed diagnosis or suspicious cases of cancer within 42 days prior to study blood draw. * No prior anti-cancer therapy (local or systematic) prior to study blood draw

Design outcomes

Primary

Measure	Time frame
Sensitivity and specificity of early detection of 6 types of cancers and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model	7 months

Secondary

Measure	Time frame
Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in different stages or pathological types of cancer	7 months

Countries

China

Outcome results

None listed