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The Unintrusive Detection of EaRly-stage Cancers

NCT04820868 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2508

Last updated 2023-03-16

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Multi-cancer early detection test

Blood collection and multi-cancer early detection test

Sponsors & Collaborators

  • Guangzhou Burning Rock Dx Co., Ltd.

    collaborator INDUSTRY

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Qiang Gao, M.D. · Shanghai Zhongshan Hospital

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-23
Primary Completion
2021-11-30
Completion
2022-04-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04820868 on ClinicalTrials.gov