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Blood Cell RNA-Based Cancer Detection

A Blinded Prospective Study on Development and Validation of the Blood Cell RNA-Based Cancer Detection

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05839834
Acronym
eRBCDet
Enrollment
5000
Registered
2023-05-03
Start date
2021-02-08
Completion date
2024-12-08
Last updated
2024-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Neoplasms

Brief summary

Early diagnosis of cancer may provide patients with more treatment options and hopefully prolong survival. The purpose of this multi-center study is to collect peripheral blood from newly diagnosed cancer patients and healthy donors to establish a blood cell RNA-based model for the differentiation of cancer patients and healthy donors. The area under the receiver operating characteristic (AUROC), sensitivity and specificity of the test in the early detection of multiple cancers will be measured.

Interventions

DIAGNOSTIC_TESTBlood test

RNA sequencing of peripheral blood cells

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

for All the Participants 1. Age 18 years or older 2. Provide informed consent

Exclusion criteria

for All the Participants: 1. Pregnancy or lactating women 2. Received a blood transfusion within 1 month 3. Received anti-cancer treatment within 3 years 4. Known prior diagnosis of cancer 5. Poor health status or unfit to tolerate blood draw

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity and specificity of cancer detection1 yearSensitivity and specificity of the early detection of 30 types of cancers of a blood cell RNA-based cancer detection test
Accuracy of TOO prediction1 yearAccuracy of the tissue of origin (TOO) prediction of a blood cell RNA-based cancer detection test

Countries

China

Contacts

Primary ContactZheng Wang, MD/PhD
zhengwang@hust.edu.cn+86 27 85726612
Backup ContactLuming Xu
lumingxu@hust.edu.cn+86 27 85726612

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026