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Recruiting

NCT Number: NCT05839834

Blood Cell RNA-Based Cancer Detection

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.

Recruiting

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Key information

Conditions

Neoplasms Cancer

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for All the Participants

  • Age 18 years or older
  • Provide informed consent

Exclusion criteria

for All the Participants:

  • Pregnancy or lactating women
  • Received a blood transfusion within 1 month
  • Received anti-cancer treatment within 3 years
  • Known prior diagnosis of cancer
  • Poor health status or unfit to tolerate blood draw

Treatment and study plan

Blood test

Diagnostic Test

RNA sequencing of peripheral blood cells

Primary outcomes

  1. Sensitivity and specificity of cancer detection

    Time frame: 1 year

    Sensitivity and specificity of the early detection of 30 types of cancers of a blood cell RNA-based cancer detection test

  2. Accuracy of TOO prediction

    Time frame: 1 year

    Accuracy of the tissue of origin (TOO) prediction of a blood cell RNA-based cancer detection test

Study contacts

Contact information is provided by the study sponsor or research team.

Luming Xu

CONTACT

[email protected]

+86 27 85726612

Zheng Wang, MD/PhD

CONTACT

[email protected]

+86 27 85726612

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: eRBCDet

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 3, 2023
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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