Clinical trial NCT05839834: Blood Cell RNA-Based Cancer Detection
Official title: A Blinded Prospective Study on Development and Validation of the Blood Cell RNA-Based Cancer Detection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neoplasms
Cancer
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed cancer patients and healthy donors will be recruited from medical centers.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and specificity of cancer detection
timeFrame: 1 year
measure: Accuracy of TOO prediction
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zheng Wang
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Zheng Wang, MD/PhD
role: STUDY_CHAIR
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