Trials / Completed
CompletedNCT04820868
The Unintrusive Detection of EaRly-stage Cancers
A Blinded Prospective Study on Validation of the Performance of a cfDNA Methylation-based Model for Early Cancer Detection
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,508 (actual)
- Sponsor
- Shanghai Zhongshan Hospital · Academic / Other
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- —
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
| Type | Name | Description |
|---|---|---|
| DEVICE | Multi-cancer early detection test | Blood collection and multi-cancer early detection test |
Timeline
- Start date
- 2021-04-23
- Primary completion
- 2021-11-30
- Completion
- 2022-04-30
- First posted
- 2021-03-29
- Last updated
- 2023-03-16
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04820868. Inclusion in this directory is not an endorsement.