NCT04972201

A Proof of Concept Study of Pan-cancer Early Detection by Liquid Biopsy

The Performance of a Pan-cancer Early Detection Model Based on Liquid Biopsy of Various-omics Biomarkers: a Proof of Concept Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,305 (actual)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: —

Summary

PROMISE is a multi-center, prospective and proof of concept study aimed to evaluate the performance of 3 prototype assays of cell-free DNA (cfDNA) mutation, cfDNA methylation and microRNA (miRNA) expression in early detection of multi-cancer. Assay(s) will be selected for further development. The study will enroll approximately 2035 participants, including participants with cancers and healthy participants.

Detailed description

Blood samples will be prospectively collected from cancer patients and non-cancer individuals. Targeted cell-free DNA (cfDNA) methylation panel of \~490,000 CpG sites, a 168-gene mutation panel and 16 proteins will be applied. Participants will be stratified by age and clinical status and split into the training and the testing sets. The multi-cancer detection blood test models were developed on training set and validated on testing set.

Conditions

• Cancer

Interventions

Type	Name	Description
DEVICE	Multi-cancer early detection test	Blood collection and multi-cancer early detection test

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-03-31
• Completion: 2022-06-30
• First posted: 2021-07-22
• Last updated: 2024-12-27

Locations

1 site across 1 country: China