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.
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.
Study Type
OBSERVATIONAL
Enrollment
2,305
Blood collection and multi-cancer early detection test
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
Sensitivity of early detection of cancers and Tissue of origin (TOO) accuracy of 3 assays of cfDNA mutation, cfDNA methylation and miRNA expression when specificity was 90%, 95% or 98% in healthy participants
Sensitivity of early detection of cancers and Tissue of origin (TOO) accuracy of 3 assays of cfDNA mutation, cfDNA methylation and miRNA expression when specificity was 90%, 95% or 98% in healthy participants
Time frame: 9 months
Sensitivity, specificity and TOO accuracy of an assay of cfDNA mutation in various types of cancer in different stages
Sensitivity, specificity and TOO accuracy of an assay of cfDNA mutation in various types of cancer in different stages
Time frame: 9 months
Sensitivity, specificity and TOO accuracy of an assay of cfDNA methylation in various types of cancer in different stages
Sensitivity, specificity and TOO accuracy of an assay of cfDNA methylation in various types of cancer in different stages
Time frame: 9 months
Sensitivity, specificity and TOO accuracy of an assay of miRNA expression in various types of cancer in different stages
Sensitivity, specificity and TOO accuracy of an assay of miRNA expression in various types of cancer in different stages
Time frame: 9 months
Sensitivity, specificity and TOO accuracy of combined assays of cfDNA mutation, cfDNA methylation and/or miRNA expression in early detection of cancers
Sensitivity, specificity and TOO accuracy of combined assays of cfDNA mutation, cfDNA methylation and/or miRNA expression in early detection of cancers
Time frame: 9 months
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