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

Completed

• Conditions: Cancer
• Interventions: Device: Multi-cancer early detection test

• Registration Number: NCT04972201
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief 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.

Study Timeline

• Status Verified: 2021-06
• Study Start: 2021-06-01
• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-22
• Primary Completion: 2022-03-31
• Study Completion: 2022-06-30
• Last Update Submitted: 2024-12-21
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2305

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancer Arm	Multi-cancer early detection test	Participants with new diagnosis of cancer, from whom blood samples will be collected.
Healthy Arm	Multi-cancer early detection test	Participants without known presence of malignancies or benign diseases, from whom blood samples will be collected.

Primary Outcome Measures

Name	Time	Method
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	9 months	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

Secondary Outcome Measures

Name	Time	Method
Sensitivity, specificity and TOO accuracy of an assay of cfDNA mutation in various types of cancer in different stages	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 methylation in various types of cancer in different stages	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 miRNA expression in various types of cancer in different stages	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 combined assays of cfDNA mutation, cfDNA methylation and/or miRNA expression in early detection of cancers	9 months	Sensitivity, specificity and TOO accuracy of combined assays of cfDNA mutation, cfDNA methylation and/or miRNA expression in early detection of cancers

Trial Locations

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China