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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Device: Multi-cancer early detection test

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 Type: Observational
• Enrollment (Actual): 2305

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be re recruited from medical centers and assigned into two arms, including participants with new diagnosis of cancers and healthy participants.

Description

Inclusion Criteria for Cancer Arm Participants:

• Ability to provide a written informed consent
• 40-75 years old
• Ability to comply with study procedures
• Confirmed diagnosis or suspicious cases of one of the 9 types of cancers within 42 days prior to study blood draw.
• No prior anti-cancer therapy (local or systematic) prior to study blood draw

Exclusion Criteria for Cancer Arm Participants:

• Pregnancy or lactating women
• Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
• Recipients of blood transfusion within 7 days prior to study blood draw
• Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer
• Known prior diagnosis of malignancies, other current malignant diseases or multiple primary tumors
• No confirmed diagnosis of cancer by histopathological or radiological assessments within 42 days of study blood draw, or diagnosis of a benign disease or precancerous lesions by histopathological assessments, or inability to characterize whether the lesion is malignant or benign

Inclusion Criteria for Healthy Arm Participants:

• Ability to provide a written informed consent
• 40-75 years old
• No cancer-related symptoms or discomfort within 30 days prior to study blood draw
• Ability to comply with study procedures
• No clinically significant finding by laboratory tests and radiology examinations

Exclusion Criteria for Healthy Arm Participants:

• Pregnancy or lactating women
• Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
• Recipients of blood transfusion within 7 days prior to study blood draw
• Clinically significant or uncontrolled comorbidities
• Prior or ongoing treatment of cancer within 3 years prior to study blood draw

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cancer Arm; Participants with new diagnosis of cancer, from whom blood samples will be collected.	Device: Multi-cancer early detection test; Blood collection and multi-cancer early detection test
Healthy Arm; Participants without known presence of malignancies or benign diseases, from whom blood samples will be collected.	Device: Multi-cancer early detection test; Blood collection and multi-cancer early detection test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	9 months

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: Guangzhou Burning Rock Dx Co., Ltd.
• Investigators: Principal Investigator: Jie Wang, M.D., Ph.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 21, 2024
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: early detection; cancer; liquid biopsy; cell-free DNA (cfDNA); microRNA (miRNA)
• Other Study ID Numbers: RSCD2020006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No