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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Device: Multi-cancer early detection test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 |  | 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 |  | 9 months | 
| 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 |  | 9 months | 
| Sensitivity, specificity and TOO accuracy of combined assays of cfDNA mutation, cfDNA methylation and/or miRNA expression in early detection of cancers |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, liquid biopsy, cell-free DNA (cfDNA), microRNA (miRNA), early detection