Pan-canceR Early-Stage deteCtion by lIquid Biopsy tEchNique projecT

Study Overview
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Brief Summary
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PRESCIENT is a multi-center, prospective observational study aimed to detect cancers early by combined assays for serum protein markers and cell-free DNA (cfDNA) methylation markers. Blood RNA markers will also be evaluated. The study will enroll approximately 11879 participants, including participants with malignancies or benign diseases, and healthy participants.

Official Title
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Pan-cancer Early-stage Detection by Liquid Biopsy in Peripheral Blood: a Multi-center, Prospective Observational 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 All the Participants: Ability to provide a written informed consent 40-75 years old Exclusion Criteria for All the Participants: Inability to comply with study procedures 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 Inclusion Criteria for Cancer Arm Participants: Confirmed diagnosis or suspicious cases of one of the 22 types of malignancies within 42 days prior to study blood draw No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw Exclusion Criteria for Cancer Arm Participants: 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 by histopathological assessments, or inability to characterize whether the lesion is malignant or benign Non-small-cell lung cancer patients with ground-class nodularity by radiological examination Inclusion Criteria for Benign Diseases Arm Participants: Confirmed diagnosis of benign diseases corresponding to the tumor types in the Cancer Arm by histopathological or radiological assessments within 90 days prior to study blood draw No prior treatment of benign diseases prior to study blood draw Exclusion Criteria for Benign Diseases Arm Participants: History of malignancies Current malignancies or precancerous lesions No confirmed diagnosis of a benign disease by radiological, endoscopic or histopathological assessments within 42 days of study blood draw, or inability to characterize whether the lesion is malignant or benign Inclusion Criteria for Non-tumor (Healthy) Arm Participants: No cancer-related symptoms or discomfort within 30 days prior to study blood draw No clinically significant finding by LDCT or ultrasound No clinically significant finding by breast ultrasound or Molybdenum Target Mammography Detection, or Thinprep cytologic test (TCT) detection for female participants No active hepatitis B or hepatitis C infection Exclusion Criteria for Non-tumor (Healthy) Arm Participants: Prior or ongoing treatment of cancer within 3 years prior to study blood draw Clinically significant or uncontrolled comorbidities

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>|
| Benign Diseases Arm<br>Participants with benign diseases corresponding to the tumor types in the Cancer Arm, 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 disease, 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 and specificity of early detection of 22 types of cancers and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model, in combination with serum tumor markers |  | 22 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in participants with cancers or benign diseases |  | 22 months | 
| Sensitivity and specificity of serum tumor markers, cfDNA methylation-based model, and a cfDNA methylation-based model combined with serum tumor markers, in participants with cancers and healthy participants |  | 22 months | 
| Sensitivity and specificity of early detection of cancer in different stages |  | 22 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), Early detection