The Unintrusive Detection of EaRly-stage Cancers

Study Overview
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Brief Summary
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According to a previous study, a cell-free DNA (cfDNA) methylation-based model showed high sensitivity and specificity (80.6% and 98.3%) in blood-based multi-cancer detection. In this way, a multi-center, prospective, single-blind study (THUNDER study) is designed to further validate the performance of the cfDNA methylation-based model for early cancer detection. Blood RNA markers will also be evaluated. The study will enroll approximately 2508 participants, including participants with malignancies and healthy participants.

Official Title
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A Blinded Prospective Study on Validation of the Performance of a cfDNA Methylation-based Model for Early Cancer Detection

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 Ability to comply with study procedures Exclusion Criteria for All the 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 Inclusion Criteria for Cancer Arm Participants: Confirmed diagnosis or suspicious cases of cancer 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: Known prior or current diagnosis of other types of malignancies or multiple primary tumors Diagnosis of benign diseases by histopathological assessments No confirmed diagnosis of cancer by histopathological or radiological assessments within 42 days of study blood draw, or inability to characterize whether the lesion is malignant or benign Non-small-cell lung cancer patients with ground-class nodularity by radiological examination Diagnosis of precancerous lesions Inclusion Criteria for Healthy Arm Participants: No cancer-related symptoms or discomfort within 30 days prior to study blood draw No clinically significant finding by physical examinations, hematological assessment, urinalysis, 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 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>|
| 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 and specificity of early detection of 6 types of cancers and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model |  | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in different stages or pathological types of cancer |  | 7 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