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

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.

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