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

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.

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