Cancer
Conditions
Keywords
Cancer, Cell-free DNA (cfDNA) methylation, Early detection
Brief summary
PREDICT is a prospective, multicenter study for the early detection of pan-cancer through cell-free DNA (cfDNA) methylation-based model, in which approximately 14,000 participants will be enrolled. The development and validation of the model will be conducted in participants with cancers or benign diseases, along with non-tumor (healthy) individuals through a two-stage approach. The sensitivity and specificity of the model in cancer early detection will be evaluated, and the accuracy of the identification for tissue of origin will be obtained.
Interventions
Blood collection and multi-cancer early detection testing
Sponsors
Guangzhou Burning Rock Dx Co., Ltd.
Shanghai Zhongshan Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
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 of a cancer or highly suspicious cases of cancer within 42 days prior to study blood draw. Tumor types in this study include lung cancer, colorectal cancer, liver cancer, ovarian cancer, gastric cancer, esophageal cancer, pancreatic cancer, biliary tract cancer, squamous cell carcinoma of the head and neck (except nasopharyngeal carcinoma) * No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity of early detection of cancer and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model when specificity is 90%, 95% or 98% in healthy participants | 24 months |
| Sensitivity and specificity of early detection of cancer and TOO accuracy of a cfDNA methylation-based model | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in various types of cancer | 24 months |
| Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in different stages of cancer | 24 months |
| Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model, in combination with clinical characteristics and other biomarkers | 24 months |
Countries
China
Contacts
Primary ContactQiang Gao, M.D.
Backup ContactShangli Cai, Ph.D
Outcome results
None listed