AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Biliary Tract Cancer (ASCEND-BTC)

ASCEND-BTC is a prospective, multi-center, observational study aimed at detecting early biliary tract cancer by combined assays of serum protein and cell-free DNA (cfDNA) methylation. The study will enroll approximately 492 participants diagnosed with biliary tract cancer and benign diseases.

Inclusion Criteria for Cancer Arm Participants:Age 40-75 years at the day of consenting to the study.Able to provide a written informed consentPathologically confirmed biliary tract cancers.No prior or ongoing 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 cancers.With other known malignant tumors or multiple primary tumors.Inclusion Criteria for Benign Arm Participants:Age 40-75 years at the day of consenting to the study.Able to provide a written informed consent.Confirmed diagnosis of benign biliary tract diseases.No prior radical treatment of the benign diseases prior to study blood draw.Exclusion Criteria for Benign 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 cancers.Confirmed diagnosis of malignancies or precancerous lesion.A history of malignant tumors.