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

Exploration and Validation of a Diagnosis Model for Biliary Tract Cancer Based on Combined Liquid Biopsy in Peripheral Blood: A Multi-center Prospective Study

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 consent
• Pathologically 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.