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

Naval Military Medical University (Second Military Medical University)

Status: Enrolling

Conditions: Biliary Tract Cancer

Treatments: Other: Blood drawing

Study type: Observational

Funder types: Other

Identifiers

NCT05667350

RSCD2021021

Details and patient eligibility

About

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.

Enrollment: 492 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

492 participants in 2 patient groups

Cancer arm

Description:

Baseline blood samples will be collected from participants newly diagnosed with biliary tract cancer.

Treatment:

Other: Blood drawing

Other: Blood drawing

Benign disease arm

Description:

Baseline blood samples will be collected from participants newly diagnosed with benign biliary tract diseases.

Treatment:

Other: Blood drawing

Other: Blood drawing