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

Biliary Tract Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05667350
• Other study ID #: RSCD2021021
• Status: Recruiting
• Start date: February 28, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2022
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: Bin Li, MD/PhD
• Phone: +86-021-65564166
• Email: libinjeff[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 492
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

Other:
• Blood drawing
Blood drawing before anti-cancer therapy
• Blood drawing
Blood drawing before radical treatment

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Eastern Hepatobiliary Surgery Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital	Guangzhou Burning Rock Bioengineering Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sensitivity and specificity of the combined model in detection of biliary tract cancers.		24 months
Secondary	The sensitivity and specificity of the combined model in detection of different subtypes of biliary tract cancers.		24 months
Secondary	The sensitivity and specificity of the combined model in detection of different stages of biliary tract cancers.		24 months