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

Study Overview
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Brief Summary
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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.

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

Conditions
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Biliary Tract Cancer

Intervention / Treatment
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* Other: Blood drawing
* Other: Blood drawing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer arm<br>Baseline blood samples will be collected from participants newly diagnosed with biliary tract cancer. | Other: Blood drawing<br>* Blood drawing before anti-cancer therapy<br>|
| Benign disease arm<br>Baseline blood samples will be collected from participants newly diagnosed with benign biliary tract diseases. | Other: Blood drawing<br>* Blood drawing before radical treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity and specificity of the combined model in detection of biliary tract cancers. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity and specificity of the combined model in detection of different subtypes of biliary tract cancers. |  | 24 months | 
| The sensitivity and specificity of the combined model in detection of different stages of biliary tract cancers. |  | 24 months |