AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Biliary Tract Cancer (ASCEND-BTC)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cancer arm Baseline blood samples will be collected from participants newly diagnosed with biliary tract cancer. |
Other: Blood drawing
Blood drawing before anti-cancer therapy
|
| Benign disease arm Baseline blood samples will be collected from participants newly diagnosed with benign biliary tract diseases. |
Other: Blood drawing
Blood drawing before radical treatment
|
Outcome Measures
Primary Outcome Measures
- The sensitivity and specificity of the combined model in detection of biliary tract cancers. [24 months]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China | 510120 |
| 2 | Eastern Hepatobiliary Surgery Hospital | Shanghai | Shanghai | China | 200438 |
Sponsors and Collaborators
- Eastern Hepatobiliary Surgery Hospital
- Guangzhou Burning Rock Bioengineering Co., Ltd
Investigators
- Principal Investigator: Xiaoqing Jiang, MD/PhD, Eastern Hepatobiliary Surgery Hospital
- Principal Investigator: Bin Li, MD/PhD, Eastern Hepatobiliary Surgery Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RSCD2021021