Biliary Tract Cancer
Conditions
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.
Interventions
OTHERBlood drawing
Blood drawing before anti-cancer therapy
Sponsors
Guangzhou Burning Rock Bioengineering Co., Ltd
Eastern Hepatobiliary Surgery Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity and specificity of the combined model in detection of biliary tract cancers. | 24 months |
Secondary
| Measure | 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 |
Countries
China
Contacts
Primary ContactBin Li, MD/PhD
Backup ContactYuzi Zhang, MD/PhD
Outcome results
None listed