Clinical trial NCT05667350: AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Biliary Tract Cancer (ASCEND-BTC)
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biliary Tract Cancer
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
Collaborators: name: Guangzhou Burning Rock Bioengineering Co., Ltd
First posted: 2022-12-28
Enrollment: 492
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible participants will be recruited from participating medical centers and assigned into two arms, including participants with new diagnosis of biliary tract cancer and benign biliary tract diseases.

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.


Eligibility 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.

Primary outcomes:
measure: The sensitivity and specificity of the combined model in detection of biliary tract cancers.
timeFrame: 24 months
Secondary outcomes:
measure: The sensitivity and specificity of the combined model in detection of different subtypes of biliary tract cancers.
timeFrame: 24 months
measure: The sensitivity and specificity of the combined model in detection of different stages of biliary tract cancers.
timeFrame: 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital
state: Shanghai
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital
name: Xiaoqing Jiang, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastern Hepatobiliary Surgery Hospital
name: Bin Li, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: