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Trial Title:
AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Biliary Tract Cancer (ASCEND-BTC)
NCT ID:
NCT05667350
Condition:
Biliary Tract Cancer
Conditions: Official terms:
Biliary Tract Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Blood drawing
Description:
Blood drawing before anti-cancer therapy
Arm group label:
Cancer arm
Intervention type:
Other
Intervention name:
Blood drawing
Description:
Blood drawing before radical treatment
Arm group label:
Benign disease arm
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
40 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Leibo Xu, MD/PhD
Contact backup:
Last name:
Yuzi Zhang, MD/PhD
Phone:
+86-021-60293798
Email:
Z_Zhangyuzi@163.com
Facility:
Name:
Eastern Hepatobiliary Surgery Hospital
Address:
City:
Shanghai
Zip:
200438
Country:
China
Status:
Recruiting
Contact:
Last name:
Bin Li, MD/PhD
Phone:
+86-021-65564166
Email:
libinjeff@126.com
Contact backup:
Last name:
Yuzi Zhang, MD/PhD
Phone:
+86-021-60293798
Email:
Z_Zhangyuzi@163.com
Start date:
February 28, 2022
Completion date:
June 30, 2024
Lead sponsor:
Agency:
Eastern Hepatobiliary Surgery Hospital
Agency class:
Other
Collaborator:
Agency:
Guangzhou Burning Rock Bioengineering Co., Ltd
Agency class:
Other
Source:
Eastern Hepatobiliary Surgery Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05667350
