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

NCT ID: NCT05667350

Last Updated: 2022-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

492 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-28

Study Completion Date

2024-06-30

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.

Detailed Description

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Conditions

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Biliary Tract Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cancer arm

Baseline blood samples will be collected from participants newly diagnosed with biliary tract cancer.

Blood drawing

Intervention Type OTHER

Blood drawing before anti-cancer therapy

Benign disease arm

Baseline blood samples will be collected from participants newly diagnosed with benign biliary tract diseases.

Blood drawing

Intervention Type OTHER

Blood drawing before radical treatment

Interventions

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Blood drawing

Blood drawing before anti-cancer therapy

Intervention Type OTHER

Blood drawing

Blood drawing before radical treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.


* 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

* 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.


* 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Burning Rock Bioengineering Co., Ltd

UNKNOWN

Sponsor Role collaborator

Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiaoqing Jiang

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaoqing Jiang, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Eastern Hepatobiliary Surgery Hospital

Bin Li, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Eastern Hepatobiliary Surgery Hospital

Locations

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Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bin Li, MD/PhD

Role: CONTACT

Phone: +86-021-65564166

Email: [email protected]

Yuzi Zhang, MD/PhD

Role: CONTACT

Phone: +86-021-60293798

Email: [email protected]

Facility Contacts

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Leibo Xu, MD/PhD

Role: primary

Yuzi Zhang, MD/PhD

Role: backup

Bin Li, MD/PhD

Role: primary

Yuzi Zhang, MD/PhD

Role: backup

Other Identifiers

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RSCD2021021

Identifier Type: -

Identifier Source: org_study_id