NCT05667350

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
492

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 28, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

December 30, 2022

Status Verified

December 1, 2022

Enrollment Period

1.8 years

First QC Date

December 19, 2022

Last Update Submit

December 28, 2022

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

  • The sensitivity and specificity of the combined model in detection of biliary tract cancers.

    24 months

Secondary Outcomes (2)

  • 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

Study Arms (2)

Cancer arm

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

Other: Blood drawing

Benign disease arm

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

Other: Blood drawing

Interventions

Blood drawingOTHER

Blood drawing before anti-cancer therapy

Cancer arm

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Guangzhou, Guangdong, 510120, China

NOT YET RECRUITING

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, 200438, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, white blood cells and fresh frozen tumor tissue

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Xiaoqing Jiang, MD/PhD

    Eastern Hepatobiliary Surgery Hospital

    PRINCIPAL INVESTIGATOR

  • Bin Li, MD/PhD

    Eastern Hepatobiliary Surgery Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bin Li, MD/PhD

CONTACT

+86-021-65564166libinjeff@126.com

Yuzi Zhang, MD/PhD

CONTACT

+86-021-60293798Z_Zhangyuzi@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 19, 2022

First Posted

December 28, 2022

Study Start

February 28, 2022

Primary Completion

December 31, 2023

Study Completion

June 30, 2024

Last Updated

December 30, 2022

Record last verified: 2022-12

Locations

CN(2)