NCT07176962

Brief Summary

Biliary tract carcinoma (BTC), including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma, ranks sixth in incidence among gastrointestinal malignancies and tenth in cancer-related mortality worldwide. Due to the lack of specific early symptoms, high malignancy, and frequent recurrence and metastasis, the rate of curative resection is only about 16.5%, and the overall 5-year survival rate is less than 5%. Early and accurate detection is therefore critical for improving patient outcomes. Circulating tumor DNA (ctDNA), a fraction of circulating free DNA (cfDNA), carries genetic and epigenetic information from tumor cells and can be detected even at the early stages of cancer development. Among various liquid biopsy biomarkers, ctDNA methylation shows particular advantages in sensitivity and specificity for early cancer detection and monitoring. This study aims to evaluate the application of cfDNA methylation liquid biopsy in the diagnosis and management of BTC.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

January 1, 2020

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

6.2 years

First QC Date

September 10, 2025

Last Update Submit

September 10, 2025

Conditions

Gall Bladder CancerIntrahepatic Cholangiocarcinoma (Icc)Extrahepatic CholangiocarcinomaHilar CholangiocarcinomaBilliary Track CancerctDNA

Keywords

ctDNA methylationEarly diagnosisLiquid biopsyBilliary Track Cancer

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance of the ctDNA methylation model in biliary tract cancer

    Evaluate the overall sensitivity, specificity, and accuracy of the ctDNA methylation liquid biopsy model in the diagnosis of biliary tract cancer (BTC).

    Baseline

Secondary Outcomes (3)

  • Subtype-specific diagnostic performance

    Baseline

  • Stage-specific diagnostic performance

    Baseline

  • Differential diagnosis

    Baseline

Other Outcomes (3)

  • Progression-Free Survival (PFS)

    From date of diagnosis until documented progression or death, whichever occurs first, up to 5 years.

  • Overall Survival (OS)

    From date of diagnosis until death from any cause, up to 5 years.

  • Recurrence monitoring performance

    Up to 5 years post-treatment

Study Arms (4)

control（Internal training and validation sets）

Healthy individuals Patients with pathologically confirmed benign biliary lesions Patients with other gastrointestinal malignancies

malignant（Internal training and validation sets）

patients with intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer

malignant (Independent validation set)

patients with suspected biliary tract malignancies

control (Independent validation set)

Healthy individuals

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population comprises individuals meeting inclusion criteria and not meeting any exclusion criteria.

You may qualify if:

  • BTC patients
  • Willing to voluntarily participate and able to comply with study procedures; if unable to read or sign, informed consent must be signed by a legally authorized representative (LAR).
  • Age 18-80 years (inclusive).
  • Able to provide required blood samples.
  • Pathologically confirmed biliary tract carcinoma (TNM stage I-IV).
  • Stable vital signs; ECOG performance status 0-1.
  • Adequate organ function: AST/ALT ≤ 5 × ULN; Child-Pugh class A or B; WBC \> 3 × 10⁹/L; ANC ≥ 1.5 × 10⁹/L; Platelets ≥ 75 × 10⁹/L; Hemoglobin ≥ 90 g/L; Creatinine clearance ≥ 60 mL/min; Total bilirubin ≤ 3 × ULN.
  • Other gastrointestinal malignancies (to exclude BTC non-specific signals)
  • Voluntary participation with signed informed consent (or by LAR).
  • Age 18-80 years (inclusive).
  • Able to provide required blood samples.
  • Pathologically confirmed gastrointestinal malignancies other than BTC, including hepatocellular carcinoma, gastric cancer, colorectal cancer, and pancreatic cancer (TNM stage I-IV).
  • Stable vital signs; ECOG performance status 0-1.
  • Non-cancer participants (benign biliary disease)
  • Able to provide written informed consent.
  • +15 more criteria

You may not qualify if:

  • Cancer patients
  • Pregnant or breastfeeding women.
  • History of organ transplantation or prior allogeneic bone marrow/stem cell transplantation.
  • Blood transfusion within 7 days prior to blood collection.
  • History of curative cancer treatment within 3 years prior to blood collection.
  • Use of anti-tumor drugs within 30 days prior to blood collection.
  • Known bleeding disorders.
  • Known autoimmune diseases.
  • Concurrent other malignancies or multiple primary tumors.
  • Non-cancer participants
  • Pregnant or breastfeeding women.
  • History of organ transplantation or prior allogeneic bone marrow/stem cell transplantation.
  • Blood transfusion within 7 days prior to blood collection.
  • History of any malignant tumor.
  • Known bleeding disorders.
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Related Publications (4)

  • Chung DC, Gray DM 2nd, Singh H, Issaka RB, Raymond VM, Eagle C, Hu S, Chudova DI, Talasaz A, Greenson JK, Sinicrope FA, Gupta S, Grady WM. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. N Engl J Med. 2024 Mar 14;390(11):973-983. doi: 10.1056/NEJMoa2304714.

    PMID: 38477985BACKGROUND

  • Nagino M, Hirano S, Yoshitomi H, Aoki T, Uesaka K, Unno M, Ebata T, Konishi M, Sano K, Shimada K, Shimizu H, Higuchi R, Wakai T, Isayama H, Okusaka T, Tsuyuguchi T, Hirooka Y, Furuse J, Maguchi H, Suzuki K, Yamazaki H, Kijima H, Yanagisawa A, Yoshida M, Yokoyama Y, Mizuno T, Endo I. Clinical practice guidelines for the management of biliary tract cancers 2019: The 3rd English edition. J Hepatobiliary Pancreat Sci. 2021 Jan;28(1):26-54. doi: 10.1002/jhbp.870. Epub 2020 Dec 23.

    PMID: 33259690BACKGROUND

  • Yang M, Zhao Y, Li C, Weng X, Li Z, Guo W, Jia W, Feng F, Hu J, Sun H, Wang B, Li H, Li M, Wang T, Zhang W, Jiang X, Zhang Z, Liu F, Hu H, Wu X, Gu J, Yang G, Li G, Zhang H, Zhang T, Zang H, Zhou Y, He M, Yang L, Wang H, Chen T, Zhang J, Chen W, Wu W, Li M, Gong W, Lin X, Liu F, Liu Y, Liu Y. Multimodal integration of liquid biopsy and radiology for the noninvasive diagnosis of gallbladder cancer and benign disorders. Cancer Cell. 2025 Mar 10;43(3):398-412.e4. doi: 10.1016/j.ccell.2025.02.011.

    PMID: 40068597BACKGROUND

  • Vogel A, Bridgewater J, Edeline J, Kelley RK, Klumpen HJ, Malka D, Primrose JN, Rimassa L, Stenzinger A, Valle JW, Ducreux M; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Feb;34(2):127-140. doi: 10.1016/j.annonc.2022.10.506. Epub 2022 Nov 10. No abstract available.

    PMID: 36372281BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

plasma

MeSH Terms

Conditions

Gallbladder NeoplasmsCholangiocarcinomaCirrhosis, Familial, with Pulmonary HypertensionKlatskin TumorDisease

Condition Hierarchy (Ancestors)

Biliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System DiseasesGallbladder DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yingbin Liu, PhD

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingbin Liu, PhD

CONTACT

+86 13918803900laoniulyb@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 10, 2025

First Posted

September 16, 2025

Study Start

January 1, 2020

Primary Completion

March 21, 2026

Study Completion

May 1, 2026

Last Updated

September 16, 2025

Record last verified: 2025-09

Locations

CN(1)