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Completed

NCT Number: NCT04835675

AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Hepatobiliary Cancer Malignancies

This study is a prospective, multicenter study aimed to develop and validate the performance of combined assays for cfDNA methylation markers and serum tumor markers in early hepatobiliary malignancies detection. Circulating tumor DNA (ctDNA) mutation, blood RNA markers and tissue will also be evaluated. The study will enroll approximately 496 participants, including participants with malignant or benign diseases of the hepatobiliary system.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhujiang Hospital

Guangzhou, Guangdong, 510280, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for All the Participants:

  • 40-75 years old
  • Ability to comply with study procedures
  • Ability to provide a written informed consent

Exclusion criteria

for All the 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 anti-microbial therapy within 14 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 cancer

Inclusion criteria

for Cancer Arm Participants:

  • Confirmed diagnosis or highly suspicious cases of hepatobiliary malignancies
  • No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw

Exclusion criteria

for Cancer Arm Participants:

  • Current diagnosis of other malignancies or multiple primary tumors
  • Diagnosis of benign diseases by histopathological assessments
  • Inability to characterize whether the lesion is malignant or benign
  • Prior or ongoing treatment of cancer

Inclusion criteria

for Benign Diseases Arm Participants:

  • Confirmed diagnosis of benign diseases of the hepatobiliary system
  • No prior radical treatment of the benign diseases prior to study blood draw

Exclusion criteria

for Benign Diseases Arm Participants:

  • Current or history of malignancies or precancerous lesions
  • No confirmed diagnosis or inability to characterize a benign disease

Treatment and study plan

Multi-Cancer Early Detection Test

Device

Blood collection and multi-cancer early detection testing

Primary outcomes

  1. Sensitivity of early hepatobiliary malignancies detection and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model combined with serum tumor markers when specificity was 90%, 95% or 98%

    Time frame: 16 months

  2. Sensitivity and specificity of early hepatobiliary malignancies detection and TOO accuracy of a cfDNA methylation-based model combined with serum tumor markers

    Time frame: 16 months

Secondary outcomes

  1. Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in early detection of hepatobiliary malignancies in different stages

    Time frame: 16 months

  2. Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers, clinical characteristics and other biomarkers

    Time frame: 16 months

  3. Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in participants with malignant or benign diseases of the hepatobiliary system

    Time frame: 16 months

  4. Sensitivity and specificity of a cfDNA methylation-based model or serum tumor markers in participants with hepatobiliary malignancies

    Time frame: 16 months

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Collaborators

  • Guangzhou BR

Registry information

Official study title

Development and Validation of the Performance of a cfDNA Methylation-based Model Combined With Serum Tumor Markers for Early Hepatobiliary Malignancies Detection

Acronym: ASCEND-Hep

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2021
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.