Exploratory study to elucidate the significance of biomarker measurement by liquid biopsy over time in patients with hepatobiliary and pancreatic malignancies during systemic therapy

Exploratory study to elucidate the significance of biomarker measurement by liquid biopsy over time in patients with hepatobiliary and pancreatic malignancies during systemic therapy - Liquid biopsy study during systemic therapy for hepatobiliary pancreatic cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000050100

Enrollment

1000

Registered

2023-01-24

Start date

2023-01-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepato-biliary pancreatic malignant tumor

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with hepatobiliary and pancreatic malignancies who will receive systemic therapy at Fujita Health University Hospital 2. Patients with a histological or clinical (imaging and tumor markers) diagnosis of hepatobiliary and pancreatic malignancies 3. Patients unsuitable for surgical resection or local therapy 4. Patients with ECOG Performance Status (PS) of 0,1,2 5. Patients over 20 years old 6. Patients with preserved major organ function 7. Patients in which the patient's consent to participate in this study has been obtained

Exclusion criteria

Exclusion criteria: 1. Patients with serious complications 2. Patients who are judged by the investigator to be ineligible for the safe conduct of this study

Design outcomes

Primary

Measure	Time frame
The relationship between blood ctDNA profile over time and anti-tumor response	—

Secondary

Measure	Time frame
The relationship between the treatment outcome and CTCs, miRNAs, tumor markers, cancer immune-related factors, and intestinal microbiota obtained from liquid biopsies (blood, urine, saliva, and stool samples) other than ctDNA.	—

Countries

Japan

Contacts

Public ContactTeiji Kuzuya

Fujita Health University Department of Gastroenterology and Hepatology

teiji.kuzuya@fujita-hu.ac.jp+81562932324

Outcome results