G-Precision trial

JRCT ID: jRCT1032230578

Registered date:19/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic Cancer
• Date of first enrollment: 15/03/2024
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Allocated 1:1 between 22G FNB and 19G FNB groups

Outcome(s)

• Primary Outcome: The success rate of CGP testing

Secondary Outcome

1) Procedural success rate
2) Tissue sample collection rate
3) Diagnosis rate of benign and malignant cases
4) CGP proper specimen collection rate
5) DNA yield
6)Detection rate of genetic abnormality of therapeutic target
7)TMB
8)Adverse events by EUS-TA
9)Tissue area, tumor (cell) content*, and tumor (area) content by HE staining

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients with unresectable advanced or recurrent pancreatic cancer diagnosed by pathological or imaging findings
2) Patients who are scheduled to undergo EUS-TA
3) Patients who are scheduled to undergo CGP examination using EUS-TA specimen at the time of completion or expected completion of standard treatment.
4) 18 years of age or older
5) Patients who are expected to survive more than 3 months.
6) Patients who have been fully informed about the study, understand it, and give written consent of their own free will.

Exclude criteria

1) Patients with resectable pancreatic cancer or borderline resectable pancreatic cancer who are scheduled for surgery in the future
2) Patients with performance status 3-4
3) Patients who have difficulty in receiving anti-tumor therapy
4) Patients with bleeding tendency (platelets <50,000/mm3, PT <70%) (however, patients who recover with blood transfusion or vitamin K administration may be enrolled)
5) Patients at high risk of thromboembolism due to withdrawal of antithrombotic drugs and for whom withdrawal or replacement of antithrombotic drugs based on the "Guidelines for Gastrointestinal Endoscopy for Patients Taking Antithrombotic Drugs" is not possible.
6) Patients with heart failure (NYHA classification III-IV) or respiratory failure (PaO2 < 60 Torr)
7) Patients who are pregnant or may become pregnant
8) Other cases that the principal investigator determines to be inappropriate as a research subject.

Related Information

• Primary Sponsor: Takahara Naminatsu