EUS-guided CTCs + Multi-omics: Predicting Pancreatic Cancer Recurrence and Metastases

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorHuazhong University of Science and Technology

About this trial

The investigators conduct a single-center, prospective, observational study to explore the value of EUS-guided portal vein circulating tumor cells (PV-CTCs) and their subtypes combined with multi-omics tests in the early warning of recurrence and metastasis of resectable pancreatic cancer(RPC) and borderline resectable pancreatic cancer (BRPC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with solid masses (diameter > 1 cm) in the pancreatic area within the accessible range of endoscopic ultrasound, as indicated by clinical symptoms, laboratory tests, and imaging examinations (MRI, CT, B-ultrasound), who require biopsy to clarify the nature of the lesion.

Patients diagnosed with resectable pancreatic cancer, borderline resectable pancreatic cancer, locally advanced pancreatic cancer by imaging(CT/MRI).

Newly diagnosed pancreatic cancer patients who have not received radiotherapy or chemotherapy.

Signed informed consent form.

Disqualifiers

Patients with other active malignant tumors

Patients with coagulation dysfunction (PLT 50,000/mm3, INR > 1.5; roughly estimated, INR > 1.5 is approximately equivalent to PT > 18 seconds)

Pregnant women

Patients with hemorrhagic diseases

Trial population

Patients with pancreatic cancer from Tongji Hospital, Wuhan, scheduled for ultrasound-guided fine-needle aspiration biopsy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • CTC

    Diagnostic test

    Obtaining portal vein blood and peripheral blood from patients, extracting circulating tumor cells (CTCs) therein, and performing CTC sorting, thereby assisting clinical evaluation of the applicability of neoadjuvant therapy and prognostic assessment for patients with potentially resectable pancreatic cancer.

Treatment groups

20 Participants
are divided into 3 treatment groups
Group A: RPC1 intervention
Group B: BRPC1 intervention
Group C: LAPC1 intervention

Trial outcomes

Primary outcomes

1

Number of circulating tumor cells in the portal vein

Explore the value of the number of circulating tumor cells in the portal vein in evaluating the applicability of neoadjuvant therapy and guiding treatment decisions for BRPC patients

Time frame
Up to 24 months
2

Subpopulation classification of portal vein circulating tumor cells

Explore the application of portal vein circulating tumor cell subset classification in the prognostic evaluation of neoadjuvant therapy in BRPC patients

Time frame
Up to 24 months

Secondary outcomes

1

Subgroup Classification of Portal Vein Circulating Tumor Cells (PV-CTCs) and Peripheral Blood Circulating Tumor Cells (PB-CTCs)

Explore the differences in subpopulation classification between portal vein circulating tumor cells (PV-CTCs) and peripheral blood circulating tumor cells (PB-CTCs), and investigate their roles in the process of liver metastasis of pancreatic cancer.

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

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