NCT07448376

Brief Summary

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).

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
17mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress23%
Mar 2026Dec 2027

First Submitted

Initial submission to the registry

February 25, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

March 4, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

February 25, 2026

Last Update Submit

February 25, 2026

Conditions

CTCsPancreatic CancerLiver MetastasesRelapseBorderline Resectable Pancreatic CancerResectable Pancreatic CancersEUS

Keywords

EUSCTCPancreatic CancermetastasesrelapseBRPCRPC

Outcome Measures

Primary Outcomes (2)

  • 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

    Up to 24 months

  • 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

    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)

    Up to 24 months

Study Arms (3)

RPC

Patients diagnosed with resectable pancreatic cancer by imaging (CT/MRI)

Diagnostic Test: CTC

BRPC

Patients diagnosed with borderline resectable pancreatic cancer by imaging (CT/MRI)

Diagnostic Test: CTC

LAPC

Patients diagnosed with locally advanced pancreatic cancer by imaging (CT/MRI)

Diagnostic Test: CTC

Interventions

CTCDIAGNOSTIC_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.

BRPCLAPCRPC

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.
  • Patients must be able to comply with the trial requirements.

You may not qualify if:

  • 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
  • Patients with a history of taking anticoagulant drugs such as aspirin and warfarin in the past week
  • Patients with absolute contraindications to EUS examination, a history of acute pancreatitis within the past 2 weeks, a history of gastric surgery, pregnancy, severe diseases, or a history of allergy to anesthetics
  • Patients whose EUS examination was terminated early due to esophageal stenosis, obstruction, large space-occupying lesions, rapid changes in the patient's heart rate or respiratory rate, patient intolerance, or a large amount of food residue, etc.
  • Patients with known hepatitis C virus infection
  • Patients with known human immunodeficiency virus (HIV) infection
  • Patients with imaging examinations, EUS results, etc., suggesting pancreatic cystic space-occupying lesions
  • Patients who have received radiotherapy or chemotherapy
  • Patients with incomplete pathological information, unable to make a clear diagnosis, or unable to sign the informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, HUST

Wuhan, Hubei, 430030, China

Location

Related Publications (9)

  • Chen L, Chen M, Chen J. [Advances of circulating biomarkers in gastroenteropancreatic neuroendocrine neoplasms]. Zhonghua Wei Chang Wai Ke Za Zhi. 2017 Mar 25;20(3):357-360. Chinese.

    PMID: 28338171RESULT

  • Catenacci DV, Chapman CG, Xu P, Koons A, Konda VJ, Siddiqui UD, Waxman I. Acquisition of Portal Venous Circulating Tumor Cells From Patients With Pancreaticobiliary Cancers by Endoscopic Ultrasound. Gastroenterology. 2015 Dec;149(7):1794-1803.e4. doi: 10.1053/j.gastro.2015.08.050. Epub 2015 Sep 2.

    PMID: 26341722RESULT

  • Wang JX, Lu LG, Cai XB. Endoscopic ultrasound for the diagnosis and treatment of primary hepatocellular carcinoma. J Dig Dis. 2024 Mar;25(3):156-162. doi: 10.1111/1751-2980.13266. Epub 2024 Apr 17.

    PMID: 38628105RESULT

  • Zhu Z, Zhang Y, Zhang W, Tang D, Zhang S, Wang L, Zou X, Ni Z, Zhang S, Lv Y, Xiang N. High-throughput enrichment of portal venous circulating tumor cells for highly sensitive diagnosis of CA19-9-negative pancreatic cancer patients using inertial microfluidics. Biosens Bioelectron. 2024 Sep 1;259:116411. doi: 10.1016/j.bios.2024.116411. Epub 2024 May 20.

    PMID: 38781696RESULT

  • Chinese Pancreatic Surgery Association, Chinese Society of Surgery, Chinese Medical Association. [Guidelines for the diagnosis and treatment of pancreatic cancer in China(2021)]. Zhonghua Wai Ke Za Zhi. 2021 Jul 1;59(7):561-577. doi: 10.3760/cma.j.cn112139-20210416-00171. Chinese.

    PMID: 34256456RESULT

  • Park W, Chawla A, O'Reilly EM. Pancreatic Cancer: A Review. JAMA. 2021 Sep 7;326(9):851-862. doi: 10.1001/jama.2021.13027.

    PMID: 34547082RESULT

  • Ielpo B, Caruso R, Duran H, Diaz E, Fabra I, Malave L, Ferri V, Alvarez R, Cubillo A, Plaza C, Lazzaro S, Kalivaci D, Quijano Y, Vicente E. A comparative study of neoadjuvant treatment with gemcitabine plus nab-paclitaxel versus surgery first for pancreatic adenocarcinoma. Surg Oncol. 2017 Dec;26(4):402-410. doi: 10.1016/j.suronc.2017.08.003. Epub 2017 Aug 24.

    PMID: 29113659RESULT

  • Pan L, Fang J, Tong C, Chen M, Zhang B, Juengpanich S, Wang Y, Cai X. Survival benefits of neoadjuvant chemo(radio)therapy versus surgery first in patients with resectable or borderline resectable pancreatic cancer: a systematic review and meta-analysis. World J Surg Oncol. 2019 Dec 31;18(1):1. doi: 10.1186/s12957-019-1767-5.

    PMID: 31892339RESULT

  • Crippa S, Belfiori G, Bissolati M, Partelli S, Pagnanelli M, Tamburrino D, Gasparini G, Rubini C, Zamboni G, Falconi M. Recurrence after surgical resection of pancreatic cancer: the importance of postoperative complications beyond tumor biology. HPB (Oxford). 2021 Nov;23(11):1666-1673. doi: 10.1016/j.hpb.2021.04.004. Epub 2021 Apr 20.

    PMID: 33934960RESULT

Biospecimen

Retention: SAMPLES WITH DNA

portal vein blood \& peripheral blood

MeSH Terms

Conditions

Pancreatic NeoplasmsRecurrenceNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplastic Processes

Study Officials

  • Bin Cheng

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bin Cheng

CONTACT

+8613986097542b.cheng@tjh.tjmu.edu.cn

Qingxiong Ma

CONTACT

13588580316u202110372@hust.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 4, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

March 4, 2026

Record last verified: 2026-02

Locations

CN(1)