Mesenchymal CTC Ratio Dynamics Predicts Response and Survival in Pancreatic Ductal Adenocarcinoma With Neoadjuvant/Conversion Therapy

NCT ID: NCT07329920

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-10

Study Completion Date

2025-10-01

Brief Summary

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The aim of this study was to evaluate the clinical utility of mesenchymal CTC ratio dynamics as a real-time biomarker for PDAC patients with neoadjuvant therapy.

Detailed Description

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In this study, the investigators generated the largest PDAC patient cohort for CTC detection to date, which revealed mesenchymal CTC ratio dynamics as a robust biomarker during neoadjuvant therapy. The mesenchymal CTC ratio varied significantly across resectability status of PDAC with the highest level in the metastatic cohort. Moreover, the mesenchymal CTC ratio dynamics could be used for real-time assessment of neoadjuvant therapy response, accurate postoperative relapse surveillance and reliable prognostication.

Conditions

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Pancreatic Ductal Adenocarcinoma (PDAC) Circulating Tumor Cells (CTCs) Neoadjuvant Therapy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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none treatment group

No interventions assigned to this group

upfront surgery group

surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines

Intervention Type PROCEDURE

Retrospective studies do not require intervention measures.

neoadjuvant/conversion therapy without surgery group

No interventions assigned to this group

neoadjuvant/conversion therapy with surgery group

surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines

Intervention Type PROCEDURE

Retrospective studies do not require intervention measures.

Interventions

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surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines

Retrospective studies do not require intervention measures.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients who underwent CTC detection at the time of PDAC diagnosis were collected from the prospective database. All patients were pathologically confirmed with PDAC by endoscopic ultrasound guided fine-needle aspiration or surgical resection specimens. According to therapeutic modalities, these patients were divided into four subgroups: none treatment group, upfront surgery group, neoadjuvant/conversion therapy without surgery group and neoadjuvant/conversion therapy with surgery group. All patients provided written informed consent to use their clinical data and samples.

Exclusion Criteria

* Patients who could not tolerate neoadjuvant therapy or who had invasive intraductal papillary mucinous neoplasms, mucinous cystadenocarcinomas, or other non-pancreatic periampullary adenocarcinomas were excluded.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guo ShiWei

OTHER

Sponsor Role lead

Responsible Party

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Guo ShiWei

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Hepatobiliary and Pancreatic Surgery, First Affiliated Hospital of Naval Medical UniversityUniversity

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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Changhai Mesenchymal CTC R1

Identifier Type: -

Identifier Source: org_study_id

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