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

NCT07329920 | Completed DMC

• 1 other identifier: Changhai Mesenchymal CTC R1
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

PDAC; Circulating tumor cells; Mesenchymal CTC ratio; Neoadjuvant therapy; Longitudinal detection; Cohort study

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival (OS) was defined as the interval from the date of diagnosis to the date of patient death or the last follow-up visit 1 month after surgery.

Secondary Outcomes (1)

• Recurrence-free survival

  Recurrence-free survival (RFS) was defined as the time interval from the date of diagnosis to the date of local or regional recurrence, distant metastases, death or the last follow-up visit 1 month after surgery.

Study Arms (4)

none treatment group

upfront surgery group

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

neoadjuvant/conversion therapy without surgery group

neoadjuvant/conversion therapy with surgery group

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

Interventions

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

Retrospective studies do not require intervention measures.

neoadjuvant/conversion therapy with surgery group; upfront surgery group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guo ShiWei: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Neoplastic Cells, Circulating

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 9, 2026
• Study Start: July 10, 2018
• Primary Completion: September 15, 2021
• Study Completion: October 1, 2025
• Last Updated: January 12, 2026

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)