NCT06302881

Brief Summary

This study introduces a novel transfer learning-based contrastive language-image pretraining adapter (CLIP-adapter) model for predicting the tumor-stroma ratio (TSR) in pancreatic ductal adenocarcinoma (PDAC) using preoperative dual-phase CT images. The primary aim is to develop an efficient and accessible tool for risk stratification and personalized treatment planning.

Trial Health

53
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Status
active not 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 Start

First participant enrolled

January 1, 2013

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 29, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
Last Updated

March 12, 2024

Status Verified

February 1, 2024

Enrollment Period

9.5 years

First QC Date

February 29, 2024

Last Update Submit

March 7, 2024

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

Pancreatic ductal adenocarcinomaTumor stroma ratioContrastive language-image pretrainingSelf-attention mechanismMulti-modality feature fusion

Outcome Measures

Primary Outcomes (1)

  • The diagnostic AUC value of pancreatic ductal adenocarcinoma with deep learning algorithm.

    AUC=(Sensitivity+Specificity)-1

    1 year

Secondary Outcomes (5)

  • The diagnostic accuracy of pancreatic ductal adenocarcinoma with deep learning algorithm.

    1 year

  • The diagnostic sensitivity of pancreatic ductal adenocarcinoma with deep learning algorithm.

    1 year

  • The diagnostic specificity of pancreatic ductal adenocarcinoma with deep learning algorithm.

    1 year

  • The diagnostic positive predictive value of pancreatic ductal adenocarcinoma with deep learning algorithm.

    1 year

  • The diagnostic negative predictive value of pancreatic ductal adenocarcinoma with deep learning algorithm.

    1 year

Study Arms (1)

low TSR and high TSR group

The assessment of the tumor-stroma ratio (TSR) entailed measuring the percentage of tumor and stroma constituents. Based on earlier research, 5/5 was deemed as ideal threshold of TSR measurement.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A total of 207 patients were chosen from three independent4 hospitals: the First Affiliated Hospital of Chongqing Medical University (FAHCQMU), Daping Hospital of Army Medical University (DPHAMU), and the Third Affiliated Hospital of Chongqing Medical University (TAHCQMU).

You may qualify if:

  • patients with pathologically proven PDAC by surgical resection
  • patients who underwent CT scan within a month before surgery
  • observable pancreatic lesions on available images.

You may not qualify if:

  • any anti-cancer therapy before CT scanning
  • conspicuous interference or significant motion distortions found on images
  • partial clinical data
  • patients with liver metastases or peritoneal carcinomatosis prior to surgical intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator, department of radiology,the first affiliated hospital of chongqing medical university

Study Record Dates

First Submitted

February 29, 2024

First Posted

March 12, 2024

Study Start

January 1, 2013

Primary Completion

July 1, 2022

Study Completion

March 1, 2024

Last Updated

March 12, 2024

Record last verified: 2024-02