NCT07045181

Brief Summary

This study aims to develop XGBoost machine learning model to predict pancreatic neoplasms in CP patients with focal pancreatic lesions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 22, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2025

Completed
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

1 month

First QC Date

June 22, 2025

Last Update Submit

September 25, 2025

Conditions

Keywords

Pancreatic neoplasmchronic pancreatitismachine learningSHAP

Outcome Measures

Primary Outcomes (1)

  • Diagnostic yield

    The diagnostic yield of XGBoost machine learning, including AUC、Sensitivity、Specificity

    10 years

Study Arms (2)

Pancreatic neoplasm group

This cohort consists of chronic pancreatitis patients whose focal pancreatic lesions were diagnosed as pancreatic neoplasm

Diagnostic Test: XGBoost machine learning

Non-pancreatic neoplasm group

This cohort consists of chronic pancreatitis patients whose focal pancreatic lesions were diagnosed as benign lesions

Diagnostic Test: XGBoost machine learning

Interventions

XGBoost is a powerful machine learning algorithm known for its efficiency and performance. It is an optimized gradient boosting library designed to be highly efficient, flexible, and portable. XGBoost works by combining multiple weak prediction models, typically decision trees, to produce a strong predictive model. It supports various objective functions and evaluation metrics, making it suitable for a wide range of tasks, including classification and regression. XGBoost also includes features like regularization to prevent overfitting and can handle missing data effectively.

Non-pancreatic neoplasm groupPancreatic neoplasm group

Eligibility Criteria

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

Chronic pancreatitis patients who has indeterminate focal pancreatic lesions discovered through contrast-enhanced CT scans

You may qualify if:

  • Diagnosis of chronic pancreatitis
  • Patients has indeterminate focal pancreatic lesions discovered through contrast-enhanced CT scans

You may not qualify if:

  • Patients had incomplete clinical data
  • Patients had no surgical pathology results for the focal pancreatic lesions and loss to follow-up, indicating that a final diagnosis of the focal pancreatic lesions could not been established

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (3)

  • Kirkegard J, Mortensen FV, Cronin-Fenton D. Chronic Pancreatitis and Pancreatic Cancer Risk: A Systematic Review and Meta-analysis. Am J Gastroenterol. 2017 Sep;112(9):1366-1372. doi: 10.1038/ajg.2017.218. Epub 2017 Aug 1.

    PMID: 28762376BACKGROUND
  • Hao L, Zeng XP, Xin L, Wang D, Pan J, Bi YW, Ji JT, Du TT, Lin JH, Zhang D, Ye B, Zou WB, Chen H, Xie T, Li BR, Zheng ZH, Wang T, Guo HL, Liao Z, Li ZS, Hu LH. Incidence of and risk factors for pancreatic cancer in chronic pancreatitis: A cohort of 1656 patients. Dig Liver Dis. 2017 Nov;49(11):1249-1256. doi: 10.1016/j.dld.2017.07.001. Epub 2017 Jul 15.

    PMID: 28756974BACKGROUND
  • Korpela T, Udd M, Mustonen H, Ristimaki A, Haglund C, Seppanen H, Kylanpaa L. Association between chronic pancreatitis and pancreatic cancer: A 10-year retrospective study of endoscopically treated and surgical patients. Int J Cancer. 2020 Sep 1;147(5):1450-1460. doi: 10.1002/ijc.32971. Epub 2020 Apr 3.

    PMID: 32162688BACKGROUND

MeSH Terms

Conditions

Pancreatitis, ChronicPancreatic Neoplasms

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 22, 2025

First Posted

July 1, 2025

Study Start

July 1, 2025

Primary Completion

August 1, 2025

Study Completion

August 5, 2025

Last Updated

September 30, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations