NCT06515587

Clinical Study of Lewis Antigen Assay Combined With CA19-9 Assay to Assess Prognosis in Patients With Pancreatic Cancer

To Evaluate a Prospective, Multicenter, Exploratory Clinical Study of Lewis Antigen Assay Combined With CA19-9 Assay to Assess Prognosis in Patients With Pancreatic Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

CA19-9 is an acidic glycoside containing sialic acid, called ganglioside. Lewis blood group antigen is the precursor for the synthesis of CA19-9, which is formed by the combined action of sialic acid transferase and fucosyltransferase (FUT3). The ability to produce soluble blood group substances is determined by the alpha (1,2) fucosyltransferase gene (FUT2), which can be divided into secretory Se, weakly secretory Sew, and non secretory SE. The Lewis antigen positive (Lewis+) population has normal CA19-9 secretion function, while the Lewis antigen negative (Lewis -) population (about 7%) usually shows no or low secretion of CA19-9. Therefore, when CA19-9 is used as a biomarker, the combined detection of Lewis antigen status is a marker to judge the prognosis of pancreatic cancer, which can divide pancreatic cancer patients into high/medium/low malignant phenotypes.

Detailed description

1. This study adopts a prospective, multicenter design, and classifies pancreatic cancer patients and predicts their prognosis through Lewis antigen detection and CA19-9 detection. 2. Observe the survival time of pancreatic cancer subjects to observe the consistency between Lewis typing and prognosis, and evaluate the sensitivity of Lewis antigen detection. 3. Evaluate the specificity of Lewis antigen detection by observing the distribution of Lewis subtypes in non pancreatic cancer subjects. 4. Explore the prognostic distribution of age, different Lewis subtypes, and overall survival cycle for Lewis antigen detection.

Conditions

• PDAC

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Lewis genotype detection reagent	By evaluating the results of the Lewis gene test combined with the CA19-9 test, different subtypes of pancreatic cancer patients were differentiated to evaluate the prognosis

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-06-30
• Completion: 2026-10-31
• First posted: 2024-07-23
• Last updated: 2025-05-14

Locations

1 site across 1 country: China