Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515587
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-25
Brief Title:
Clinical Study of Lewis Antigen Assay Combined With CA19-9 Assay to Assess Prognosis in Patients With Pancreatic Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 12 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 highmediumlow 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None