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

NCT06515587 | Recruiting

• 1 other identifier: Lewis-IIT-202401
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

PDAC

Outcome Measures

Primary Outcomes (1)

• To explore the prognosis of pancreatic cancer with the combination of the Lewis antigen test and the CA19-9 test

  The phenotypes of pancreatic cancer patients were classified by Lewis antigen test combined with CA19-9 test.Monitoring patients' disease expression and assisting clinical selection of targeted treatment plan.The consistency between Lewis classification and prognosis was assessed by looking at the survival of pancreatic cancer subjects following clinical treatment regimens.

  Up to 12 months after the treatment

Study Arms (1)

Study group

EXPERIMENTAL

All enrolled subjects will accurately complete one Lewis genotype test and at least one CA19-9 test

Diagnostic Test: Lewis genotype detection reagent

Interventions

Lewis genotype detection reagent DIAGNOSTIC_TEST

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

Study group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily enrolled, regardless of gender, aged ≥ 18 and ≤ 75 years old, and the patient can understand and is willing to sign an informed consent form;
• ECOG 0-2
• Pathologically confirmed as pancreatic ductal adenocarcinoma; Or confirmed by pathology and clinical examination as pancreatic ductal adenocarcinoma.
• Willing to accept routine CA19-9 testing, Lewis antigen sample collection and testing (2-3ml), and follow-up Non pancreatic cancer subjects enrolled in this study must meet all the following criteria
• \. Voluntary enrollment, regardless of gender, age ≥ 18 years, ≤ 75 years old, and the patient can understand and is willing to sign an informed consent form 2. Willing to accept Lewis antigen sample collection and testing (2-3ml)

You may not qualify if:

• Suffering from the second or double primary malignant tumor besides pancreatic cancer at the same time
• Patients with pancreatic cancer who cannot trace the specific anti-cancer treatment plan
• HIV positive
• Other situations that researchers believe need to be excluded

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Central Study Contacts

Long Jiang, MD

CONTACT

18017317460; jiang.long@shgh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of pancreatic surgery

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 23, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

CN (1)