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NCT Number: NCT06515587

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

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200040, China

Location status: Recruiting

Location contact

Jiang Long, MD

CONTACT

[email protected]

+86 18017317460

About this study

  • This study adopts a prospective, multicenter design, and classifies pancreatic cancer patients and predicts their prognosis through Lewis antigen detection and CA19-9 detection.
  • 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.
  • Evaluate the specificity of Lewis antigen detection by observing the distribution of Lewis subtypes in non pancreatic cancer subjects.
  • Explore the prognostic distribution of age, different Lewis subtypes, and overall survival cycle for Lewis antigen detection.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

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

    Time frame: Up to 12 months after the treatment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Long Jiang, MD

CONTACT

[email protected]

18017317460

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2024
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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